Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02951052
• Collaborator: Janssen Pharmaceuticals (Industry), GlaxoSmithKline (Industry)
• Enrollment: 618
• Locations: 115
• Arms: 2
• Anticipated Duration (Months): 87.4
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA

• RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus; HIV Infections	Drug: Cabotegravir (CAB) tablet; Drug: Rilpivirine (RPV) tablet; Drug: Cabotegravir - Injectable Suspension (CAB LA); Drug: Rilpivirine - Injectable Suspension (RPV LA); Drug: 2 NRTIs plus an INI, NNRTI, or PI	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 618 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed
• Actual Study Start Date: Oct 28, 2016
• Actual Primary Completion Date: May 29, 2018
• Anticipated Study Completion Date: Feb 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAB LA + RPV LA every 4 weeks Eligible subjects receive Oral CAB 30 mg + RPV 25 mg once daily for four weeks, IM CAB LA 600 mg and RPV LA 900 mg for the first injection, and Week 4 onwards subjects will receive CAB LA (400 mg) + RPV LA (600 mg) injections every 4 weeks until withdrawal.	Drug: Cabotegravir (CAB) tablet; It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat; Drug: Rilpivirine (RPV) tablet; It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose; Drug: Cabotegravir - Injectable Suspension (CAB LA); It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection; Drug: Rilpivirine - Injectable Suspension (RPV LA); It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
Active Comparator: Current antiretroviral regimen Eligible subjects will continue their current anti-retroviral regimen (2 NRTIs plus an INI, NNRTI, or a PI) for 52 weeks. After 52 weeks subjects have the option to continue study participation by switching to CAB LA + RPV LA in the Extension Phase where they will follow the procedure of CAB LA + RPV LA arm.	Drug: 2 NRTIs plus an INI, NNRTI, or PI; Acceptable stable (initial or second) ARV regimens include 2 NRTIs plus: INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen) NNRTI (either the initial or second cART regimen) Boosted PI (or atazanavir [ATV] unboosted) (either the initial or second PI-based cART regimen)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48 [Week 48]

   Number of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.

Secondary Outcome Measures

1. Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48 [Week 48]

   Plasma samples were collected for quantitative analysis of HIV-1 RNA. Number of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.

2. Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48 [Week 48]

   Number of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART.

3. Number of Participants With Confirmed Virologic Failure (CVF) [Weeks 8, 12, 20, 24, 32 and 40]

   The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. The outcome displays only visits during which at least one new CVF occurs. Plasma samples were collected for quantitative analysis of HIV-1 RNA.

4. Absolute Values for Plasma HIV-1 RNA at Week 48 [Week 48]

   Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.

5. Change From Baseline Values for Plasma HIV-1 RNA [Baseline and Week 48]

   Plasma for quantitative HIV-1 RNA were collected at indicated time points. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 - HIV-1 RNA(log 10) at Baseline.

6. Absolute Values for CD4+ Lymphocyte Count at Week 48 [Week 48]

   Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.

7. Change From Baseline Values for CD4+ Lymphocyte Count at Week 48 [Baseline (Day 1) and Week 48]

   Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value at Week 48 minus Baseline value.

8. Number of Participants With Disease Progression [Up to Week 48]

   Disease progression was defined as HIV-associated conditions, acquired immunodeficiency syndrome (AIDS), and death through 48 Weeks. Data of participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented.

9. Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) [Up to Week 48]

   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of IP during the maintenance phase of the study (on or after Day 1 visit). Participants will be assessed according to actual treatment received.

10. Number of Participants With Severity of Adverse Events [Up to Week 48]

    Severity of adverse events (AEs) were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.

11. Absolute Values for Hematology Parameters Over Time Including Week 48: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.

12. Absolute Values for Hematology Parameters: Erythrocyte Mean Corpuscular Volume [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated time points.

13. Absolute Values for Hematology Parameters: Erythrocytes [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated time points.

14. Absolute Values for Hematology Parameters: Hemoglobin [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points.

15. Absolute Values for Hematology Parameters: Hematocrit [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated time points.

16. Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

17. Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

18. Change From Baseline for Hematology Parameters: Erythrocytes [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

19. Change From Baseline for Hematology Parameters: Hematocrit [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

20. Change From Baseline for Hematology Parameters: Hemoglobin [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

21. Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points.

22. Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated time points.

23. Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated time points.

24. Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated time points.

25. Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated time points.

26. Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).

27. Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48.]

    The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to Division of AIDS (DAIDS) scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.

28. Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48]

    Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).

29. Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

30. Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

31. Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

32. Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

33. Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

34. Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

35. Change From Baseline Values for Fasting Lipid Panel Over Time Including Week 48 [Baseline (Day 1) and at Week 48]

    Blood samples were collected for the analysis of fasting lipid parameters- total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

36. Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48]

    Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

37. Change From Baseline Values in Urine Creatinine Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48]

    Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

38. Change From Baseline Values in Urine Phosphate Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48]

    Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

39. Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48 [Baseline (Day 1) and at Week 48]

    Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

40. Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48]

    Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.

41. Change From Baseline Values in Urine pH Over Time Including Week 48 [Baseline (Day 1) and at Weeks 4, 24 and 48]

    Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

42. Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

43. Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 [Baseline (Day 1) and at Week 48]

    Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Percentage change from Baseline is calculated as: value at Week 48 minus Baseline value divided by Baseline value multiplied by 100.

44. Number of Participants With Phenotypic Resistance Through Week 48 [At the time of CVF]

    Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.The CVF population comprised of all participants in ITT-E population who met CVF criteria.Phenotypic Resistance data for following drugs:CAB,dolutegravir(DTG),elvitegravir(EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI), atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),rito-navir(RTV),saquinavir(SQV) and tipranavir(TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance(FC>clinical higher cutoff/biologic cutoff),partially sensitive(FC <=clinical higher cutoff and > clinical lower cutoff),sensitive(FC <= clinical lower cutoff/biologic cutoff).

45. Number of Participants With Genotypic Resistance Through Week 48 [At the time of CVF]

    Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.

46. Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

47. Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).

48. Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).

49. Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).

50. Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI.

51. Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).

52. Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48 [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).

53. Absolute Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48 [Baseline (Day 1) and at Week 48]

    Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).

54. Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

55. Plasma Trough Concentration (Ctrough) for CAB LA Evaluable [Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples will be collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK population includes all participants who received CAB and / or RPV and underwent PK sampling during the study, and provided CAB and /or RPV plasma concentration data.

56. Ctrough for RPV LA Evaluable [Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples will be collected at indicated time points for PK analysis of RPV LA.

57. Area Under the Curve (AUC) for CAB LA [Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41]

    AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for CAB LA.

58. AUC for RPV LA [Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41]

    AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for RPV LA.

59. Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41 [Week 41- 1 Week post dose]

    Blood samples will be collected at indicated time points for PK analysis of CAB LA.

60. Cmax in Plasma for RPV LA Evaluable at Week 41 [Week 41- 1 Week post dose]

    Blood samples will be collected at indicated time points for PK analysis of RPV LA.

61. Percentage of Participants With a Virologic Failure Using Snapshot Algorithm by Baseline Third Agent [Week 48]

    Percentage of participants with virologic failure endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA >=50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.

62. Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent [Week 48]

    Percentage of participants with HIV-1 RNA < 50copies/mL endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA <50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.

63. Number of Participants With Severity of Adverse Events by Baseline Third Agents [Up to Week 48]

    Severity of AEs were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.

64. Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST and CK to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

65. Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

66. Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

67. Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

68. Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

69. Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48 [Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48]

    Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

70. Change From Baseline Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48 [Baseline (Day 1) and at Week 48]

    Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

71. Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 [At the time of CVF]

    Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.

72. Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 [At the time of CVF]

    Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Phenotypic Resistance data for the following drugs: CAB, DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. Phenotypic resistance, partially sensitive, and Sensitive were defined based on FC value from Monogram as: resistance (FC>clinical higher cutoff/biologic cutoff), partially sensitive (FC <=clinical higher cutoff and > clinical lower cutoff), sensitive (FC <= clinical lower cutoff/biologic cutoff).

73. Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm [Week 5 and at Weeks 41 and 48]

    The PIN questionnaire explores the bother of pain at the injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCFwas used as primary method of analysis

74. Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm [Weeks 5, 41 and 48]

    The PIN questionnaire explores the bother of pain at the injection site and injection site reactions(ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCF was used as primary method of analysis

75. Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire [Baseline (Day 1) and at Weeks 24 and 48]

    The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% confidence interval (CI).Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

76. Change From Baseline in HIV Medication, MEDWO Using HATQoL [Baseline and at Weeks 24 and 48]

    The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=[100 divided by (20 minus 5)]*(MEDWO minus 5). A response of 1 in MEDWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

77. Change From Baseline in DISWO Using HATQoL [Baseline and at Weeks 24 and 48]

    The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (20 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

78. Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) [Baseline and at Weeks 24 and 48]

    The SF-12 questionnaire consists of 7 questions which measures the degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. The HRQoL using SF-12 for the total score, physical component summary (PCS) and the mental component summary (MCS) were assessed for the two treatment groups. Missing Total or the component scores was imputed using LOCF. The PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com). The higher the score, the better will be the health status. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

79. Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 [Baseline and at Weeks 4b, 24 and 44]

    The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants

80. Change in Treatment Satisfaction Over Time Using HIVTSQ Change (HIVTSQc) at Week 48 in Q4W Arm [Week 48]

    The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants

81. Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire [Baseline and at Weeks 8, 24 and 48]

    The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication will be analyzed.Items on the scale are rated as 1-5 scores:1:totally disagree,2:somewhat disagree,3:somewhat agree, 4:totally agree and 5:I don't know.Total score of the dimension is calculated as the mean of the recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:score:Total Score=(mean of the recoded items in the dimension minus1)divided by2*100.LOCF was used as primary method of analysis.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI.Baseline value is defined as the latest pre-treatment assessment with a non-missing value.Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value

82. Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm [Weeks 4b, 5, 40 and 41]

    The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.

83. Change From Baseline in Individual Item Scores of HIVTSQc at Weeks 4b, 24 and 44 [Baseline and Weeks 4b, 24 and 44]

    HIVTSQc is a 12 item questionnaire. The individual treatment change item scores on HIVTSQc scale are rated as +3 ('much more satisfied', 'much more convenient', 'much more flexible',etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). The higher the score, the greater the improvement in satisfaction with each aspect of treatment and the lower the score, the greater the deterioration in satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Other Outcome Measures

1. Number of Participants With Different Demographic Parameters for Inter-subject Variability [Upto Week 48]

   Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged 18 years or older (or ≥19 where required by local regulatory agencies), at the time of signing the informed consent.

• Must be on uninterrupted current regimen (either the initial or second ARV regimen) for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA ≥400 c/mL).

• Acceptable stable (initial or second) ARV regimens prior to Screening include 2 NRTIs plus: INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen);NNRTI (either the initial or second cART regimen);Boosted PI (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability) The addition, removal, or switch of a drug(s) that has been used to treat HIV based on antiretroviral properties of the drug constitutes a change in ART with the following limited exceptions: Historical changes in formulations of ART drugs or booster drugs will not constitute a change in ART regimen if the data support similar exposures and efficacy, and the change must have been at least 3 months prior to Screening; Historical perinatal use of an NRTI when given in addition to an ongoing HAART will not be considered a change in ART regimen; A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.

• Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening;

• Plasma HIV-1 RNA <50 c/mL at Screening;

• A female subjects is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies:

1. Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up; confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

2. Reproductive potential and agrees to the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, and until from 30 days prior to the first dose of study medication throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form. Eligible subjects or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of subjects who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.

• Subjects enrolled in France must be affiliated to, or a beneficiary of, a social security category.

• All subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.

Exclusion Criteria:

• Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement ≥50 c/mL

• Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 c/mL

• Any drug holiday during the window between initiating first HIV ART and 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns

• Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA measurement ≥400 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen)

• Abacavir/dolutegravir/lamivudine, (ABC/DTG/3TC) as current ART regimen

• A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART

• Subjects who are currently participating in or anticipate to be selected for any other interventional study

• Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study

• Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm^3

• Subjects with moderate to severe hepatic impairment

• Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the subjects ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject.

• Subjects determined by the Investigator to have a high risk of seizures, including subjects with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment

• All subjects will be screened for syphilis (rapid plasma reagin [RPR]). Subjects with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Subjects with a serofast RPR result (persistence of a reactive nontreponemal syphilis test) despite history of adequate therapy and no evidence of re-exposure may enrol after consultation with the Medical Monitor. Subjects with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis

• Subjects who, in the investigator's judgment, pose a significant suicide risk. Subject's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk

• The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions

• Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:•Subjects positive for HBsAg are excluded;

• Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded

• Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted post Week 48, following consultation with the medical monitor) Subjects with HCV co-infection will be allowed entry into phase 3 studies if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on subjects with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility: Fib-4 score > 3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula:( Age x AST ) / ( Platelets x ( sqr [ ALT ])

• Unstable liver disease (as defined by any of the following: presence of ascites,encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices,or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)

• History of liver cirrhosis with or without hepatitis viral co-infection.

• Ongoing or clinically relevant pancreatitis

• Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease

• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomization

• Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the subject unable to receive study medication

• History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled

• Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325mg).

• Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International AIDS Society [IAS]-USA, 2015) by any historical resistance test result.

• Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result

• Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound

• Subject has estimated creatine clearance <50mL/min per 1.73m^2 via CKDEPI Method

• Alanine aminotransferase (ALT) ≥3 × ULN Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study;

• Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid,INH); anti-coagulation agents; Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Subjects using short term (e.g. ≤21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment.

• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening

• Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1

• Use of medications which are associated with Torsade de Pointes.

• Current or prior history of etravirine (ETR)

• Current use of tipranavir/ritonavir or fosamprenavir/ritonavir

• Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35294
2	GSK Investigational Site	Phoenix	Arizona	United States	85015
3	GSK Investigational Site	Bakersfield	California	United States	93301
4	GSK Investigational Site	Long Beach	California	United States	90813
5	GSK Investigational Site	Los Angeles	California	United States	90036
6	GSK Investigational Site	Los Angeles	California	United States	90069
7	GSK Investigational Site	Palm Springs	California	United States	92264
8	GSK Investigational Site	San Francisco	California	United States	94109
9	GSK Investigational Site	San Francisco	California	United States	94110
10	GSK Investigational Site	Denver	Colorado	United States	80246
11	GSK Investigational Site	Washington	District of Columbia	United States	20007
12	GSK Investigational Site	Washington	District of Columbia	United States	20009
13	GSK Investigational Site	Washington	District of Columbia	United States	20037
14	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
15	GSK Investigational Site	Fort Pierce	Florida	United States	34982
16	GSK Investigational Site	Sarasota	Florida	United States	34237
17	GSK Investigational Site	Vero Beach	Florida	United States	32960
18	GSK Investigational Site	Macon	Georgia	United States	31201
19	GSK Investigational Site	Chicago	Illinois	United States	60611
20	GSK Investigational Site	Boston	Massachusetts	United States	02129
21	GSK Investigational Site	Detroit	Michigan	United States	48202
22	GSK Investigational Site	Saint Louis	Missouri	United States	63110
23	GSK Investigational Site	Omaha	Nebraska	United States	68198
24	GSK Investigational Site	Buffalo	New York	United States	14201
25	GSK Investigational Site	New York	New York	United States	10016
26	GSK Investigational Site	New York	New York	United States	10029
27	GSK Investigational Site	Chapel Hill	North Carolina	United States	27599-7064
28	GSK Investigational Site	Charlotte	North Carolina	United States	28209
29	GSK Investigational Site	Cincinnati	Ohio	United States	45267-0405
30	GSK Investigational Site	Allentown	Pennsylvania	United States	18102
31	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15212
32	GSK Investigational Site	Austin	Texas	United States	78705
33	GSK Investigational Site	Dallas	Texas	United States	75246
34	GSK Investigational Site	Houston	Texas	United States	77098
35	GSK Investigational Site	Annandale	Virginia	United States	22003
36	GSK Investigational Site	Lynchburg	Virginia	United States	24501
37	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1405CKC
38	GSK Investigational Site	Ciudad de Buenos Aires	Buenos Aires	Argentina	C1202ABB
39	GSK Investigational Site	Rosario	Santa Fe	Argentina	2000
40	GSK Investigational Site	Buenos Aires		Argentina	1141
41	GSK Investigational Site	Darlinghurst, Sydney	New South Wales	Australia	2010
42	GSK Investigational Site	Darlinghurst	New South Wales	Australia	2010
43	GSK Investigational Site	Sydney	New South Wales	Australia	2010
44	GSK Investigational Site	Prahran	Victoria	Australia	3181
45	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 8L6
46	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1K2
47	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4E9
48	GSK Investigational Site	Montreal	Quebec	Canada	H4A 3J1
49	GSK Investigational Site	Regina	Saskatchewan	Canada	S4P 0W5
50	GSK Investigational Site	Québec		Canada	G1V 4G2
51	GSK Investigational Site	Montpellier Cedex 5		France	34295
52	GSK Investigational Site	Paris Cedex 10		France	75475
53	GSK Investigational Site	Paris Cedex 12		France	75571
54	GSK Investigational Site	Paris Cedex 13		France	75651
55	GSK Investigational Site	Paris		France	75018
56	GSK Investigational Site	Saint Denis Cedex 01		France	93205
57	GSK Investigational Site	Toulouse cedex 9		France	31059
58	GSK Investigational Site	Tourcoing cedex		France	59208
59	GSK Investigational Site	Muenchen	Bayern	Germany	80335
60	GSK Investigational Site	Frankfurt am Main	Hessen	Germany	60590
61	GSK Investigational Site	Frankfurt	Hessen	Germany	60596
62	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
63	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53127
64	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45122
65	GSK Investigational Site	Berlin		Germany	10439
66	GSK Investigational Site	Berlin		Germany	10787
67	GSK Investigational Site	Hamburg		Germany	20146
68	GSK Investigational Site	Hamburg		Germany	20246
69	GSK Investigational Site	Brescia	Lombardia	Italy	25123
70	GSK Investigational Site	Milano	Lombardia	Italy	20157
71	GSK Investigational Site	Busan		Korea, Republic of	49241
72	GSK Investigational Site	Daegu		Korea, Republic of	41944
73	GSK Investigational Site	Daejeon		Korea, Republic of	35015
74	GSK Investigational Site	Seoul		Korea, Republic of	03722
75	GSK Investigational Site	Seoul		Korea, Republic of	06591
76	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44280
77	GSK Investigational Site	Ekaterinburg		Russian Federation	620149
78	GSK Investigational Site	Kazan		Russian Federation	420061
79	GSK Investigational Site	Kemerovo		Russian Federation	650056
80	GSK Investigational Site	Krasnodar		Russian Federation	350015
81	GSK Investigational Site	Lipetsk		Russian Federation	398043
82	GSK Investigational Site	Moscow		Russian Federation	105275
83	GSK Investigational Site	Orel		Russian Federation	302040
84	GSK Investigational Site	Saratov		Russian Federation	410009
85	GSK Investigational Site	Smolensk		Russian Federation	214006
86	GSK Investigational Site	St. Petersburg		Russian Federation	190103
87	GSK Investigational Site	St. Petersburg		Russian Federation	193167
88	GSK Investigational Site	St. Petersburg		Russian Federation	196645
89	GSK Investigational Site	Toliyatti		Russian Federation	445846
90	GSK Investigational Site	Bloemfontein	Free State	South Africa	9301
91	GSK Investigational Site	Brandfort	Free State	South Africa	9400
92	GSK Investigational Site	Johannesburg	Gauteng	South Africa	2113
93	GSK Investigational Site	Durban	KwaZulu- Natal	South Africa	4001
94	GSK Investigational Site	Wentworth	KwaZulu- Natal	South Africa	4052
95	GSK Investigational Site	Middelburg	Mpumalanga	South Africa	1055
96	GSK Investigational Site	Durban		South Africa	4001
97	GSK Investigational Site	Observatory, Cape Town		South Africa	7925
98	GSK Investigational Site	Pretoria		South Africa	0087
99	GSK Investigational Site	Badalona		Spain	08916
100	GSK Investigational Site	Barcelona		Spain	08003
101	GSK Investigational Site	Barcelona		Spain	08035
102	GSK Investigational Site	Barcelona		Spain	08036
103	GSK Investigational Site	Córdoba		Spain	14004
104	GSK Investigational Site	Elche (Alicante)		Spain	03203
105	GSK Investigational Site	Madrid		Spain	28034
106	GSK Investigational Site	Madrid		Spain	28041
107	GSK Investigational Site	Madrid		Spain	28046
108	GSK Investigational Site	Malaga		Spain	29010
109	GSK Investigational Site	Santiago de Compostela		Spain	15706
110	GSK Investigational Site	Sevilla		Spain	41013
111	GSK Investigational Site	Valencia		Spain	46014
112	GSK Investigational Site	Vigo		Spain	36312
113	GSK Investigational Site	Göteborg		Sweden	SE-416 85
114	GSK Investigational Site	Stockholm		Sweden	SE-118 83
115	GSK Investigational Site	Stockholm		Sweden	SE-14186

Sponsors and Collaborators

• ViiV Healthcare
• Janssen Pharmaceuticals
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

• Study Protocol - Nov 2, 2017
• Statistical Analysis Plan - Jun 20, 2018

More Information

Publications

• Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02951052
• Other Study ID Numbers: 201585; 2016-001647-39
• First Posted: Nov 1, 2016
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ViiV Healthcare: Long-acting cabotegravir; Virologic failure; long-acting rilpivirine; Antiretroviral
• Additional relevant MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Rilpivirine; Cabotegravir

Study Results

Participant Flow

Recruitment Details	This was a phase III, randomized, open-label, active-controlled, multi-center, parallel-group, non-inferiority study to evaluate the antiviral activity and safety of two long-acting (LA) injectable drugs, cabotegravir (CAB) plus rilpivirine (RPV) when compared to current standard of care conducted in virologically suppressed human immunodeficiency.
Pre-assignment Detail	A total of 618 participants were enrolled in the study. Two randomized participants did not receive study treatment. A total of 616 participants contributed to the Intent-to-treat exposed Population and Safety Population. The results presented are based on Week 48 primary analysis.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Period Title: Overall Study
STARTED	308	308
COMPLETED	281	290
NOT COMPLETED	27	18

Baseline Characteristics

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART	Total
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA	Total of all reporting groups
Overall Participants	308	308	616
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	41.6 (9.99)	43.2 (11.43)	42.4 (10.76)
Sex: Female, Male (Count of Participants)
Female	99 32.1%	104 33.8%	203 33%
Male	209 67.9%	204 66.2%	413 67%
Race/Ethnicity, Customized (Count of Participants)
American Indian (AI) or Alaska Native (AN)	8 2.6%	8 2.6%	16 2.6%
Asian-Central South Asian Heritage	1 0.3%	0 0%	1 0.2%
Asian-Japanese/East/South-East Asian Heritage	21 6.8%	13 4.2%	34 5.5%
Black or African American	62 20.1%	77 25%	139 22.6%
Native Hawaiian or other Pacific Islander	0 0%	1 0.3%	1 0.2%
White	214 69.5%	207 67.2%	421 68.3%
AI or AN & Black/African American	0 0%	1 0.3%	1 0.2%
AI or AN & Black/African American & White	1 0.3%	1 0.3%	2 0.3%
Black/African American or White	1 0.3%	0 0%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
Description	Number of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the maintenance phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Count of Participants [Participants]	5 1.6%	3 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA >=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB - current ART) is not more than 6%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference in proportion
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -1.2 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).

2. Secondary Outcome

Title	Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Number of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Count of Participants [Participants]	285 92.5%	294 95.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in the proportion of participants with HIV-1 RNA<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference in proportion
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -6.7 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).

3. Secondary Outcome

Title	Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48
Description	Number of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Count of Participants [Participants]	286 92.9%	295 95.8%

4. Secondary Outcome

Title	Number of Participants With Confirmed Virologic Failure (CVF)
Description	The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. The outcome displays only visits during which at least one new CVF occurs. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Time Frame	Weeks 8, 12, 20, 24, 32 and 40

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 8	1 0.3%	0 0%
Week 12	2 0.6%	0 0%
Week 20	2 0.6%	2 0.6%
Week 24	3 1%	2 0.6%
Week 32	3 1%	3 1%
Week 40	3 1%	4 1.3%

5. Secondary Outcome

Title	Absolute Values for Plasma HIV-1 RNA at Week 48
Description	Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	265	292
Mean (Standard Deviation) [log10 copies/mL]	1.505 (0.0470)	1.518 (0.1123)

6. Secondary Outcome

Title	Change From Baseline Values for Plasma HIV-1 RNA
Description	Plasma for quantitative HIV-1 RNA were collected at indicated time points. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 - HIV-1 RNA(log 10) at Baseline.
Time Frame	Baseline and Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	265	292
Mean (Standard Deviation) [log10 copies/mL]	-0.013 (0.1940)	0.012 (0.1201)

7. Secondary Outcome

Title	Absolute Values for CD4+ Lymphocyte Count at Week 48
Description	Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	263	290
Mean (Standard Deviation) [Cells per cubic millimeter]	685.3 (262.97)	716.7 (292.85)

8. Secondary Outcome

Title	Change From Baseline Values for CD4+ Lymphocyte Count at Week 48
Description	Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value at Week 48 minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	263	290
Mean (Standard Deviation) [Cells per cubic millimeter]	9.9 (187.24)	19.4 (168.80)

9. Secondary Outcome

Title	Number of Participants With Disease Progression
Description	Disease progression was defined as HIV-associated conditions, acquired immunodeficiency syndrome (AIDS), and death through 48 Weeks. Data of participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Count of Participants [Participants]	8 2.6%	8 2.6%

10. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of IP during the maintenance phase of the study (on or after Day 1 visit). Participants will be assessed according to actual treatment received.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Any non-SAE	263 85.4%	117 38%
Any SAE	13 4.2%	14 4.5%

11. Secondary Outcome

Title	Number of Participants With Severity of Adverse Events
Description	Severity of adverse events (AEs) were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Grade 1	101 32.8%	115 37.3%
Grade 2	158 51.3%	81 26.3%
Grade 3	27 8.8%	19 6.2%
Grade 4	8 2.6%	4 1.3%
Grade 5	0 0%	1 0.3%

12. Secondary Outcome

Title	Absolute Values for Hematology Parameters Over Time Including Week 48: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Description	Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Basophils, Baseline, n=308, 307	0.021 (0.0147)	0.021 (0.0148)
Basophils, Week 4, n=299, 291	0.024 (0.0153)	0.023 (0.0161)
Basophils, Week 8, n=216, 294	0.023 (0.0188)	0.022 (0.0155)
Basophils, Week 12, n=293, 290	0.022 (0.0154)	0.022 (0.0157)
Basophils, Week 16, n=274, 292	0.022 (0.0147)	0.022 (0.0140)
Basophils, Week 20, n=273, 292	0.023 (0.0182)	0.024 (0.0195)
Basophils, Week 24, n=277, 292	0.023 (0.0139)	0.024 (0.0133)
Basophils, Week 28, n=266, 295	0.024 (0.0150)	0.023 (0.0138)
Basophils, Week 32, n=262, 283	0.025 (0.0171)	0.024 (0.0159)
Basophils, Week 36, n=260, 282	0.029 (0.0211)	0.028 (0.0190)
Basophils, Week 40, n=258, 280	0.035 (0.0266)	0.031 (0.0206)
Basophils, Week 44, n=258, 268	0.037 (0.0275)	0.033 (0.0222)
Basophils, Week 48, n=246, 274	0.040 (0.0253)	0.039 (0.0249)
Eosinophils, Baseline, n=308, 307	0.142 (0.1409)	0.140 (0.1538)
Eosinophils, Week 4, n=299, 291	0.168 (0.1587)	0.145 (0.1422)
Eosinophils, Week 8, n=216, 294	0.154 (0.1379)	0.131 (0.1333)
Eosinophils, Week 12, n=293, 290	0.142 (0.1172)	0.132 (0.1471)
Eosinophils, Week 16, n=274, 292	0.153 (0.1395)	0.131 (0.1584)
Eosinophils, Week 20, n=273, 292	0.152 (0.1480)	0.116 (0.1094)
Eosinophils, Week 24, n=277, 292	0.143 (0.1323)	0.121 (0.1337)
Eosinophils, Week 28, n=266, 295	0.144 (0.1266)	0.129 (0.1320)
Eosinophils, Week 32, n=262, 283	0.170 (0.1643)	0.131 (0.1319)
Eosinophils, Week 36, n=260, 282	0.150 (0.1403)	0.132 (0.1162)
Eosinophils, Week 40, n=258, 280	0.161 (0.1206)	0.132 (0.1124)
Eosinophils, Week 44, n=258, 268	0.175 (0.1471)	0.136 (0.1126)
Eosinophils, Week 48, n=246, 274	0.174 (0.1412)	0.140 (0.1265)
Leukocytes, Baseline, n=308, 307	5.87 (1.928)	5.65 (1.897)
Leukocytes, Week 4, n=300, 298	6.43 (2.154)	5.81 (1.733)
Leukocytes, Week 8, n=217, 301	6.14 (1.875)	5.64 (1.663)
Leukocytes, Week 12, n=294, 293	6.24 (1.876)	5.77 (1.751)
Leukocytes, Week 16, n=279, 295	6.27 (1.920)	5.82 (1.756)
Leukocytes, Week 20, n=276, 298	6.27 (1.947)	5.70 (1.721)
Leukocytes, Week 24, n=279, 294	6.18 (1.931)	5.78 (1.756)
Leukocytes, Week 28, n=268, 297	6.08 (1.949)	5.73 (1.637)
Leukocytes, Week 32, n=267, 288	6.30 (1.914)	5.73 (1.666)
Leukocytes, Week 36, n=264, 285	6.14 (1.831)	5.80 (1.968)
Leukocytes, Week 40, n=264, 286	6.24 (2.046)	5.74 (1.713)
Leukocytes, Week 44, n=269, 279	6.15 (1.884)	5.66 (1.745)
Leukocytes, Week 48, n=252, 282	6.01 (1.943)	5.62 (1.679)
Lymphocytes, Baseline, n=308, 307	1.943 (0.6073)	1.940 (0.6880)
Lymphocytes, Week 4, n=299, 291	2.127 (0.6942)	2.059 (0.6929)
Lymphocytes, Week 8, n=216, 294	1.995 (0.6347)	1.975 (0.6549)
Lymphocytes, Week 12, n=293, 290	1.984 (0.6428)	2.026 (0.6996)
Lymphocytes, Week 16, n=274, 292	2.057 (0.6840)	2.029 (0.6584)
Lymphocytes, Week 20, n=273, 292	2.035 (0.6140)	2.030 (0.6906)
Lymphocytes, Week 24, n=277, 292	2.016 (0.6523)	1.980 (0.6047)
Lymphocytes, Week 28, n=266, 295	2.049 (0.6960)	2.016 (0.6476)
Lymphocytes, Week 32, n=262, 283	2.020 (0.6157)	2.007 (0.6511)
Lymphocytes, Week 36, n=260, 282	1.960 (0.6009)	1.984 (0.6444)
Lymphocytes, Week 40, n=258, 280	1.994 (0.6149)	1.957 (0.6305)
Lymphocytes, Week 44, n=258, 268	2.016 (0.6457)	1.970 (0.6219)
Lymphocytes, Week 48, n=246, 274	1.900 (0.5725)	1.915 (0.6204)
Neutrophils, Baseline, n=308, 307	3.437 (1.6106)	3.209 (1.5748)
Neutrophils, Week 4, n=299, 291	3.708 (1.8763)	3.244 (1.3931)
Neutrophils, Week 8, n=216, 294	3.597 (1.6128)	3.190 (1.3370)
Neutrophils, Week 12, n=293, 290	3.724 (1.5751)	3.268 (1.4153)
Neutrophils, Week 16, n=274, 292	3.670 (1.6777)	3.308 (1.3870)
Neutrophils, Week 20, n=273, 292	3.707 (1.6532)	3.188 (1.3345)
Neutrophils, Week 24, n=277, 292	3.613 (1.5978)	3.289 (1.4381)
Neutrophils, Week 28, n=266, 295	3.528 (1.5464)	3.221 (1.2962)
Neutrophils, Week 32, n=262, 283	3.704 (1.6196)	3.228 (1.2909)
Neutrophils, Week 36, n=260, 282	3.629 (1.5688)	3.314 (1.6341)
Neutrophils, Week 40, n=258, 280	3.688 (1.7685)	3.280 (1.4190)
Neutrophils, Week 44, n=258, 268	3.571 (1.5425)	3.169 (1.4140)
Neutrophils, Week 48, n=246, 274	3.450 (1.5649)	3.172 (1.3627)
Monocytes, Baseline, n=308, 307	0.353 (0.1745)	0.339 (0.1596)
Monocytes, Week 4, n=299, 291	0.404 (0.1951)	0.367 (0.1694)
Monocytes, Week 8, n=216, 294	0.369 (0.1628)	0.358 (0.1875)
Monocytes, Week 12, n=293, 290	0.375 (0.1563)	0.342 (0.1693)
Monocytes, Week 16, n=274, 292	0.364 (0.1537)	0.345 (0.1645)
Monocytes, Week 20, n=273, 292	0.356 (0.1526)	0.342 (0.1632)
Monocytes, Week 24, n=277, 292	0.370 (0.1632)	0.341 (0.1632)
Monocytes, Week 28, n=266, 295	0.354 (0.1631)	0.333 (0.1592)
Monocytes, Week 32, n=262, 283	0.378 (0.1629)	0.351 (0.1801)
Monocytes, Week 36, n=260, 282	0.376 (0.1593)	0.366 (0.1824)
Monocytes, Week 40, n=258, 280	0.402 (0.1612)	0.359 (0.1823)
Monocytes, Week 44, n=258, 268	0.409 (0.1643)	0.388 (0.1795)
Monocytes, Week 48, n=246, 274	0.407 (0.1600)	0.384 (0.1742)
Platelets, Baseline, n=308, 308	231.1 (56.75)	232.9 (59.28)
Platelets, Week 4, n=300, 298	233.5 (55.09)	238.1 (61.98)
Platelets, Week 8, n=216, 298	227.4 (47.04)	234.0 (61.84)
Platelets, Week 12, n=294, 290	230.2 (57.32)	237.8 (64.42)
Platelets, Week 16, n=279, 294	226.1 (56.82)	236.4 (61.63)
Platelets, Week 20, n=274, 297	226.5 (58.11)	237.7 (61.51)
Platelets, Week 24, n=279, 292	224.9 (53.19)	239.8 (64.11)
Platelets, Week 28, n=268, 295	224.7 (54.15)	239.0 (62.32)
Platelets, Week 32, n=267, 289	226.5 (50.84)	239.3 (59.53)
Platelets, Week 36, n=267, 284	229.0 (53.90)	242.9 (66.12)
Platelets, Week 40, n=263, 288	230.1 (53.48)	240.8 (61.92)
Platelets, Week 44, n=270, 286	235.5 (55.80)	241.4 (61.73)
Platelets, Week 48, n=253, 281	230.5 (54.33)	240.2 (62.95)

13. Secondary Outcome

Title	Absolute Values for Hematology Parameters: Erythrocyte Mean Corpuscular Volume
Description	Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, n=308, 308	95.7 (7.97)	96.6 (9.35)
Week 4, n=300, 300	94.6 (6.88)	96.9 (9.31)
Week 8, n=218, 301	92.7 (5.76)	96.8 (9.25)
Week 12, n=294, 293	91.7 (5.69)	96.9 (9.34)
Week 16, n=280, 296	90.6 (5.48)	96.8 (9.64)
Week 20, n=276, 298	90.3 (5.37)	97.0 (9.63)
Week 24, n=279, 294	90.2 (5.44)	96.9 (9.75)
Week 28, n=268, 297	90.2 (5.68)	97.2 (9.77)
Week 32, n=268, 291	90.1 (5.55)	96.7 (9.36)
Week 36, n=267, 288	89.8 (5.64)	96.5 (9.08)
Week 40, n=264, 289	89.9 (5.57)	96.5 (9.05)
Week 44, n=273, 286	89.9 (5.52)	96.2 (9.08)
Week 48, n=255, 284	89.9 (5.58)	96.2 (9.38)

14. Secondary Outcome

Title	Absolute Values for Hematology Parameters: Erythrocytes
Description	Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, n=308, 308	4.55 (0.563)	4.49 (0.570)
Week 4, n=300, 300	4.59 (0.503)	4.45 (0.567)
Week 8, n=218, 301	4.68 (0.479)	4.49 (0.566)
Week 12, n=294, 293	4.79 (0.464)	4.51 (0.580)
Week 16, n=280, 296	4.84 (0.475)	4.48 (0.549)
Week 20, n=276, 298	4.86 (0.459)	4.48 (0.586)
Week 24, n=279, 294	4.86 (0.471)	4.48 (0.572)
Week 28, n=268, 297	4.85 (0.456)	4.47 (0.565)
Week 32, n=268, 291	4.84 (0.452)	4.48 (0.550)
Week 36, n=267, 288	4.81 (0.462)	4.49 (0.561)
Week 40, n=264, 289	4.84 (0.456)	4.49 (0.572)
Week 44, n=273, 286	4.86 (0.448)	4.49 (0.572)
Week 48, n=255, 284	4.81 (0.448)	4.50 (0.600)

15. Secondary Outcome

Title	Absolute Values for Hematology Parameters: Hemoglobin
Description	Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, n=308, 308	142.2 (17.24)	141.4 (16.29)
Week 4, n=300, 300	141.7 (16.30)	140.5 (16.44)
Week 8, n=218, 301	141.5 (16.08)	141.2 (16.51)
Week 12, n=294, 293	142.4 (15.90)	141.6 (16.62)
Week 16, n=280, 296	142.5 (16.19)	140.5 (15.81)
Week 20, n=276, 298	142.6 (15.52)	141.2 (16.62)
Week 24, n=279, 294	143.3 (15.66)	141.6 (16.18)
Week 28, n=268, 297	142.8 (16.05)	140.9 (15.89)
Week 32, n=268, 291	143.0 (15.42)	141.8 (15.81)
Week 36, n=267, 288	142.7 (16.31)	142.3 (15.72)
Week 40, n=264, 289	143.5 (15.80)	142.4 (15.90)
Week 44, n=273, 286	143.6 (15.66)	142.1 (16.38)
Week 48, n=255, 284	142.7 (15.93)	142.8 (16.34)

16. Secondary Outcome

Title	Absolute Values for Hematology Parameters: Hematocrit
Description	Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, n=308, 308	0.4333 (0.04804)	0.4305 (0.04454)
Week 4, n=300, 300	0.4325 (0.04570)	0.4283 (0.04548)
Week 8, n=218, 301	0.4327 (0.04570)	0.4310 (0.04580)
Week 12, n=294, 293	0.4379 (0.04483)	0.4338 (0.04640)
Week 16, n=280, 296	0.4369 (0.04626)	0.4304 (0.04418)
Week 20, n=276, 298	0.4378 (0.04476)	0.4312 (0.04755)
Week 24, n=279, 294	0.4376 (0.04589)	0.4312 (0.04595)
Week 28, n=268, 297	0.4364 (0.04607)	0.4308 (0.04555)
Week 32, n=268, 291	0.4350 (0.04311)	0.4299 (0.04431)
Week 36, n=267, 288	0.4311 (0.04462)	0.4295 (0.04348)
Week 40, n=264, 289	0.4342 (0.04381)	0.4300 (0.04449)
Week 44, n=273, 286	0.4357 (0.04288)	0.4282 (0.04472)
Week 48, n=255, 284	0.4318 (0.04438)	0.4286 (0.04465)

17. Secondary Outcome

Title	Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Description	Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Basophils, Week 4, n=299, 290	0.003 (0.0202)	0.003 (0.0185)
Basophils, Week 8, n=216, 293	0.003 (0.0204)	0.000 (0.0181)
Basophils, Week 12, n=293, 289	0.002 (0.0205)	0.001 (0.0197)
Basophils, Week 16, n=274, 291	0.001 (0.0186)	0.001 (0.0181)
Basophils, Week 20, n=273, 291	0.002 (0.0225)	0.002 (0.0212)
Basophils, Week 24, n=277, 291	0.002 (0.0169)	0.003 (0.0167)
Basophils, Week 28, n=266, 294	0.003 (0.0200)	0.002 (0.0181)
Basophils, Week 32, n=262, 282	0.005 (0.0199)	0.003 (0.0189)
Basophils, Week 36, n=260, 281	0.009 (0.0231)	0.007 (0.0217)
Basophils, Week 40, n=258, 279	0.014 (0.0292)	0.011 (0.0233)
Basophils, Week 44, n=258, 267	0.017 (0.0283)	0.012 (0.0239)
Basophils, Week 48, n=246, 273	0.019 (0.0273)	0.018 (0.0263)
Eosinophils, Week 4, n=299, 290	0.026 (0.1394)	0.009 (0.1409)
Eosinophils, Week 8, n=216, 293	0.015 (0.1278)	-0.008 (0.1319)
Eosinophils, Week 12, n=293, 289	-0.003 (0.1155)	-0.010 (0.1533)
Eosinophils, Week 16, n=274, 291	0.009 (0.1246)	-0.011 (0.1759)
Eosinophils, Week 20, n=273, 291	0.009 (0.1410)	-0.027 (0.1352)
Eosinophils, Week 24, n=277, 291	0.002 (0.1228)	-0.021 (0.1490)
Eosinophils, Week 28, n=266, 294	-0.002 (0.1298)	-0.011 (0.1387)
Eosinophils, Week 32, n=262, 282	0.022 (0.1629)	-0.012 (0.1511)
Eosinophils, Week 36, n=260, 281	0.002 (0.1413)	-0.012 (0.1382)
Eosinophils, Week 40, n=258, 279	0.019 (0.1319)	-0.006 (0.1283)
Eosinophils, Week 44, n=258, 267	0.032 (0.1388)	-0.004 (0.1061)
Eosinophils, Week 48, n=246, 273	0.032 (0.1321)	0.002 (0.1253)
Leukocytes, Week 4, n=300, 297	0.54 (1.599)	0.13 (1.544)
Leukocytes, Week 8, n=217, 300	0.19 (1.579)	-0.02 (1.548)
Leukocytes, Week 12, n=294, 292	0.35 (1.743)	0.10 (1.571)
Leukocytes, Week 16, n=279, 294	0.34 (1.653)	0.17 (1.558)
Leukocytes, Week 20, n=276, 297	0.46 (1.565)	0.04 (1.529)
Leukocytes, Week 24, n=279, 293	0.32 (1.720)	0.10 (1.661)
Leukocytes, Week 28, n=268, 296	0.25 (1.651)	0.07 (1.471)
Leukocytes, Week 32, n=267, 287	0.43 (1.602)	0.07 (1.631)
Leukocytes, Week 36, n=264, 284	0.33 (1.699)	0.13 (1.821)
Leukocytes, Week 40, n=264, 285	0.35 (1.808)	0.12 (1.675)
Leukocytes, Week 44, n=269, 278	0.22 (1.581)	-0.03 (1.561)
Leukocytes, Week 48, n=252, 281	0.09 (1.646)	-0.06 (1.538)
Lymphocytes, Week 4, n=299, 290	0.174 (0.5185)	0.128 (0.5618)
Lymphocytes, Week 8, n=216, 293	0.068 (0.5319)	0.023 (0.5250)
Lymphocytes, Week 12, n=293, 289	0.033 (0.5073)	0.079 (0.5844)
Lymphocytes, Week 16, n=274, 291	0.114 (0.5596)	0.095 (0.5389)
Lymphocytes, Week 20, n=273, 291	0.071 (0.5274)	0.086 (0.5411)
Lymphocytes, Week 24, n=277, 291	0.079 (0.5408)	0.049 (0.4863)
Lymphocytes, Week 28, n=266, 294	0.101 (0.6133)	0.069 (0.6005)
Lymphocytes, Week 32, n=262, 282	0.063 (0.5392)	0.064 (0.5757)
Lymphocytes, Week 36, n=260, 281	0.008 (0.5333)	0.036 (0.5525)
Lymphocytes, Week 40, n=258, 279	0.020 (0.5171)	0.035 (0.5280)
Lymphocytes, Week 44, n=258, 267	0.045 (0.5430)	0.045 (0.5472)
Lymphocytes, Week 48, n=246, 273	-0.063 (0.5528)	-0.035 (0.5115)
Neutrophils, Week 4, n=299, 290	0.258 (1.5445)	0.004 (1.3601)
Neutrophils, Week 8, n=216, 293	0.080 (1.4401)	-0.031 (1.3599)
Neutrophils, Week 12, n=293, 289	0.283 (1.6227)	0.028 (1.3884)
Neutrophils, Week 16, n=274, 291	0.181 (1.5415)	0.080 (1.4451)
Neutrophils, Week 20, n=273, 291	0.341 (1.4475)	-0.019 (1.4228)
Neutrophils, Week 24, n=277, 291	0.175 (1.5883)	0.056 (1.5091)
Neutrophils, Week 28, n=266, 294	0.129 (1.4052)	-0.001 (1.3377)
Neutrophils, Week 32, n=262, 282	0.291 (1.6015)	0.008 (1.4430)
Neutrophils, Week 36, n=260, 281	0.289 (1.5702)	0.077 (1.6758)
Neutrophils, Week 40, n=258, 279	0.245 (1.6621)	0.075 (1.5336)
Neutrophils, Week 44, n=258, 267	0.063 (1.4874)	-0.105 (1.4587)
Neutrophils, Week 48, n=246, 273	0.009 (1.5413)	-0.066 (1.3969)
Monocytes, Week 4, n=299, 290	0.049 (0.1663)	0.030 (0.1270)
Monocytes Week 8, n=216, 293	0.014 (0.1433)	0.018 (0.1591)
Monocytes, Week 12, n=293, 289	0.018 (0.1553)	0.001 (0.1367)
Monocytes, Week 16, n=274, 291	0.005 (0.1588)	0.003 (0.1403)
Monocytes, Week 20, n=273, 291	0.003 (0.1527)	0.004 (0.1328)
Monocytes, Week 24, n=277, 291	0.012 (0.1484)	0.002 (0.1331)
Monocytes, Week 28, n=266, 294	0.001 (0.1548)	-0.004 (0.1343)
Monocytes, Week 32, n=262, 282	0.019 (0.1535)	0.011 (0.1585)
Monocytes, Week 36, n=260, 281	0.016 (0.1501)	0.024 (0.1551)
Monocytes, Week 40, n=258, 279	0.039 (0.1507)	0.020 (0.1550)
Monocytes, Week 44, n=258, 267	0.045 (0.1673)	0.045 (0.1539)
Monocytes, Week 48, n=246, 273	0.047 (0.1502)	0.039 (0.1499)
Platelets, Week 4, n=300, 298	1.8 (38.02)	4.3 (36.15)
Platelets, Week 8, n=216, 298	-5.5 (31.98)	0.7 (35.15)
Platelets, Week 12, n=294, 290	-0.8 (40.83)	5.5 (36.76)
Platelets, Week 16, n=279, 294	-5.2 (40.67)	4.3 (34.61)
Platelets, Week 20, n=274, 297	-3.7 (36.87)	5.5 (38.86)
Platelets, Week 24, n=279, 292	-4.7 (35.22)	6.7 (41.78)
Platelets, Week 28, n=268, 295	-5.3 (35.22)	5.4 (38.41)
Platelets, Week 32, n=267, 289	-2.6 (36.51)	6.5 (35.99)
Platelets, Week 36, n=267, 284	-1.2 (37.26)	9.8 (44.52)
Platelets, Week 40, n=263, 288	0.0 (40.74)	9.7 (39.91)
Platelets, Week 44, n=270, 286	4.5 (38.31)	9.2 (42.82)
Platelets, Week 48, n=253, 281	0.0 (38.63)	10.4 (41.75)

18. Secondary Outcome

Title	Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume
Description	Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=300, 300	-1.1 (2.71)	0.2 (1.82)
Week 8, n=218, 301	-3.0 (4.30)	0.1 (1.76)
Week 12, n=294, 293	-3.9 (5.23)	0.2 (2.08)
Week 16, n=280, 296	-4.9 (5.86)	0.2 (2.42)
Week 20, n=276, 298	-5.3 (5.98)	0.3 (2.88)
Week 24, n=279, 294	-5.4 (5.97)	0.3 (3.24)
Week 28, n=268, 297	-5.5 (6.11)	0.4 (3.46)
Week 32, n=268, 291	-5.5 (6.10)	0.1 (3.47)
Week 36, n=267, 288	-5.8 (6.24)	-0.0 (3.69)
Week 40, n=264, 289	-5.6 (6.21)	-0.1 (3.62)
Week 44, n=273, 286	-5.8 (6.33)	-0.3 (3.68)
Week 48, n=255, 284	-5.7 (6.76)	-0.4 (3.57)

19. Secondary Outcome

Title	Change From Baseline for Hematology Parameters: Erythrocytes
Description	Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=300, 300	0.04 (0.255)	-0.03 (0.226)
Week 8, n=218, 301	0.14 (0.331)	-0.01 (0.249)
Week 12, n=294, 293	0.23 (0.374)	0.01 (0.252)
Week 16, n=280, 296	0.28 (0.380)	-0.01 (0.256)
Week 20, n=276, 298	0.30 (0.408)	-0.01 (0.273)
Week 24, n=279, 294	0.32 (0.397)	-0.01 (0.246)
Week 28, n=268, 297	0.28 (0.386)	-0.01 (0.246)
Week 32, n=268, 291	0.29 (0.393)	-0.01 (0.261)
Week 36, n=267, 288	0.26 (0.401)	-0.01 (0.259)
Week 40, n=264, 289	0.27 (0.396)	-0.01 (0.260)
Week 44, n=273, 286	0.31 (0.391)	-0.01 (0.264)
Week 48, n=255, 284	0.25 (0.394)	-0.01 (0.262)

20. Secondary Outcome

Title	Change From Baseline for Hematology Parameters: Hematocrit
Description	Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=300, 300	-0.0003 (0.02236)	-0.0023 (0.02194)
Week 8, n=218, 301	0.0007 (0.02613)	-0.0005 (0.02330)
Week 12, n=294, 293	0.0042 (0.02607)	0.0020 (0.02408)
Week 16, n=280, 296	0.0038 (0.02509)	-0.0007 (0.02513)
Week 20, n=276, 298	0.0043 (0.02742)	0.0002 (0.02613)
Week 24, n=279, 294	0.0052 (0.02790)	0.0002 (0.02576)
Week 28, n=268, 297	0.0023 (0.02699)	0.0002 (0.02603)
Week 32, n=268, 291	0.0022 (0.02872)	-0.0011 (0.02916)
Week 36, n=267, 288	-0.0012 (0.02793)	-0.0011 (0.02797)
Week 40, n=264, 289	-0.0001 (0.02741)	-0.0011 (0.02781)
Week 44, n=273, 286	0.0031 (0.02896)	-0.0025 (0.02814)
Week 48, n=255, 284	-0.0021 (0.02717)	-0.0031 (0.02700)

21. Secondary Outcome

Title	Change From Baseline for Hematology Parameters: Hemoglobin
Description	Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=300, 300	-0.4 (6.91)	-1.0 (6.73)
Week 8, n=218, 301	-0.4 (8.18)	-0.6 (7.33)
Week 12, n=294, 293	0.0 (8.14)	-0.3 (7.52)
Week 16, n=280, 296	0.4 (8.22)	-1.2 (7.75)
Week 20, n=276, 298	0.3 (8.60)	-0.5 (8.55)
Week 24, n=279, 294	1.2 (8.78)	-0.0 (8.46)
Week 28, n=268, 297	0.3 (8.49)	-0.6 (8.68)
Week 32, n=268, 291	0.9 (8.94)	0.2 (9.45)
Week 36, n=267, 288	0.7 (9.03)	0.8 (9.32)
Week 40, n=264, 289	0.8 (8.96)	0.7 (9.29)
Week 44, n=273, 286	1.7 (9.49)	0.6 (9.53)
Week 48, n=255, 284	0.2 (9.26)	0.9 (9.07)

22. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
ALT, Baseline (Day 1), n=308, 308	23.8 (13.47)	22.4 (12.90)
ALT, Week 4, n=301, 303	24.4 (15.60)	22.3 (11.10)
ALT, Week 8, n=229, 303	24.0 (16.85)	24.0 (29.86)
ALT, Week 12, n=295, 299	29.0 (114.25)	22.7 (13.48)
ALT, Week 16, n=284, 298	23.7 (22.32)	21.8 (11.31)
ALT, Week 20, n=277, 302	23.1 (22.49)	21.2 (10.50)
ALT, Week 24, n=284, 299	26.3 (62.05)	21.6 (12.64)
ALT, Week 28, n=267, 296	21.1 (12.13)	22.1 (14.62)
ALT, Week 32, n=275, 294	21.8 (12.56)	21.8 (12.09)
ALT, Week 36, n=273, 292	23.2 (24.94)	22.3 (12.17)
ALT, Week 40, n=270, 293	24.5 (37.39)	22.1 (12.78)
ALT, Week 44, n=275, 293	21.6 (13.10)	22.1 (13.67)
ALT, Week 48, n=265, 292	21.8 (13.54)	21.7 (11.08)
ALP, Baseline (Day 1), n=308, 308	76.6 (28.20)	77.5 (26.77)
ALP, Week 4, n=301, 303	70.4 (22.75)	75.7 (25.58)
ALP, Week 8, n=229, 303	68.9 (21.98)	78.8 (32.40)
ALP, Week 12, n=295, 299	68.9 (24.79)	78.6 (28.87)
ALP, Week 16, n=284, 298	67.9 (19.76)	77.3 (27.21)
ALP, Week 20, n=277, 302	67.6 (18.72)	76.7 (25.48)
ALP, Week 24, n=284, 299	68.1 (19.15)	77.5 (26.36)
ALP, Week 28, n=267, 296	67.6 (18.89)	77.2 (26.72)
ALP, Week 32, n=275, 294	66.6 (19.14)	75.8 (25.56)
ALP, Week 36, n=273, 292	66.8 (20.68)	76.4 (25.93)
ALP, Week 40, n=270, 293	66.2 (17.58)	76.2 (26.08)
ALP, Week 44, n=275, 293	66.1 (18.34)	76.8 (25.82)
ALP, Week 48, n=265, 292	66.5 (18.84)	77.1 (26.39)
AST, Baseline (Day 1), n=308, 308	23.9 (11.31)	22.5 (10.21)
AST, Week 4, n=301, 303	23.2 (11.77)	22.7 (10.93)
AST, Week 8, n=229, 303	24.3 (19.49)	22.5 (12.31)
AST, Week 12, n=295, 299	26.1 (64.69)	23.2 (10.61)
AST, Week 16, n=284, 298	24.1 (18.20)	22.5 (8.59)
AST, Week 20, n=277, 302	23.5 (15.23)	22.0 (6.83)
AST, Week 24, n=284, 298	24.2 (22.89)	22.5 (9.30)
AST, Week 28, n=267, 296	22.2 (8.72)	22.9 (9.61)
AST, Week 32, n=275, 294	22.8 (13.71)	23.2 (12.32)
AST, Week 36, n=273, 292	23.0 (11.27)	22.6 (7.18)
AST, Week 40, n=270, 293	23.8 (14.96)	22.5 (7.79)
AST, Week 44, n=275, 293	22.9 (14.82)	22.6 (10.26)
AST Week 48, n=265, 292	22.9 (10.35)	23.2 (9.30)
CK, Baseline (Day 1), n=308, 308	196.6 (367.30)	160.8 (367.57)
CK, Week 4, n=301, 303	192.9 (437.09)	190.6 (472.57)
CK, Week 8, n=229, 303	275.9 (1064.72)	145.4 (141.19)
CK, Week 12, n=295, 299	200.7 (484.08)	177.0 (321.29)
CK, Week 16, n=284, 298	253.5 (849.45)	167.5 (286.90)
CK, Week 20, n=277, 302	228.4 (570.80)	144.5 (133.32)
CK, Week 24, n=284, 299	193.1 (444.27)	161.2 (241.73)
CK, Week 28, n=267, 296	168.8 (163.54)	182.7 (420.44)
CK, Week 32, n=275, 294	216.5 (593.10)	195.9 (489.99)
CK, Week 36, n=273, 292	186.4 (325.64)	150.7 (134.40)
CK, Week 40, n=270, 293	235.1 (624.03)	160.7 (179.64)
CK, Week 44, n=275, 293	245.5 (1189.35)	149.9 (148.23)
CK, Week 48, n=265, 292	198.8 (398.14)	179.0 (331.51)

23. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
Description	Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline (Day 1), n=308, 308	44.2 (3.12)	44.3 (3.19)
Week 4, n=301, 303	43.7 (2.88)	43.8 (2.87)
Week 8, n=229, 303	43.8 (3.06)	43.7 (3.17)
Week 12, n=295, 299	43.6 (2.99)	43.9 (3.12)
Week 16, n=284, 298	43.5 (2.77)	43.5 (3.12)
Week 20, n=277, 302	43.4 (2.72)	43.5 (3.07)
Week 24, n=284, 299	43.4 (2.74)	43.5 (3.02)
Week 28, n=267, 296	43.6 (2.85)	43.3 (3.07)
Week 32, n=275, 294	43.5 (2.83)	43.4 (3.25)
Week 36, n=273, 292	43.3 (2.82)	43.4 (3.07)
Week 40, n=270, 293	43.7 (2.72)	43.4 (3.04)
Week 44, n=275, 293	43.7 (2.78)	43.5 (3.02)
Week 48, n=265, 292	43.8 (2.74)	44.0 (2.92)

24. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Description	Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Bilirubin, Baseline (Day 1), n=308, 308	9.9 (9.71)	9.2 (6.39)
Bilirubin, Week 4, n=301, 303	9.1 (3.98)	8.9 (6.14)
Bilirubin, Week 8, n=229, 303	9.3 (4.05)	9.4 (9.06)
Bilirubin, Week 12, n=295, 299	9.3 (4.45)	9.3 (6.62)
Bilirubin, Week 16, n=284, 298	10.0 (10.71)	9.1 (6.28)
Bilirubin, Week 20, n=277, 302	9.7 (4.28)	9.3 (7.56)
Bilirubin, Week 24, n=284, 298	9.3 (3.90)	9.4 (8.38)
Bilirubin, Week 28, n=267, 296	9.8 (3.99)	9.1 (7.05)
Bilirubin, Week 32, n=275, 294	9.8 (4.36)	9.3 (7.05)
Bilirubin, Week 36, n=273, 292	9.3 (3.79)	9.2 (7.34)
Bilirubin, Week 40, n=270, 293	9.6 (4.07)	9.5 (9.04)
Bilirubin, Week 44, n=275, 293	9.6 (4.19)	9.7 (8.49)
Bilirubin, Week 48, n=265, 292	9.7 (4.24)	9.5 (6.36)
Direct bilirubin, Baseline (Day 1), n=308, 308	2.4 (1.35)	2.2 (1.25)
Direct bilirubin, Week 4, n=301, 303	2.3 (1.04)	2.3 (1.27)
Direct bilirubin, Week 8, n=229, 303	2.3 (1.08)	2.4 (3.96)
Direct bilirubin, Week 12, n=295, 299	2.2 (1.03)	2.3 (1.30)
Direct bilirubin, Week 16, n=284, 298	2.5 (4.98)	2.1 (1.08)
Direct bilirubin, Week 20, n=277, 302	2.2 (0.95)	2.0 (1.31)
Direct bilirubin, Week 24, n=284, 298	2.2 (0.99)	2.1 (1.26)
Direct bilirubin, Week 28, n=267, 296	2.1 (0.94)	2.0 (1.28)
Direct bilirubin, Week 32, n=275, 294	2.1 (1.00)	2.0 (1.22)
Direct bilirubin, Week 36, n=273, 292	2.1 (1.11)	2.1 (1.27)
Direct bilirubin, Week 40, n=270, 293	2.1 (1.08)	2.1 (1.37)
Direct bilirubin, Week 44, n=275, 293	2.2 (0.95)	2.2 (1.30)
Direct bilirubin, Week 48, n=265, 292	2.2 (0.92)	2.2 (1.23)
Creatinine, Baseline (Day 1), n=308, 308	79.05 (16.380)	77.83 (16.497)
Creatinine, Week 4, n=301, 301	80.17 (15.464)	79.47 (16.284)
Creatinine, Week 8, n=229, 303	78.79 (16.122)	79.22 (16.824)
Creatinine, Week 12, n=295, 299	78.65 (16.534)	79.50 (17.191)
Creatinine, Week 16, n=284, 298	78.72 (15.606)	79.51 (17.171)
Creatinine, Week 20, n=277, 302	79.75 (15.695)	79.62 (16.909)
Creatinine, Week 24, n=284, 298	80.15 (18.478)	79.05 (16.673)
Creatinine, Week 28, n=267, 296	80.42 (16.335)	79.35 (16.574)
Creatinine, Week 32, n=275, 294	79.65 (15.044)	79.69 (16.634)
Creatinine, Week 36, n=273, 292	79.73 (15.994)	79.34 (16.527)
Creatinine, Week 40, n=270, 293	80.28 (15.856)	79.42 (16.856)
Creatinine, Week 44, n=275, 293	79.98 (15.775)	79.16 (16.583)
Creatinine, Week 48, n=265, 292	80.77 (16.456)	78.65 (16.204)

25. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48
Description	Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
CO2, Baseline (Day 1), n=308, 308	22.7 (2.33)	22.6 (2.24)
CO2, Week 4, n=301, 303	23.7 (2.49)	23.3 (2.27)
CO2, Week 8, n=229, 303	23.1 (2.17)	23.2 (2.47)
CO2, Week 12, n=295, 299	23.2 (2.14)	23.0 (2.36)
CO2, Week 16, n=284, 298	22.9 (2.16)	23.0 (2.31)
CO2, Week 20, n=277, 302	22.9 (2.16)	22.9 (2.29)
CO2, Week 24, n=284, 298	22.9 (2.31)	22.8 (2.41)
CO2, Week 28, n=267, 296	22.7 (2.42)	22.7 (2.27)
CO2, Week 32, n=275, 294	22.6 (2.15)	22.8 (2.34)
CO2, Week 36, n=273, 292	22.8 (2.19)	23.0 (2.26)
CO2, Week 40, n=270, 293	23.1 (2.27)	23.0 (2.45)
CO2, Week 44, n=275, 293	23.0 (2.19)	23.2 (2.31)
CO2, Week 48, n=265, 292	22.7 (2.29)	22.9 (2.29)
Chloride, Baseline (Day 1), n=308, 308	103.8 (2.03)	103.8 (2.39)
Chloride, Week 4, n=301, 303	104.3 (2.13)	104.3 (2.22)
Chloride, Week 8, n=229, 303	104.3 (2.26)	104.2 (2.40)
Chloride, Week 12, n=295, 299	104.2 (2.27)	104.3 (2.24)
Chloride, Week 16, n=284, 298	104.5 (2.21)	104.5 (2.28)
Chloride, Week 20, n=277, 302	104.7 (2.41)	104.5 (2.38)
Chloride, Week 24, n=284, 299	104.5 (2.36)	104.7 (2.30)
Chloride, Week 28, n=267, 296	104.8 (2.19)	104.8 (2.36)
Chloride, Week 32, n=275, 294	104.7 (2.50)	104.7 (2.31)
Chloride, Week 36, n=273, 292	104.8 (2.18)	104.6 (2.36)
Chloride, Week 40, n=270, 293	104.7 (2.22)	104.6 (2.61)
Chloride, Week 44, n=275, 293	104.6 (2.10)	104.6 (2.27)
Chloride, Week 48, n=265, 292	104.4 (2.38)	104.1 (2.37)
Glucose, Baseline (Day 1), n=301, 299	5.00 (0.714)	5.17 (0.988)
Glucose, Week 4, n=216, 226	5.17 (0.747)	5.42 (1.250)
Glucose, Week 8, n=153, 218	5.16 (0.990)	5.35 (1.037)
Glucose, Week 12, n=206, 221	5.19 (0.965)	5.35 (1.091)
Glucose, Week 16, n=209, 216	5.22 (1.163)	5.36 (1.317)
Glucose, Week 20, n=194, 221	5.20 (0.736)	5.37 (1.209)
Glucose, Week 24, n=215, 229	5.24 (0.810)	5.35 (0.840)
Glucose, Week 28, n=190, 226	5.16 (0.697)	5.36 (0.876)
Glucose, Week 32, n=194, 219	5.33 (1.042)	5.45 (1.102)
Glucose, Week 36, n=191, 220	5.19 (0.777)	5.40 (1.507)
Glucose, Week 40, n=195, 218	5.30 (0.797)	5.44 (1.227)
Glucose, Week 44, n=193, 213	5.22 (0.887)	5.44 (1.317)
Glucose, Week 48, n=242, 277	5.08 (0.614)	5.22 (0.963)
Phosphate, Baseline (Day 1), n=308, 308	1.042 (0.1771)	1.051 (0.1722)
Phosphate, Week 4, n=301, 303	1.110 (0.1793)	1.066 (0.1773)
Phosphate, Week 8, n=229, 303	1.097 (0.1944)	1.042 (0.1843)
Phosphate, Week 12, n=295, 299	1.080 (0.1872)	1.062 (0.1922)
Phosphate, Week 16, n=284, 298	1.081 (0.1796)	1.052 (0.1724)
Phosphate, Week 20, n=277, 302	1.073 (0.1746)	1.061 (0.1873)
Phosphate, Week 24, n=284, 299	1.082 (0.1788)	1.057 (0.1849)
Phosphate, Week 28, n=267, 296	1.072 (0.1714)	1.053 (0.1741)
Phosphate, Week 32, n=275, 294	1.061 (0.1730)	1.054 (0.1761)
Phosphate, Week 36, n=273, 292	1.052 (0.1700)	1.049 (0.1798)
Phosphate, Week 40, n=270, 293	1.065 (0.1789)	1.046 (0.1763)
Phosphate, Week 44, n=275, 293	1.066 (0.1798)	1.052 (0.1902)
Phosphate, Week 48, n=265, 292	1.077 (0.1816)	1.052 (0.1834)
Potassium, Baseline (Day 1), n=308, 308	4.16 (0.281)	4.17 (0.314)
Potassium, Week 4, n=301, 303	4.21 (0.307)	4.28 (0.352)
Potassium, Week 8, n=229, 303	4.16 (0.296)	4.22 (0.393)
Potassium, Week 12, n=295, 299	4.19 (0.330)	4.24 (0.332)
Potassium, Week 16, n=284, 298	4.18 (0.316)	4.23 (0.321)
Potassium, Week 20, n=277, 302	4.19 (0.311)	4.21 (0.320)
Potassium, Week 24, n=284, 298	4.18 (0.287)	4.23 (0.337)
Potassium, Week 28, n=267, 296	4.19 (0.346)	4.24 (0.391)
Potassium, Week 32, n=275, 294	4.18 (0.368)	4.21 (0.341)
Potassium, Week 36, n=273, 292	4.19 (0.326)	4.23 (0.345)
Potassium, Week 40, n=270, 293	4.20 (0.301)	4.23 (0.322)
Potassium, Week 44, n=275, 293	4.21 (0.323)	4.23 (0.359)
Potassium, Week 48, n=265, 292	4.15 (0.271)	4.16 (0.331)
Sodium, Baseline (Day 1), n=308, 308	139.0 (1.91)	139.0 (1.76)
Sodium, Week 4, n=301, 303	139.3 (1.70)	139.1 (1.87)
Sodium, Week 8, n=229, 303	139.1 (1.98)	139.0 (1.80)
Sodium, Week 12, n=295, 299	139.2 (1.84)	139.2 (1.85)
Sodium, Week 16, n=284, 298	139.1 (1.98)	139.1 (1.96)
Sodium, Week 20, n=277, 302	139.2 (1.87)	139.3 (1.81)
Sodium, Week 24, n=284, 299	139.3 (1.88)	139.3 (1.96)
Sodium, Week 28, n=267, 296	139.5 (1.77)	139.2 (2.01)
Sodium, Week 32, n=275, 294	139.3 (1.75)	139.5 (1.84)
Sodium, Week 36, n=273, 292	139.4 (1.79)	139.5 (2.15)
Sodium, Week 40, n=270, 293	139.4 (1.93)	139.5 (1.97)
Sodium, Week 44, n=275, 293	139.4 (1.80)	139.5 (1.93)
Sodium, Week 48, n=265, 292	139.4 (1.94)	139.4 (1.83)
Urea, Baseline (Day 1), n=308, 308	5.23 (1.546)	5.22 (1.632)
Urea, Week 4, n=301, 303	5.24 (1.495)	5.28 (1.549)
Urea, Week 8, n=229, 303	5.32 (1.640)	5.22 (1.529)
Urea, Week 12, n=295, 299	5.38 (1.612)	5.30 (1.649)
Urea, Week 16, n=284, 298	5.30 (1.662)	5.41 (1.659)
Urea, Week 20, n=277, 302	5.37 (1.631)	5.33 (1.662)
Urea, Week 24, n=284, 299	5.49 (1.749)	5.36 (1.639)
Urea, Week 28, n=267, 296	5.39 (1.756)	5.24 (1.527)
Urea, Week 32, n=275, 294	5.44 (1.624)	5.29 (1.599)
Urea, Week 36, n=273, 292	5.26 (1.664)	5.20 (1.485)
Urea, Week 40, n=270, 293	5.47 (1.593)	5.30 (1.537)
Urea, Week 44, n=275, 293	5.37 (1.531)	5.26 (1.524)
Urea, Week 48, n=265, 292	5.48 (1.648)	5.21 (1.437)

26. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
Description	Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated time points.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, n=308, 308	30.5 (22.88)	30.8 (19.12)
Week 4, n=301, 303	35.3 (52.73)	32.3 (23.30)
Week 8, n=227, 303	30.6 (22.70)	31.9 (20.71)
Week 12, n=294, 297	33.2 (27.92)	30.0 (18.06)
Week 16, n=285, 299	33.8 (30.49)	33.9 (34.69)
Week 20, n=278, 302	31.0 (21.73)	31.6 (28.88)
Week 24, n=283, 299	33.1 (24.09)	33.8 (29.69)
Week 28, n=267, 297	32.9 (27.42)	33.1 (19.69)
Week 32, n=274, 294	35.7 (60.63)	33.8 (21.64)
Week 36, n=273, 292	36.2 (51.58)	31.6 (18.46)
Week 40, n=269, 293	35.7 (36.06)	31.4 (15.80)
Week 44, n=274, 293	33.3 (26.29)	33.3 (20.44)
Week 48, n=264, 290	34.3 (30.97)	32.4 (20.40)

27. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance
Description	Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, n=308, 308	100.5 (18.30)	101.1 (17.72)
Week 4, n=301, 301	98.7 (17.26)	98.9 (17.93)
Week 8, n=227, 303	100.1 (17.19)	99.5 (17.59)
Week 12, n=295, 297	100.9 (17.72)	99.2 (18.34)
Week 16, n=284, 297	100.5 (17.26)	99.0 (18.32)
Week 20, n=277, 302	99.4 (17.37)	98.7 (17.73)
Week 24, n=283, 298	98.9 (17.04)	98.9 (17.44)
Week 28, n=267, 296	98.5 (17.66)	99.0 (17.33)
Week 32, n=274, 294	99.1 (16.89)	98.4 (17.54)
Week 36, n=273, 292	99.0 (17.19)	98.6 (16.85)
Week 40, n=268, 293	98.5 (17.32)	98.5 (17.37)
Week 44, n=274, 293	98.2 (16.96)	99.0 (17.39)
Week 48, n=264, 291	97.6 (16.97)	99.3 (17.09)

28. Secondary Outcome

Title	Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48
Description	The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to Division of AIDS (DAIDS) scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48.

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Urine bilirubin,Baseline (Day 1),Trace, n=303, 301	0 0%	0 0%
Urine bilirubin, Baseline (Day 1), 1+, n=303, 301	6 1.9%	7 2.3%
Urine bilirubin, Baseline (Day 1), 2+, n=303, 301	0 0%	0 0%
Urine bilirubin, Baseline (Day 1), 3+, n=303, 301	0 0%	0 0%
Urine glucose, Baseline (Day 1), Trace, n=303, 301	1 0.3%	1 0.3%
Urine glucose, Baseline (Day 1), 1+, n=303, 301	0 0%	1 0.3%
Urine glucose, Baseline (Day 1), 2+, n=303, 301	0 0%	0 0%
Urine glucose, Baseline (Day 1), 3+, n=303, 301	0 0%	1 0.3%
Urine ketones, Baseline (Day 1), Trace, n=303, 301	16 5.2%	17 5.5%
Urine ketones, Baseline (Day 1), 1+, n=303, 301	4 1.3%	0 0%
Urine ketones, Baseline (Day 1), 2+, n=303, 301	2 0.6%	1 0.3%
Urine ketones, Baseline (Day 1), 3+, n=303, 301	0 0%	0 0%
Urine leukocyte esterase,Baseline,Trace,n=303,301	25 8.1%	18 5.8%
Urine leukocyte esterase, Baseline, 1+, n=303, 301	14 4.5%	16 5.2%
Urine leukocyte esterase, Baseline, 2+, n=303, 301	14 4.5%	8 2.6%
Urine leukocyte esterase, Baseline, 3+, n=303, 301	5 1.6%	5 1.6%
Urine nitrite, Baseline, positive, n=303, 301	11 3.6%	11 3.6%
Urine occult blood, Baseline, Trace, n=303, 301	19 6.2%	12 3.9%
Urine occult blood, Baseline, 1+, n=303, 301	8 2.6%	9 2.9%
Urine occult blood, Baseline, 2+, n=303, 301	7 2.3%	5 1.6%
Urine occult blood, Baseline, 3+, n=303, 301	5 1.6%	3 1%
Urine protein, Baseline, Trace, n=303, 301	14 4.5%	20 6.5%
Urine protein, Baseline, 1+, n=303, 301	6 1.9%	12 3.9%
Urine protein, Baseline, 2+, n=303, 301	0 0%	1 0.3%
Urine protein, Baseline, 3+, n=303, 301	0 0%	0 0%
Urine protein, Baseline, 4+, n=303, 301	0 0%	0 0%
Urine bilirubin, Week 4, Trace, n=303, 302	0 0%	0 0%
Urine bilirubin, Week 4, 1+, n=303, 302	9 2.9%	5 1.6%
Urine bilirubin, Week 4, 2+, n=303, 302	0 0%	0 0%
Urine bilirubin, Week 4, 3+, n=303, 302	0 0%	0 0%
Urine glucose, Week 4, Trace, n=303, 302	3 1%	2 0.6%
Urine glucose, Week 4, 1+, n=303, 302	1 0.3%	2 0.6%
Urine glucose, Week 4, 2+, n=303, 302	2 0.6%	0 0%
Urine glucose, Week 4, 3+, n=303, 302	0 0%	1 0.3%
Urine ketones, Week 4, Trace, n=303, 302	9 2.9%	15 4.9%
Urine ketones, Week 4, 1+, n=303, 302	0 0%	2 0.6%
Urine ketones, Week 4, 2+, n=303, 302	1 0.3%	1 0.3%
Urine ketones, Week 4, 3+, n=303, 302	0 0%	0 0%
Urine leukocyte esterase, Week 4, Trace,n=303, 302	25 8.1%	29 9.4%
Urine leukocyte esterase, Week 4, 1+, n=303, 302	14 4.5%	15 4.9%
Urine leukocyte esterase, Week 4, 2+, n=303, 302	14 4.5%	9 2.9%
Urine leukocyte esterase, Week 4, 3+, n=303, 302	3 1%	4 1.3%
Urine nitrite, Week 4, positive, n=303, 302	10 3.2%	12 3.9%
Urine occult blood, Week 4, Trace, n=303, 302	15 4.9%	18 5.8%
Urine occult blood, Week 4, 1+, n=303, 302	9 2.9%	10 3.2%
Urine occult blood, Week 4, 2+, n=303, 302	5 1.6%	5 1.6%
Urine occult blood, Week 4, 3+, n=303, 302	4 1.3%	3 1%
Urine protein, Week 4, Trace, n=303, 302	10 3.2%	13 4.2%
Urine protein, Week 4, 1+, n=303, 302	8 2.6%	7 2.3%
Urine protein, Week 4, 2+, n=303, 302	2 0.6%	4 1.3%
Urine protein, Week 4, 3+, n=303, 302	0 0%	0 0%
Urine protein, Week 4, 4+, n=303, 302	0 0%	0 0%
Urine bilirubin, Week 24, Trace, n=279, 298	0 0%	0 0%
Urine bilirubin, Week 24, 1+, n=279, 298	10 3.2%	13 4.2%
Urine bilirubin, Week 24, 2+, n=279, 298	0 0%	0 0%
Urine bilirubin, Week 24, 3+, n=279, 298	0 0%	0 0%
Urine glucose, Week 24, Trace, n=279, 298	0 0%	1 0.3%
Urine glucose, Week 24, 1+, n=279, 298	2 0.6%	0 0%
Urine glucose, Week 24, 2+, n=279, 298	0 0%	1 0.3%
Urine glucose, Week 24, 3+, n=279, 298	1 0.3%	1 0.3%
Urine ketones, Week 24, Trace, n=279, 298	16 5.2%	13 4.2%
Urine ketones, Week 24, 1+, n=279, 298	1 0.3%	1 0.3%
Urine ketones, Week 24, 2+, n=279, 298	0 0%	0 0%
Urine ketones, Week 24, 3+, n=279, 298	0 0%	0 0%
Urine leukocyte esterase,Week 24, Trace, n=279,298	22 7.1%	17 5.5%
Urine leukocyte esterase, Week 24, 1+, n=279, 298	14 4.5%	14 4.5%
Urine leukocyte esterase, Week 24, 2+, n=279, 298	6 1.9%	14 4.5%
Urine leukocyte esterase, Week 24, 3+, n=279, 298	3 1%	7 2.3%
Urine nitrite, Week 24, positive, n=279, 298	9 2.9%	10 3.2%
Urine occult blood, Week 24, Trace, n=279, 298	13 4.2%	10 3.2%
Urine occult blood, Week 24, 1+, n=279, 298	5 1.6%	6 1.9%
Urine occult blood, Week 24, 2+, n=279, 298	6 1.9%	4 1.3%
Urine occult blood, Week 24, 3+, n=279, 298	0 0%	6 1.9%
Urine protein, Week 24, Trace, n=279, 298	10 3.2%	21 6.8%
Urine protein, Week 24, 1+, n=279, 298	4 1.3%	12 3.9%
Urine protein, Week 24, 2+, n=279, 298	1 0.3%	3 1%
Urine protein, Week 24, 3+, n=279, 298	0 0%	0 0%
Urine protein, Week 24, 4+, n=279, 298	0 0%	0 0%
Urine bilirubin, Week 48, Trace, n=279, 290	0 0%	0 0%
Urine bilirubin, Week 48, 1+, n=279, 290	9 2.9%	8 2.6%
Urine bilirubin, Week 48, 2+, n=279, 290	1 0.3%	0 0%
Urine bilirubin, Week 48, 3+, n=279, 290	0 0%	0 0%
Urine glucose, Week 48, Trace, n=279, 290	0 0%	1 0.3%
Urine glucose, Week 48, 1+, n=279, 290	0 0%	2 0.6%
Urine glucose, Week 48, 2+, n=279, 290	1 0.3%	0 0%
Urine glucose, Week 48, 3+, n=279, 290	0 0%	2 0.6%
Urine ketones, Week 48, Trace, n=279, 290	13 4.2%	9 2.9%
Urine ketones, Week 48, 1+, n=279, 290	0 0%	0 0%
Urine ketones, Week 48, 2+, n=279, 290	0 0%	0 0%
Urine ketones, Week 48, 3+, n=279, 290	0 0%	0 0%
Urine leukocyte esterase, Week 48, Trace,n=279,290	24 7.8%	27 8.8%
Urine leukocyte esterase, Week 48, 1+, n=279, 290	13 4.2%	15 4.9%
Urine leukocyte esterase, Week 48, 2+, n=279, 290	7 2.3%	7 2.3%
Urine leukocyte esterase, Week 48, 3+, n=279, 290	5 1.6%	6 1.9%
Urine nitrite, Week 48, positive, n=279, 290	10 3.2%	6 1.9%
Urine occult blood, Week 48, Trace, n=279, 290	11 3.6%	12 3.9%
Urine occult blood, Week 48, 1+, n=279, 290	5 1.6%	5 1.6%
Urine occult blood, Week 48, 2+, n=279, 290	4 1.3%	4 1.3%
Urine occult blood, Week 48, 3+, n=279, 290	6 1.9%	0 0%
Urine protein, Week 48, Trace, n=279, 290	10 3.2%	15 4.9%
Urine protein, Week 48, 1+, n=279, 290	4 1.3%	6 1.9%
Urine protein, Week 48, 2+, n=279, 290	3 1%	3 1%
Urine protein, Week 48, 3+, n=279, 290	0 0%	0 0%
Urine protein, Week 48, 4+, n=279, 290	0 0%	1 0.3%

29. Secondary Outcome

Title	Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48
Description	Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Baseline, pH=5, n=303, 301	44 14.3%	42 13.6%
Baseline, pH=5.5, n=303, 301	78 25.3%	80 26%
Baseline, pH=6, n=303, 301	85 27.6%	72 23.4%
Baseline, pH=6.5, n=303, 301	47 15.3%	45 14.6%
Baseline, pH=7, n=303, 301	32 10.4%	34 11%
Baseline, pH=7.5, n=303, 301	12 3.9%	19 6.2%
Baseline, pH=8, n=303, 301	3 1%	7 2.3%
Baseline, pH=8.5, n=303, 301	0 0%	1 0.3%
Baseline, pH>9.0, n=303, 301	2 0.6%	1 0.3%
Week 4, pH=5, n=303, 302	41 13.3%	53 17.2%
Week 4, pH=5.5, n=303, 302	78 25.3%	93 30.2%
Week 4, pH=6, n=303, 302	73 23.7%	67 21.8%
Week 4, pH=6.5, n=303, 302	49 15.9%	41 13.3%
Week 4, pH=7, n=303, 302	38 12.3%	28 9.1%
Week 4, pH=7.5, n=303, 302	12 3.9%	14 4.5%
Week 4, pH=8, n=303, 302	8 2.6%	3 1%
Week 4, pH=8.5, n=303, 302	3 1%	2 0.6%
Week 4, pH>9.0, n=303, 302	1 0.3%	1 0.3%
Week 24, pH=5, n=279, 298	23 7.5%	26 8.4%
Week 24, pH=5.5, n=279, 298	85 27.6%	96 31.2%
Week 24, pH=6, n=279, 298	66 21.4%	67 21.8%
Week 24, pH=6.5, n=279, 298	44 14.3%	52 16.9%
Week 24, pH=7, n=279, 298	32 10.4%	31 10.1%
Week 24, pH=7.5, n=279, 298	16 5.2%	15 4.9%
Week 24, pH=8, n=279, 298	7 2.3%	8 2.6%
Week 24, pH=8.5, n=279, 298	2 0.6%	2 0.6%
Week 24, pH>9.0, n=279, 298	4 1.3%	1 0.3%
Week 48, pH=5, n=279, 290	45 14.6%	43 14%
Week 48, pH=5.5, n=279, 290	69 22.4%	83 26.9%
Week 48, pH=6, n=279, 290	61 19.8%	58 18.8%
Week 48, pH=6.5, n=279, 290	47 15.3%	48 15.6%
Week 48, pH=7, n=279, 290	31 10.1%	30 9.7%
Week 48, pH=7.5, n=279, 290	17 5.5%	17 5.5%
Week 48, pH=8, n=279, 290	6 1.9%	5 1.6%
Week 48, pH=8.5, n=279, 290	0 0%	4 1.3%
Week 48, pH>9.0, n=279, 290	3 1%	2 0.6%

30. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK
Description	Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
ALT, Week 4, n=301, 303	0.8 (13.98)	0.1 (9.65)
ALT, Week 8, n=229, 303	0.7 (15.35)	1.6 (29.98)
ALT, Week 12, n=295, 299	5.2 (113.34)	0.4 (11.60)
ALT, Week 16, n=284, 298	-0.1 (21.80)	-0.6 (10.14)
ALT, Week 20, n=277, 302	-0.8 (22.62)	-1.1 (10.86)
ALT, Week 24, n=284, 299	2.2 (61.65)	-0.6 (10.57)
ALT, Week 28, n=267, 296	-2.7 (11.14)	-0.2 (12.52)
ALT, Week 32, n=275, 294	-1.9 (14.44)	-0.5 (11.49)
ALT, Week 36, n=273, 292	-0.8 (23.51)	0.1 (10.95)
ALT, Week 40, n=270, 293	0.6 (36.29)	-0.2 (11.82)
ALT, Week 44, n=275, 293	-2.2 (13.97)	-0.2 (12.37)
ALT, Week 48, n=265, 292	-1.9 (13.43)	-0.6 (10.50)
ALP, Week 4, n=301, 303	-6.0 (12.74)	-2.2 (8.85)
ALP, Week 8, n=229, 303	-6.7 (16.59)	1.1 (20.99)
ALP, Week 12, n=295, 299	-8.0 (20.87)	0.9 (14.45)
ALP, Week 16, n=284, 298	-9.7 (19.47)	-0.5 (10.35)
ALP, Week 20, n=277, 302	-9.2 (19.05)	-1.0 (11.65)
ALP, Week 24, n=284, 299	-9.0 (19.02)	-0.1 (10.67)
ALP, Week 28, n=267, 296	-10.1 (19.08)	-0.2 (11.44)
ALP, Week 32, n=275, 294	-9.9 (19.10)	-1.7 (11.29)
ALP, Week 36, n=273, 292	-10.5 (20.41)	-1.1 (11.44)
ALP, Week 40, n=270, 293	-10.4 (20.71)	-1.1 (11.34)
ALP, Week 44, n=275, 293	-11.4 (20.64)	-0.7 (12.02)
ALP, Week 48, n=265, 292	-10.9 (23.27)	-0.3 (12.51)
AST, Week 4, n=301, 303	-0.3 (12.52)	0.2 (10.02)
AST, Week 8, n=229, 303	1.2 (19.73)	-0.1 (13.68)
AST, Week 12, n=295, 299	2.3 (65.03)	0.6 (8.82)
AST, Week 16, n=284, 298	0.1 (18.49)	-0.1 (9.71)
AST, Week 20, n=277, 302	-0.5 (17.02)	-0.6 (9.80)
AST, Week 24, n=284, 298	0.1 (24.12)	0.0 (9.57)
AST, Week 28, n=267, 296	-1.4 (8.77)	0.3 (11.19)
AST, Week 32, n=275, 294	-1.2 (16.08)	0.6 (13.40)
AST, Week 36, n=273, 292	-1.2 (12.95)	0.1 (9.61)
AST, Week 40, n=270, 293	-0.2 (17.27)	0.0 (10.64)
AST, Week 44, n=275, 293	-1.1 (16.51)	0.1 (11.09)
AST Week 48, n=265, 292	-1.0 (12.79)	0.7 (10.75)
CK, Week 4, n=301, 303	-0.1 (548.15)	30.8 (435.12)
CK, Week 8, n=229, 303	98.2 (1076.99)	-16.5 (344.96)
CK, Week 12, n=295, 299	6.0 (585.45)	14.9 (288.85)
CK, Week 16, n=284, 298	54.2 (882.23)	5.8 (411.52)
CK, Week 20, n=277, 302	31.2 (653.11)	-16.7 (363.30)
CK, Week 24, n=284, 299	-9.2 (538.95)	-0.7 (353.99)
CK, Week 28, n=267, 296	-1.9 (213.98)	20.8 (538.83)
CK, Week 32, n=275, 294	13.3 (699.60)	34.0 (597.29)
CK, Week 36, n=273, 292	-18.2 (476.64)	-10.8 (358.72)
CK, Week 40, n=270, 293	39.7 (704.18)	-0.3 (373.96)
CK, Week 44, n=275, 293	47.4 (1185.55)	-10.9 (350.64)
CK, Week 48, n=265, 292	-0.6 (528.71)	18.1 (463.49)

31. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
Description	Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=301, 303	-0.5 (2.60)	-0.5 (2.49)
Week 8, n=229, 303	-0.3 (2.76)	-0.7 (2.70)
Week 12, n=295, 299	-0.6 (2.72)	-0.4 (2.63)
Week 16, n=284, 298	-0.6 (2.78)	-0.8 (2.70)
Week 20, n=277, 302	-0.8 (2.78)	-0.8 (2.56)
Week 24, n=284, 299	-0.7 (2.69)	-0.8 (2.59)
Week 28, n=267, 296	-0.7 (2.60)	-1.0 (2.47)
Week 32, n=275, 294	-0.6 (2.78)	-1.0 (2.56)
Week 36, n=273, 292	-0.9 (2.71)	-0.9 (2.65)
Week 40, n=270, 293	-0.5 (2.53)	-1.0 (2.61)
Week 44, n=275, 293	-0.4 (2.58)	-0.8 (2.47)
Week 48, n=265, 292	-0.4 (2.64)	-0.4 (2.55)

32. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Description	Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Bilirubin, Week 4, n=301, 303	-0.8 (9.87)	-0.3 (4.17)
Bilirubin, Week 8, n=229, 303	-0.1 (6.92)	0.1 (7.66)
Bilirubin, Week 12, n=295, 299	-0.6 (10.23)	0.1 (4.56)
Bilirubin, Week 16, n=284, 298	0.2 (14.00)	-0.2 (4.12)
Bilirubin, Week 20, n=277, 302	-0.2 (10.04)	0.0 (6.10)
Bilirubin, Week 24, n=284, 298	-0.6 (9.90)	0.2 (5.90)
Bilirubin, Week 28, n=267, 296	0.0 (10.46)	-0.1 (4.76)
Bilirubin, Week 32, n=275, 294	-0.1 (10.36)	0.0 (4.94)
Bilirubin, Week 36, n=273, 292	-0.6 (10.39)	0.1 (4.55)
Bilirubin, Week 40, n=270, 293	-0.3 (10.61)	0.2 (6.28)
Bilirubin, Week 44, n=275, 293	-0.4 (10.11)	0.4 (5.24)
Bilirubin, Week 48, n=265, 292	-0.3 (10.57)	0.2 (3.91)
Direct bilirubin, Week 4, n=301, 303	-0.1 (1.48)	0.1 (1.20)
Direct bilirubin, Week 8, n=229, 303	-0.1 (1.42)	0.2 (3.96)
Direct bilirubin, Week 12, n=295, 299	-0.2 (1.61)	0.1 (1.21)
Direct bilirubin, Week 16, n=284, 298	0.1 (5.02)	-0.1 (1.12)
Direct bilirubin, Week 20, n=277, 302	-0.3 (1.52)	-0.2 (1.29)
Direct bilirubin, Week 24, n=284, 298	-0.2 (1.55)	-0.1 (1.24)
Direct bilirubin, Week 28, n=267, 296	-0.3 (1.55)	-0.2 (1.29)
Direct bilirubin, Week 32, n=275, 294	-0.3 (1.61)	-0.2 (1.24)
Direct bilirubin, Week 36, n=273, 292	-0.3 (1.70)	-0.1 (1.20)
Direct bilirubin, Week 40, n=270, 293	-0.3 (1.68)	-0.2 (1.18)
Direct bilirubin, Week 44, n=275, 293	-0.2 (1.55)	-0.1 (1.19)
Direct bilirubin, Week 48, n=265, 292	-0.2 (1.54)	0.0 (1.23)
Creatinine, Week 4, n=301, 301	1.15 (8.205)	1.80 (8.022)
Creatinine, Week 8, n=229, 303	-0.66 (9.042)	1.23 (7.560)
Creatinine, Week 12, n=295, 299	-0.38 (9.380)	1.71 (7.638)
Creatinine, Week 16, n=284, 298	-0.60 (9.225)	1.62 (8.169)
Creatinine, Week 20, n=277, 302	0.53 (9.390)	1.80 (8.454)
Creatinine, Week 24, n=284, 298	0.90 (12.494)	1.36 (8.038)
Creatinine, Week 28, n=267, 296	1.14 (10.998)	1.59 (8.303)
Creatinine, Week 32, n=275, 294	0.33 (10.102)	1.95 (8.331)
Creatinine, Week 36, n=273, 292	0.34 (10.585)	1.62 (7.891)
Creatinine, Week 40, n=270, 293	0.88 (9.986)	1.64 (8.318)
Creatinine, Week 44, n=275, 293	1.03 (11.253)	1.40 (8.008)
Creatinine, Week 48, n=265, 292	1.59 (11.253)	0.82 (7.846)

33. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48
Description	Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
CO2, Week 4, n=301, 303	1.0 (2.53)	0.7 (2.21)
CO2, Week 8, n=229, 303	0.4 (2.31)	0.6 (2.52)
CO2, Week 12, n=295, 299	0.5 (2.42)	0.3 (2.39)
CO2, Week 16, n=284, 298	0.3 (2.42)	0.5 (2.41)
CO2, Week 20, n=277, 302	0.2 (2.26)	0.3 (2.31)
CO2, Week 24, n=284, 298	0.2 (2.46)	0.2 (2.44)
CO2, Week 28, n=267, 296	0.1 (2.47)	0.1 (2.39)
CO2, Week 32, n=275, 294	0.0 (2.37)	0.2 (2.31)
CO2, Week 36, n=273, 292	0.2 (2.37)	0.3 (2.39)
CO2, Week 40, n=270, 293	0.5 (2.49)	0.4 (2.29)
CO2, Week 44, n=275, 293	0.5 (2.34)	0.5 (2.19)
CO2, Week 48, n=265, 292	0.1 (2.41)	0.2 (2.31)
Chloride, Week 4, n=301, 303	0.4 (2.05)	0.5 (2.13)
Chloride, Week 8, n=229, 303	0.3 (2.12)	0.5 (2.19)
Chloride, Week 12, n=295, 299	0.4 (2.30)	0.5 (2.25)
Chloride, Week 16, n=284, 298	0.6 (2.41)	0.8 (2.25)
Chloride, Week 20, n=277, 302	0.8 (2.32)	0.8 (2.38)
Chloride, Week 24, n=284, 299	0.6 (2.48)	0.9 (2.26)
Chloride, Week 28, n=267, 296	0.9 (2.21)	1.0 (2.55)
Chloride, Week 32, n=275, 294	0.8 (2.41)	0.9 (2.33)
Chloride, Week 36, n=273, 292	0.9 (2.18)	0.9 (2.48)
Chloride, Week 40, n=270, 293	0.8 (2.24)	0.8 (2.76)
Chloride, Week 44, n=275, 293	0.7 (2.20)	0.8 (2.28)
Chloride, Week 48, n=265, 292	0.5 (2.36)	0.3 (2.38)
Glucose, Week 4, n=218, 226	0.17 (0.721)	0.21 (0.900)
Glucose, Week 8, n=151, 213	0.22 (0.841)	0.22 (0.832)
Glucose, Week 12, n=204, 216	0.19 (0.855)	0.19 (0.974)
Glucose, Week 16, n=207, 211	0.23 (1.050)	0.27 (1.084)
Glucose, Week 20, n=192, 216	0.19 (0.712)	0.19 (0.961)
Glucose, Week 24, n=212, 224	0.23 (0.710)	0.16 (0.881)
Glucose, Week 28, n=188, 225	0.17 (0.793)	0.28 (0.903)
Glucose, Week 32, n=192, 213	0.35 (0.956)	0.27 (0.939)
Glucose, Week 36, n=190, 215	0.18 (0.803)	0.26 (1.070)
Glucose, Week 40, n=193, 213	0.27 (0.833)	0.25 (0.891)
Glucose, Week 44, n=193, 213	0.23 (0.895)	0.27 (0.898)
Glucose, Week 48, n=238, 274	0.04 (0.693)	0.02 (0.924)
Phosphate, Week 4, n=301, 303	0.066 (0.1666)	0.015 (0.1595)
Phosphate, Week 8, n=229, 303	0.062 (0.1862)	-0.006 (0.1609)
Phosphate, Week 12, n=295, 299	0.041 (0.1978)	0.013 (0.1742)
Phosphate, Week 16, n=284, 298	0.041 (0.2012)	0.003 (0.1640)
Phosphate, Week 20, n=277, 302	0.035 (0.1871)	0.010 (0.1839)
Phosphate, Week 24, n=284, 299	0.042 (0.1963)	0.006 (0.1845)
Phosphate, Week 28, n=267, 296	0.037 (0.1822)	0.004 (0.1823)
Phosphate, Week 32, n=275, 294	0.021 (0.1980)	0.005 (0.1886)
Phosphate, Week 36, n=273, 292	0.011 (0.1846)	-0.002 (0.1855)
Phosphate, Week 40, n=270, 293	0.024 (0.2035)	-0.004 (0.1736)
Phosphate, Week 44, n=275, 293	0.027 (0.1982)	0.004 (0.1811)
Phosphate, Week 48, n=265, 292	0.034 (0.2007)	0.003 (0.1741)
Potassium, Week 4, n=301, 303	0.05 (0.342)	0.11 (0.375)
Potassium, Week 8, n=229, 303	0.01 (0.311)	0.06 (0.393)
Potassium, Week 12, n=295, 299	0.04 (0.341)	0.08 (0.356)
Potassium, Week 16, n=284, 298	0.01 (0.341)	0.06 (0.340)
Potassium, Week 20, n=277, 302	0.04 (0.345)	0.05 (0.359)
Potassium, Week 24, n=284, 298	0.03 (0.325)	0.07 (0.337)
Potassium, Week 28, n=267, 296	0.04 (0.380)	0.07 (0.389)
Potassium, Week 32, n=275, 294	0.02 (0.390)	0.05 (0.347)
Potassium, Week 36, n=273, 292	0.03 (0.356)	0.07 (0.359)
Potassium, Week 40, n=270, 293	0.04 (0.344)	0.07 (0.350)
Potassium, Week 44, n=275, 293	0.06 (0.344)	0.07 (0.372)
Potassium, Week 48, n=265, 292	-0.02 (0.299)	0.00 (0.332)
Sodium, Week 4, n=301, 303	0.3 (1.84)	0.1 (1.99)
Sodium, Week 8, n=229, 303	0.2 (1.99)	-0.1 (1.92)
Sodium, Week 12, n=295, 299	0.2 (2.07)	0.2 (1.91)
Sodium, Week 16, n=284, 298	0.1 (2.18)	0.1 (2.06)
Sodium, Week 20, n=277, 302	0.3 (2.10)	0.3 (1.95)
Sodium, Week 24, n=284, 299	0.3 (2.07)	0.2 (1.95)
Sodium, Week 28, n=267, 296	0.5 (2.11)	0.2 (2.24)
Sodium, Week 32, n=275, 294	0.3 (2.05)	0.4 (1.89)
Sodium, Week 36, n=273, 292	0.5 (2.01)	0.5 (2.19)
Sodium, Week 40, n=270, 293	0.4 (2.02)	0.5 (2.07)
Sodium, Week 44, n=275, 293	0.5 (2.03)	0.5 (2.05)
Sodium, Week 48, n=265, 292	0.4 (2.20)	0.3 (1.95)
Urea, Week 4, n=301, 303	0.01 (1.369)	0.08 (1.334)
Urea, Week 8, n=229, 303	0.07 (1.453)	0.00 (1.363)
Urea, Week 12, n=295, 299	0.15 (1.409)	0.09 (1.381)
Urea, Week 16, n=284, 298	0.08 (1.387)	0.19 (1.496)
Urea, Week 20, n=277, 302	0.15 (1.399)	0.11 (1.461)
Urea, Week 24, n=284, 299	0.25 (1.420)	0.15 (1.311)
Urea, Week 28, n=267, 296	0.15 (1.524)	0.00 (1.439)
Urea, Week 32, n=275, 294	0.20 (1.511)	0.06 (1.415)
Urea, Week 36, n=273, 292	0.06 (1.420)	-0.02 (1.386)
Urea, Week 40, n=270, 293	0.19 (1.400)	0.09 (1.452)
Urea, Week 44, n=275, 293	0.13 (1.426)	0.02 (1.467)
Urea, Week 48, n=265, 292	0.24 (1.465)	-0.01 (1.312)

34. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
Description	Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=301, 303	5.2 (41.42)	1.5 (23.88)
Week 8, n=227, 303	1.2 (19.31)	1.0 (17.96)
Week 12, n=294, 297	2.7 (25.12)	-0.8 (18.59)
Week 16, n=285, 299	2.6 (24.79)	3.5 (31.03)
Week 20, n=278, 302	0.9 (15.65)	0.8 (28.95)
Week 24, n=283, 299	2.1 (20.79)	3.0 (23.85)
Week 28, n=267, 297	2.2 (24.93)	2.3 (18.96)
Week 32, n=274, 294	5.2 (57.44)	3.1 (21.31)
Week 36, n=273, 292	5.1 (49.92)	0.7 (17.39)
Week 40, n=269, 293	5.1 (33.58)	0.5 (17.60)
Week 44, n=274, 293	2.0 (22.57)	2.3 (21.13)
Week 48, n=264, 290	3.0 (28.26)	1.5 (19.00)

35. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance.
Description	Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=301, 301	-1.8 (9.51)	-2.3 (9.18)
Week 8, n=227, 303	0.4 (9.88)	-1.5 (8.06)
Week 12, n=295, 297	0.3 (10.28)	-1.9 (8.02)
Week 16, n=284, 297	0.4 (10.63)	-1.9 (8.69)
Week 20, n=277, 302	-1.0 (10.37)	-2.4 (8.55)
Week 24, n=283, 298	-1.0 (10.52)	-2.3 (8.76)
Week 28, n=267, 296	-1.8 (11.47)	-2.4 (8.93)
Week 32, n=274, 294	-1.2 (11.11)	-3.0 (8.94)
Week 36, n=273, 292	-1.2 (11.26)	-2.6 (8.52)
Week 40, n=268, 293	-1.7 (10.70)	-2.7 (9.10)
Week 44, n=274, 293	-2.1 (10.45)	-2.3 (8.74)
Week 48, n=264, 291	-2.5 (11.80)	-1.9 (8.50)

36. Secondary Outcome

Title	Change From Baseline Values for Fasting Lipid Panel Over Time Including Week 48
Description	Blood samples were collected for the analysis of fasting lipid parameters- total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Week 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Total cholesterol, Week 48, n=231, 242	0.08 (0.688)	-0.04 (0.665)
HDL cholesterol, Week 48, n=231, 242	0.040 (0.2702)	0.002 (0.2682)
LDL cholesterol, Week 48, n=224, 238	0.098 (0.6105)	-0.017 (0.5314)
Triglycerides, Week 48, n=231, 242	-0.159 (0.8670)	-0.033 (0.7844)

37. Secondary Outcome

Title	Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48
Description	Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Urine albumin/creatinine ratio, Week 4,n=210, 221	0.32 (3.948)	0.06 (6.383)
Urine albumin/creatinine ratio, Week 24,n=198, 208	-0.08 (3.360)	-0.11 (8.552)
Urine albumin/creatinine ratio, Week 48,n=191, 197	0.15 (6.049)	-0.14 (5.286)
Urine protein/creatinine, Week 4, n=234, 236	-0.66 (11.803)	1.85 (31.997)
Urine protein/creatinine, Week 24, n=208, 232	-2.49 (8.028)	1.67 (20.505)
Urine protein/creatinine, Week 48, n=206, 225	-1.72 (9.551)	6.70 (112.353)

38. Secondary Outcome

Title	Change From Baseline Values in Urine Creatinine Over Time Including Week 48
Description	Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=304, 302	-543.9 (8693.94)	-305.5 (8787.62)
Week 24, n=282, 297	-341.8 (9286.26)	-270.4 (8437.76)
Week 48, n=282, 291	-342.9 (8965.01)	-521.6 (7873.28)

39. Secondary Outcome

Title	Change From Baseline Values in Urine Phosphate Over Time Including Week 48
Description	Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=302, 300	-0.460 (15.2707)	1.483 (15.0378)
Week 24, n=281, 294	0.286 (16.1887)	0.640 (14.4201)
Week 48, n=280, 291	-0.369 (14.2441)	1.254 (15.6532)

40. Secondary Outcome

Title	Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48
Description	Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Week 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	275	284
Mean (Standard Deviation) [Nanomoles per liter]	-1.8913 (14.10125)	1.4289 (15.70559)

41. Secondary Outcome

Title	Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48
Description	Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=298, 295	-0.0009 (0.00800)	-0.0000 (0.00785)
Week 24, n=274, 291	-0.0008 (0.00784)	-0.0000 (0.00770)
Week 48, n=274, 283	-0.0009 (0.00772)	-0.0002 (0.00768)

42. Secondary Outcome

Title	Change From Baseline Values in Urine pH Over Time Including Week 48
Description	Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4, n=298, 295	0.08 (0.886)	-0.13 (0.935)
Week 24, n=274, 291	0.18 (1.021)	0.01 (0.870)
Week 48, n=274, 283	0.09 (1.036)	-0.02 (0.951)

43. Secondary Outcome

Title	Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Count of Participants [Participants]	13 4.2%	5 1.6%

44. Secondary Outcome

Title	Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48
Description	Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Percentage change from Baseline is calculated as: value at Week 48 minus Baseline value divided by Baseline value multiplied by 100.
Time Frame	Baseline (Day 1) and at Week 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Cholesterol, Week 48, Overall, n=231, 242	3.25 (15.563)	0.13 (13.379)
HDL cholesterol, Week 48, Overall, n=231, 242	5.059 (20.5368)	2.132 (18.0473)
LDL cholesterol, Week 48, Overall, n=224, 238	6.762 (31.7209)	1.029 (19.4719)
Triglycerides, Week 48, Overall, n=231, 242	0.708 (43.5160)	8.203 (51.7632)

45. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance Through Week 48
Description	Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.The CVF population comprised of all participants in ITT-E population who met CVF criteria.Phenotypic Resistance data for following drugs:CAB,dolutegravir(DTG),elvitegravir(EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI), atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),rito-navir(RTV),saquinavir(SQV) and tipranavir(TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance(FC>clinical higher cutoff/biologic cutoff),partially sensitive(FC <=clinical higher cutoff and > clinical lower cutoff),sensitive(FC <= clinical lower cutoff/biologic cutoff).
Time Frame	At the time of CVF

Outcome Measure Data

Analysis Population Description

CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	3	4
INI, CAB, resistant, n=3, 4	1 0.3%	0 0%
INI, CAB, sensitive, n=3, 4	2 0.6%	4 1.3%
INI, DTG, resistant, n=3, 4	0 0%	0 0%
INI, DTG, partially sensitive, n=3, 4	0 0%	0 0%
INI, DTG, sensitive, n=3, 4	3 1%	4 1.3%
INI, EVG, resistant, n=3, 4	1 0.3%	0 0%
INI, EVG, sensitive, n=3, 4	2 0.6%	4 1.3%
INI, RAL, resistant, n=3, 4	1 0.3%	0 0%
INI, RAL, sensitive, n=3, 4	2 0.6%	4 1.3%
NNRTI, DLV, resistant, n=3, 3	2 0.6%	0 0%
NNRTI, DLV, sensitive, n=3, 3	1 0.3%	3 1%
NNRTI, EFV, resistant, n=3, 3	2 0.6%	0 0%
NNRTI, EFV, sensitive, n=3, 3	1 0.3%	3 1%
NNRTI, ETR, resistant, n=3, 3	0 0%	0 0%
NNRTI, ETR, partially sensitive, n=3, 3	2 0.6%	0 0%
NNRTI, ETR, sensitive, n=3, 3	1 0.3%	3 1%
NNRTI, NVP, resistant, n=3, 3	2 0.6%	0 0%
NNRTI, NVP, sensitive, n=3, 3	1 0.3%	3 1%
NNRTI, RPV, resistant, n=3, 3	3 1%	0 0%
NNRTI, RPV, sensitive, n=3, 3	0 0%	3 1%
NRTI, 3TC, resistant, n=3, 3	0 0%	1 0.3%
NRTI, 3TC, sensitive, n=3, 3	3 1%	2 0.6%
NRTI, ABC, resistant, n=3, 3	0 0%	0 0%
NRTI, ABC, partially sensitive, n=3, 3	0 0%	0 0%
NRTI, ABC, sensitive, n=3, 3	3 1%	3 1%
NRTI, FTC, resistant, n=3, 3	0 0%	1 0.3%
NRTI, FTC, sensitive, n=3, 3	3 1%	2 0.6%
NRTI, TDF, resistant, n=3, 3	0 0%	0 0%
NRTI, TDF, partially sensitive, n=3, 3	0 0%	0 0%
NRTI, TDF, sensitive, n=3, 3	3 1%	3 1%
NRTI, ZDV, resistant, n=3, 3	1 0.3%	0 0%
NRTI, ZDV, sensitive, n=3, 3	2 0.6%	3 1%
NRTI, d4T, resistant, n=3, 3	0 0%	0 0%
NRTI, d4T, sensitive, n=3, 3	3 1%	3 1%
NRTI, ddI, resistant, n=3, 3	0 0%	0 0%
NRTI, ddI, partially sensitive, n=3, 3	0 0%	0 0%
NRTI, ddI, sensitive, n=3, 3	3 1%	3 1%
PI, ATV, resistant, n=3, 3	0 0%	0 0%
PI, ATV, sensitive, n=3, 3	3 1%	3 1%
PI, DRV, resistant, n=3, 3	0 0%	0 0%
PI, DRV, partially sensitive, n=3, 3	0 0%	0 0%
PI, DRV, sensitive, n=3, 3	3 1%	3 1%
PI, FPV, resistant, n=3, 3	0 0%	0 0%
PI, FPV, partially sensitive, n=3, 3	0 0%	0 0%
PI, FPV, sensitive, n=3, 3	3 1%	3 1%
PI, IDV, resistant, n=3, 3	0 0%	0 0%
PI, IDV, sensitive, n=3, 3	3 1%	3 1%
PI, LPV, resistant, n=3, 3	0 0%	0 0%
PI, LPV, partially sensitive, n=3, 3	0 0%	0 0%
PI, LPV, sensitive, n=3, 3	3 1%	3 1%
PI, NFV, resistant, n=3, 3	0 0%	0 0%
PI, NFV, sensitive, n=3, 3	3 1%	3 1%
PI, RTV, resistant, n=3, 3	0 0%	0 0%
PI, RTV, sensitive, n=3, 3	3 1%	3 1%
PI, SQV, resistant, n=3, 3	0 0%	0 0%
PI, SQV, partially sensitive, n=3, 3	0 0%	0 0%
PI, SQV, sensitive, n=3, 3	3 1%	3 1%
PI, TPV, resistant, n=3, 3	0 0%	0 0%
PI, TPV, partially sensitive, n=3, 3	0 0%	0 0%
PI, TPV, sensitive, n=3, 3	3 1%	3 1%

46. Secondary Outcome

Title	Number of Participants With Genotypic Resistance Through Week 48
Description	Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.
Time Frame	At the time of CVF

Outcome Measure Data

Analysis Population Description

CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	3	4
INI, DTG, resistant	0 0%	0 0%
INI, DTG, resistance possible	0 0%	0 0%
INI, DTG, sensitive	3 1%	4 1.3%
INI, EVG, resistant	1 0.3%	0 0%
INI, EVG, resistance possible	0 0%	0 0%
INI, EVG, sensitive	2 0.6%	4 1.3%
INI, RAL, resistant	1 0.3%	0 0%
INI, RAL, resistance possible	0 0%	0 0%
INI, RAL, sensitive	2 0.6%	4 1.3%
NNRTI, DLV, resistant	0 0%	0 0%
NNRTI, DLV, resistance possible	0 0%	0 0%
NNRTI, DLV, sensitive	3 1%	4 1.3%
NNRTI, EFV, resistant	1 0.3%	1 0.3%
NNRTI, EFV, resistance possible	0 0%	0 0%
NNRTI, EFV, sensitive	2 0.6%	3 1%
NNRTI, ETR, resistant	0 0%	0 0%
NNRTI, ETR, resistance possible	2 0.6%	0 0%
NNRTI, ETR, sensitive	1 0.3%	4 1.3%
NNRTI, NVP, resistant	1 0.3%	1 0.3%
NNRTI, NVP, resistance possible	0 0%	0 0%
NNRTI, NVP, sensitive	2 0.6%	3 1%
NNRTI, RPV, resistant	3 1%	1 0.3%
NNRTI, RPV, resistance possible	0 0%	0 0%
NNRTI, RPV, sensitive	0 0%	3 1%
NRTI, 3TC, resistant	0 0%	2 0.6%
NNRTI, 3TC, resistance possible	0 0%	0 0%
NRTI, 3TC, sensitive	3 1%	2 0.6%
NRTI, ABC, resistant	0 0%	0 0%
NRTI, ABC, resistance possible	0 0%	0 0%
NRTI, ABC, sensitive	3 1%	4 1.3%
NRTI, FTC, resistant	0 0%	2 0.6%
NRTI, FTC, resistance possible	0 0%	0 0%
NRTI, FTC, sensitive	3 1%	2 0.6%
NRTI, TDF, resistant	0 0%	0 0%
NRTI, TDF, resistance possible	0 0%	0 0%
NRTI, TDF, sensitive	3 1%	4 1.3%
NRTI, ZDV, resistant	0 0%	0 0%
NRTI, ZDV, resistance possible	0 0%	0 0%
NRTI, ZDV, sensitive	3 1%	4 1.3%
NRTI, d4T, resistant	0 0%	0 0%
NRTI, d4T, resistance possible	0 0%	0 0%
NRTI, d4T, sensitive	3 1%	4 1.3%
NRTI, ddI, resistant	0 0%	0 0%
NRTI, ddI, resistance possible	0 0%	2 0.6%
NRTI, ddI, sensitive	3 1%	2 0.6%
PI, ATV, resistant	1 0.3%	0 0%
PI, ATV, resistance possible	0 0%	0 0%
PI, ATV, sensitive	2 0.6%	4 1.3%
PI, ATV/r, resistant	0 0%	0 0%
PI, ATV/r, resistance possible	1 0.3%	0 0%
PI, ATV/r, sensitive	2 0.6%	4 1.3%
PI, DRV/r, resistant	0 0%	0 0%
PI, DRV/r, resistance possible	0 0%	0 0%
PI, DRV/r, sensitive	3 1%	4 1.3%
PI, FPV/r, resistant	0 0%	0 0%
PI, FPV/r, resistance possible	0 0%	0 0%
PI, FPV/r, sensitive	3 1%	4 1.3%
PI, IDV/r, resistant	0 0%	0 0%
PI, IDV/r, resistance possible	0 0%	0 0%
PI, IDV/r, sensitive	3 1%	4 1.3%
PI, LPV/r, resistant	0 0%	0 0%
PI, LPV/r, resistance possible	0 0%	0 0%
PI, LPV/r, sensitive	3 1%	4 1.3%
PI, NFV, resistant	1 0.3%	0 0%
PI, NFV, resistance possible	0 0%	0 0%
PI, NFV, sensitive	2 0.6%	4 1.3%
PI, RTV, resistant	0 0%	0 0%
PI, RTV, resistance possible	0 0%	0 0%
PI, RTV, sensitive	3 1%	4 1.3%
PI, SQV/r, resistant	0 0%	0 0%
PI, SQV/r, resistance possible	0 0%	0 0%
PI, SQV/r, sensitive	3 1%	4 1.3%
PI, TPV/r, resistant	0 0%	0 0%
PI, TPV/r, resistance possible	0 0%	0 0%
PI, TPV/r, sensitive	3 1%	4 1.3%

47. Secondary Outcome

Title	Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Any AE, INI, n=102, 99	99 32.1%	68 22.1%
Any AE, NNRTI, n=155, 155	148 48.1%	116 37.7%
Any AE, PI, n=51, 54	47 15.3%	36 11.7%

48. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK
Description	Blood samples were collected for the analysis of clinical chemistry parameters to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, ALT, Baseline, n=51, 54	19.3 (11.23)	18.7 (9.13)
PI, ALT, Week 4, n=51, 53	28.7 (20.12)	19.8 (12.29)
PI, ALT, Week 8, n=34, 53	25.8 (19.28)	19.6 (10.43)
PI, ALT, Week 12, n=50, 52	24.7 (17.09)	20.1 (14.19)
PI, ALT, Week 16, n=48, 53	26.3 (19.89)	20.0 (12.04)
PI, ALT, Week 20, n=46, 53	24.9 (18.46)	19.0 (9.52)
PI, ALT, Week 24, n=47, 53	24.1 (13.75)	19.1 (10.02)
PI, ALT, Week 28, n=42, 53	22.0 (12.42)	19.4 (10.45)
PI, ALT, Week 32, n=45, 51	22.7 (15.18)	18.8 (8.18)
PI, ALT, Week 36, n=44, 50	22.3 (15.09)	20.7 (13.18)
PI, ALT, Week 40, n=42, 51	24.9 (19.63)	19.5 (13.46)
PI, ALT, Week 44, n=47, 51	23.2 (17.05)	19.3 (14.23)
PI, ALT, Week 48, n=43, 50	22.5 (13.28)	19.0 (8.52)
INI, ALT, Baseline, n=102, 99	24.8 (15.23)	21.2 (10.93)
INI, ALT, Week 4, n=99, 97	26.5 (18.35)	21.7 (10.09)
INI, ALT, Week 8, n=73, 98	28.4 (22.77)	26.8 (49.37)
INI, ALT, Week 12, n=99, 95	23.8 (14.21)	22.9 (16.05)
INI, ALT, Week 16, n=93, 96	23.2 (13.62)	21.2 (11.24)
INI, ALT, Week 20, n=93, 97	23.0 (15.29)	20.7 (9.83)
INI, ALT, Week 24, n=94, 95	25.7 (20.09)	21.0 (13.40)
INI, ALT, Week 28, n=89, 93	21.5 (13.06)	20.9 (14.10)
INI, ALT, Week 32, n=93, 95	22.5 (10.95)	21.1 (12.32)
INI, ALT, Week 36, n=94, 95	26.5 (38.41)	20.5 (9.38)
INI, ALT, Week 40, n=90, 95	30.2 (61.80)	20.6 (9.20)
INI, ALT, Week 44, n=91, 94	23.2 (15.03)	20.7 (10.01)
INI, ALT, Week 48, n=91, 95	24.4 (17.58)	20.3 (9.79)
NNRTI, ALT, Baseline, n=155, 155	24.6 (12.67)	24.4 (14.74)
NNRTI, ALT, Week 4, n=151, 153	21.6 (10.72)	23.7 (11.16)
NNRTI, ALT, Week 8, n=122, 152	20.8 (10.13)	23.7 (12.94)
NNRTI, ALT, Week 12, n=146, 152	33.9 (161.81)	23.6 (11.27)
NNRTI, ALT, Week 16, n=143, 149	23.2 (27.18)	22.8 (11.06)
NNRTI, ALT, Week 20, n=138, 152	22.6 (27.36)	22.3 (11.15)
NNRTI, ALT, Week 24, n=143, 151	27.4 (85.70)	22.9 (12.88)
NNRTI, ALT, Week 28, n=136, 150	20.6 (11.45)	23.8 (16.00)
NNRTI, ALT, Week 32, n=137, 148	21.1 (12.69)	23.4 (12.86)
NNRTI, ALT, Week 36, n=135, 147	21.2 (12.38)	24.1 (13.19)
NNRTI, ALT, Week 40, n=138, 147	20.8 (10.63)	23.9 (14.24)
NNRTI, ALT, Week 44, n=137, 148	20.0 (9.61)	23.9 (15.22)
NNRTI, ALT, Week 48, n=131, 147	19.8 (9.62)	23.5 (12.32)
PI, ALP, Baseline, n=51, 54	73.8 (24.90)	70.2 (19.56)
PI, ALP, Week 4, n=51, 53	70.4 (20.03)	67.7 (19.24)
PI, ALP, Week 8, n=34, 53	72.4 (34.86)	70.9 (23.18)
PI, ALP, Week 12, n=50, 52	68.2 (17.49)	71.6 (23.60)
PI, ALP, Week 16, n=48, 53	66.9 (15.70)	71.2 (21.50)
PI, ALP, Week 20, n=46, 53	67.7 (16.36)	70.8 (20.96)
PI, ALP, Week 24, n=47, 53	67.6 (16.14)	70.3 (19.23)
PI, ALP, Week 28, n=42, 53	67.3 (17.71)	73.7 (21.89)
PI, ALP, Week 32, n=45, 51	63.8 (16.09)	69.8 (21.44)
PI, ALP, Week 36, n=44, 50	64.3 (16.50)	71.7 (23.57)
PI, ALP, Week 40, n=42, 51	65.5 (13.63)	68.5 (19.55)
PI, ALP, Week 44, n=47, 51	63.0 (15.76)	69.1 (20.67)
PI, ALP, Week 48, n=43, 50	63.6 (14.22)	69.9 (18.94)
INI, ALP, Baseline, n=102, 99	66.3 (17.31)	64.9 (19.05)
INI, ALP, Week 4, n=99, 97	65.9 (17.25)	64.4 (18.77)
INI, ALP, Week 8, n=73, 98	64.0 (16.21)	69.7 (38.92)
INI, ALP, Week 12, n=99, 95	64.7 (16.33)	67.7 (27.73)
INI, ALP, Week 16, n=93, 96	65.3 (17.01)	64.4 (20.89)
INI, ALP, Week 20, n=93, 97	64.9 (16.80)	64.2 (19.58)
INI, ALP, Week 24, n=94, 95	65.0 (17.08)	64.4 (19.46)
INI, ALP, Week 28, n=89, 93	65.0 (15.81)	63.3 (18.76)
INI, ALP, Week 32, n=93, 95	64.4 (16.12)	62.3 (17.96)
INI, ALP, Week 36, n=94, 95	64.3 (18.15)	62.2 (18.12)
INI, ALP, Week 40, n=90, 95	65.1 (17.07)	62.2 (18.22)
INI, ALP, Week 44, n=91, 94	64.0 (16.71)	64.1 (19.31)
INI, ALP, Week 48, n=91, 95	65.1 (15.98)	63.0 (18.76)
NNRTI, ALP, Baseline, n=155, 155	84.4 (32.47)	88.1 (28.83)
NNRTI, ALP, Week 4, n=151, 153	73.4 (26.16)	85.6 (27.39)
NNRTI, ALP, Week 8, n=122, 152	70.9 (20.00)	87.4 (28.15)
NNRTI, ALP, Week 12, n=146, 152	72.0 (30.68)	87.8 (28.30)
NNRTI, ALP, Week 16, n=143, 149	69.9 (22.37)	87.7 (28.55)
NNRTI, ALP, Week 20, n=138, 152	69.3 (20.51)	86.7 (26.18)
NNRTI, ALP, Week 24, n=143, 151	70.2 (21.08)	88.3 (27.77)
NNRTI, ALP, Week 28, n=136, 150	69.3 (20.91)	87.0 (28.40)
NNRTI, ALP, Week 32, n=137, 148	69.1 (21.60)	86.5 (26.32)
NNRTI, ALP, Week 36, n=135, 147	69.3 (23.22)	87.1 (26.24)
NNRTI, ALP, Week 40, n=138, 147	67.1 (18.98)	87.8 (27.07)
NNRTI, ALP, Week 44, n=137, 148	68.4 (19.94)	87.5 (26.53)
NNRTI, ALP, Week 48, n=131, 147	68.5 (21.69)	88.6 (27.61)
PI, AST, Baseline, n=51, 54	19.7 (6.97)	20.1 (5.66)
PI, AST, Week 4, n=51, 53	23.5 (9.76)	22.5 (17.53)
PI, AST, Week 8, n=34, 53	23.4 (11.04)	20.0 (5.24)
PI, AST, Week 12, n=50, 52	22.5 (11.60)	21.8 (9.63)
PI, AST, Week 16, n=48, 53	23.7 (15.77)	22.0 (10.39)
PI, AST, Week 20, n=46, 53	24.1 (20.53)	20.6 (6.35)
PI, AST, Week 24, n=47, 53	21.5 (7.02)	21.7 (11.65)
PI, AST, Week 28, n=42, 53	22.9 (9.20)	22.0 (8.47)
PI, AST, Week 32, n=45, 51	23.0 (13.51)	20.3 (5.57)
PI, AST, Week 36, n=44, 50	21.5 (7.88)	21.8 (7.04)
PI, AST, Week 40, n=42, 51	25.1 (23.51)	20.5 (7.55)
PI, AST, Week 44, n=47, 51	21.6 (8.80)	21.4 (13.16)
PI, AST, Week 48, n=43, 50	21.6 (7.59)	22.2 (8.85)
INI, AST, Baseline, n=102, 99	24.5 (13.03)	22.2 (13.13)
INI, AST, Week 4, n=99, 97	24.5 (13.22)	22.0 (10.41)
INI, AST, Week 8, n=73, 98	26.8 (25.34)	23.6 (19.30)
INI, AST, Week 12, n=99, 95	23.2 (10.47)	23.2 (13.10)
INI, AST, Week 16, n=93, 96	22.5 (8.78)	22.5 (9.96)
INI, AST, Week 20, n=93, 97	22.8 (10.11)	21.4 (6.12)
INI, AST, Week 24, n=94, 95	24.4 (12.42)	22.0 (9.44)
INI, AST, Week 28, n=89, 93	21.3 (7.14)	21.6 (8.49)
INI, AST, Week 32, n=93, 95	22.2 (7.77)	21.6 (7.87)
INI, AST, Week 36, n=94, 95	23.9 (15.06)	21.1 (5.43)
INI, AST, Week 40, n=90, 95	25.4 (18.01)	21.8 (7.30)
INI, AST, Week 44, n=91, 94	25.6 (23.29)	21.4 (6.51)
INI, AST, Week 48, n=91, 95	24.9 (13.88)	22.4 (9.70)
NNRTI, AST, Baseline, n=155, 155	24.8 (10.99)	23.6 (9.16)
NNRTI, AST, Week 4, n=151, 153	22.2 (11.35)	23.2 (7.95)
NNRTI, AST, Week 8, n=122, 152	23.0 (17.16)	22.8 (7.19)
NNRTI, AST, Week 12, n=146, 152	29.4 (91.34)	23.6 (9.12)
NNRTI, AST, Week 16, n=143, 149	25.3 (22.91)	22.6 (6.80)
NNRTI, AST, Week 20, n=138, 152	23.8 (16.12)	22.9 (7.33)
NNRTI, AST, Week 24, n=143, 150	25.1 (30.40)	23.1 (8.25)
NNRTI, AST, Week 28, n=136, 150	22.6 (9.49)	24.0 (10.53)
NNRTI, AST, Week 32, n=137, 148	23.2 (16.69)	25.1 (15.63)
NNRTI, AST, Week 36, n=135, 147	22.8 (8.90)	23.9 (7.99)
NNRTI, AST, Week 40, n=138, 147	22.3 (7.66)	23.7 (8.01)
NNRTI, AST, Week 44, n=137, 148	21.7 (7.11)	23.8 (10.98)
NNRTI, AST, Week 48, n=131, 147	22.0 (7.86)	24.2 (9.16)
PI, CK, Baseline, n=51, 54	121.3 (173.52)	111.8 (66.03)
PI, CK, Week 4, n=51, 53	130.0 (94.61)	244.2 (908.06)
PI, CK, Week 8, n=34, 53	157.7 (174.37)	134.2 (179.01)
PI, CK, Week 12, n=50, 52	124.2 (71.36)	168.8 (406.86)
PI, CK, Week 16, n=48, 53	142.3 (197.96)	127.0 (82.59)
PI, CK, Week 20, n=46, 53	227.9 (689.65)	117.5 (76.83)
PI, CK, Week 24, n=47, 53	120.8 (72.63)	128.9 (85.38)
PI, CK, Week 28, n=42, 53	185.9 (237.49)	124.2 (96.15)
PI, CK, Week 32, n=45, 51	282.5 (959.49)	110.1 (58.84)
PI, CK, Week 36, n=44, 50	115.5 (81.36)	130.9 (95.59)
PI, CK, Week 40, n=42, 51	319.4 (1169.15)	109.9 (53.99)
PI, CK, Week 44, n=47, 51	117.2 (74.25)	114.4 (62.44)
PI, CK, Week 48, n=43, 50	123.5 (90.77)	183.1 (485.07)
INI, CK, Baseline, n=102, 99	257.9 (565.99)	214.3 (627.94)
INI, CK, Week 4, n=99, 97	225.9 (484.50)	193.6 (415.15)
INI, CK, Week 8, n=73, 98	306.8 (791.76)	158.0 (164.72)
INI, CK, Week 12, n=99, 95	242.5 (649.06)	195.3 (383.74)
INI, CK, Week 16, n=93, 96	198.6 (335.16)	216.4 (422.21)
INI, CK, Week 20, n=93, 97	200.9 (301.61)	158.8 (156.94)
INI, CK, Week 24, n=94, 95	202.1 (276.49)	178.8 (356.60)
INI, CK, Week 28, n=89, 93	151.1 (128.42)	192.6 (463.71)
INI, CK, Week 32, n=93, 95	182.2 (202.28)	175.1 (256.84)
INI, CK, Week 36, n=94, 95	190.7 (268.67)	153.8 (151.29)
INI, CK, Week 40, n=90, 95	286.9 (705.76)	178.2 (200.25)
INI, CK, Week 44, n=91, 94	457.7 (2054.68)	153.6 (139.48)
INI, CK, Week 48, n=91, 95	278.9 (651.96)	188.7 (339.93)
NNRTI, CK, Baseline, n=155, 155	180.9 (210.84)	143.8 (118.05)
NNRTI, CK, Week 4, n=151, 153	192.5 (472.95)	170.1 (226.58)
NNRTI, CK, Week 8, n=122, 152	290.4 (1322.89)	141.1 (106.01)
NNRTI, CK, Week 12, n=146, 152	198.5 (430.65)	168.5 (236.30)
NNRTI, CK, Week 16, n=143, 149	326.5 (1157.93)	150.4 (214.31)
NNRTI, CK, Week 20, n=138, 152	247.2 (661.97)	144.9 (131.72)
NNRTI, CK, Week 24, n=143, 151	210.9 (582.66)	161.5 (182.51)
NNRTI, CK, Week 28, n=136, 150	175.0 (156.46)	197.3 (460.97)
NNRTI, CK, Week 32, n=137, 148	218.0 (617.20)	238.8 (656.12)
NNRTI, CK, Week 36, n=135, 147	206.4 (401.19)	155.5 (134.30)
NNRTI, CK, Week 40, n=138, 147	175.6 (156.39)	166.9 (191.28)
NNRTI, CK, Week 44, n=137, 148	148.6 (94.67)	159.7 (171.66)
NNRTI, CK, Week 48, n=131, 147	167.8 (132.83)	171.3 (256.04)

49. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin
Description	Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Baseline, n=51, 54	43.9 (3.22)	44.2 (3.36)
PI, Week 4, n=51, 53	44.1 (2.90)	43.9 (2.92)
PI, Week 8, n=34, 53	44.6 (3.36)	44.1 (3.32)
PI, Week 12, n=50, 52	43.7 (3.25)	43.8 (3.56)
PI, Week 16, n=48, 53	43.8 (3.19)	43.4 (3.36)
PI, Week 20, n=46, 53	43.6 (2.70)	43.3 (3.57)
PI, Week 24, n=47, 53	43.5 (2.80)	43.3 (3.09)
PI, Week 28, n=42, 53	43.5 (2.74)	42.8 (3.43)
PI, Week 32, n=45, 51	43.2 (2.85)	43.7 (3.31)
PI, Week 36, n=44, 50	43.5 (2.87)	43.4 (3.02)
PI, Week 40, n=42, 51	44.2 (2.64)	43.9 (3.11)
PI, Week 44, n=47, 51	43.6 (2.58)	43.9 (3.03)
PI, Week 48, n=43, 50	43.9 (2.97)	44.5 (2.44)
INI, Baseline, n=102, 99	44.3 (3.08)	44.9 (3.21)
INI, Week 4, n=99, 97	43.9 (2.91)	43.8 (2.57)
INI, Week 8, n=73, 98	43.7 (3.07)	43.9 (3.10)
INI, Week 12, n=99, 95	44.1 (3.01)	44.3 (2.62)
INI, Week 16, n=93, 96	43.9 (2.77)	43.7 (2.76)
INI, Week 20, n=93, 97	43.6 (2.70)	44.1 (2.87)
INI, Week 24, n=94, 95	43.4 (3.03)	43.9 (3.00)
INI, Week 28, n=89, 93	44.0 (2.97)	43.9 (2.87)
INI, Week 32, n=93, 95	44.1 (2.87)	43.7 (2.89)
INI, Week 36, n=94, 95	43.6 (2.74)	43.7 (2.60)
INI, Week 40, n=90, 95	44.1 (2.79)	43.6 (2.70)
INI, Week 44, n=91, 94	43.6 (2.96)	43.8 (2.83)
INI, Week 48, n=91, 95	44.3 (2.58)	44.3 (2.73)
NNRTI, Baseline, n=155, 155	44.1 (3.11)	44.0 (3.10)
NNRTI, Week 4, n=151, 153	43.4 (2.83)	43.7 (3.04)
NNRTI, Week 8, n=122, 152	43.6 (2.96)	43.4 (3.16)
NNRTI, Week 12, n=146, 152	43.3 (2.86)	43.7 (3.25)
NNRTI, Week 16, n=143, 149	43.3 (2.61)	43.3 (3.27)
NNRTI, Week 20, n=138, 152	43.1 (2.75)	43.2 (2.98)
NNRTI, Week 24, n=143, 151	43.4 (2.54)	43.4 (3.01)
NNRTI, Week 28, n=136, 150	43.3 (2.78)	43.2 (3.03)
NNRTI, Week 32, n=137, 148	43.2 (2.74)	43.1 (3.43)
NNRTI, Week 36, n=135, 147	43.0 (2.86)	43.3 (3.37)
NNRTI, Week 40, n=138, 147	43.3 (2.66)	43.1 (3.20)
NNRTI, Week 44, n=137, 148	43.7 (2.74)	43.2 (3.13)
NNRTI, Week 48, n=131, 147	43.4 (2.73)	43.6 (3.14)

50. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Description	Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Bilirubin, Baseline, n=51, 54	18.3 (20.54)	13.9 (11.07)
PI, Bilirubin, Week 4, n=51, 53	9.3 (3.81)	14.4 (10.37)
PI, Bilirubin, Week 8, n=34, 53	8.9 (3.45)	14.2 (10.79)
PI, Bilirubin, Week 12, n=50, 52	8.1 (3.44)	15.6 (11.70)
PI, Bilirubin, Week 16, n=48, 53	8.7 (3.95)	14.7 (10.78)
PI, Bilirubin, Week 20, n=46, 53	9.3 (3.60)	15.6 (14.96)
PI, Bilirubin, Week 24, n=47, 53	9.5 (3.42)	16.8 (16.15)
PI, Bilirubin, Week 28, n=42, 53	9.4 (4.29)	15.0 (12.75)
PI, Bilirubin, Week 32, n=45, 51	9.7 (3.66)	17.1 (12.45)
PI, Bilirubin, Week 36, n=44, 50	8.3 (3.17)	16.0 (14.09)
PI, Bilirubin, Week 40, n=42, 51	9.2 (3.51)	17.9 (18.08)
PI, Bilirubin, Week 44, n=47, 51	9.5 (3.41)	18.1 (16.62)
PI, Bilirubin, Week 48, n=43, 50	9.3 (3.77)	16.7 (10.73)
INI, Bilirubin, Baseline, n=102, 99	9.4 (3.94)	9.7 (5.07)
INI, Bilirubin, Week 4, n=99, 97	9.5 (3.88)	9.0 (4.77)
INI, Bilirubin, Week 8, n=73, 98	10.1 (4.29)	10.7 (12.28)
INI, Bilirubin, Week 12, n=99, 95	9.9 (4.50)	9.2 (3.91)
INI, Bilirubin, Week 16, n=93, 96	9.8 (4.29)	9.6 (3.80)
INI, Bilirubin, Week 20, n=93, 97	10.1 (4.05)	9.3 (3.60)
INI, Bilirubin, Week 24, n=94, 94	9.4 (4.11)	9.1 (3.81)
INI, Bilirubin, Week 28, n=89, 93	10.3 (3.53)	9.5 (4.67)
INI, Bilirubin, Week 32, n=93, 95	9.9 (4.42)	8.8 (3.32)
INI, Bilirubin, Week 36, n=94, 95	9.8 (4.09)	9.1 (3.76)
INI, Bilirubin, Week 40, n=90, 95	9.9 (4.12)	8.9 (3.63)
INI, Bilirubin, Week 44, n=91, 94	10.1 (4.75)	9.0 (3.40)
INI, Bilirubin, Week 48, n=91, 95	10.3 (4.37)	8.9 (3.76)
NNRTI, Bilirubin, Baseline, n=155, 155	7.4 (3.30)	7.2 (3.30)
NNRTI, Bilirubin, Week 4, n=151, 153	8.7 (4.10)	6.9 (2.98)
NNRTI, Bilirubin, Week 8, n=122, 152	8.9 (4.01)	6.8 (3.40)
NNRTI, Bilirubin, Week 12, n=146, 152	9.3 (4.66)	7.1 (3.50)
NNRTI, Bilirubin, Week 16, n=143, 149	10.5 (14.51)	6.8 (3.52)
NNRTI, Bilirubin, Week 20, n=138, 152	9.6 (4.63)	7.1 (3.15)
NNRTI, Bilirubin, Week 24, n=143, 151	9.1 (3.93)	6.9 (3.75)
NNRTI, Bilirubin, Week 28, n=136, 150	9.7 (4.17)	6.9 (3.29)
NNRTI, Bilirubin, Week 32, n=137, 148	9.7 (4.55)	6.9 (3.52)
NNRTI, Bilirubin, Week 36, n=135, 147	9.3 (3.72)	7.0 (3.33)
NNRTI, Bilirubin, Week 40, n=138, 147	9.6 (4.21)	7.0 (3.43)
NNRTI, Bilirubin, Week 44, n=137, 148	9.4 (4.03)	7.1 (3.25)
NNRTI, Bilirubin, Week 48, n=131, 147	9.4 (4.28)	7.3 (3.19)
PI, Direct bilirubin, Baseline, n=51, 54	3.6 (2.13)	2.9 (1.68)
PI, Direct bilirubin, Week 4, n=51, 53	2.4 (1.20)	3.3 (1.67)
PI, Direct bilirubin, Week 8, n=34, 53	2.3 (1.12)	2.8 (1.68)
PI, Direct bilirubin, Week 12, n=50, 52	1.9 (0.80)	3.2 (1.95)
PI, direct bilirubin, Week 16, n=48, 53	2.0 (0.87)	2.9 (1.45)
PI, Direct bilirubin, Week 20, n=46, 53	2.2 (0.79)	2.9 (2.17)
PI, Direct bilirubin, Week 24, n=47, 53	2.2 (0.75)	3.1 (2.02)
PI, Direct bilirubin, Week 28, n=42, 53	2.1 (1.08)	2.7 (1.84)
PI, Direct bilirubin, Week 32, n=45, 51	2.2 (0.88)	3.1 (1.84)
PI, Direct bilirubin, Week 36, n=44, 50	1.9 (0.80)	3.1 (1.95)
PI, Direct bilirubin, Week 40, n=42, 51	2.0 (0.77)	3.2 (2.05)
PI, Direct bilirubin, Week 44, n=47, 51	2.1 (0.83)	3.3 (1.99)
PI, Direct bilirubin, Week 48, n=43, 50	2.3 (0.93)	3.2 (1.71)
INI, Direct bilirubin, Baseline, n=102, 99	2.4 (0.96)	2.3 (1.16)
INI, Direct bilirubin, Week 4, n=99, 97	2.4 (0.90)	2.3 (1.18)
INI, Direct bilirubin, Week 8, n=73, 98	2.4 (1.02)	3.0 (6.70)
INI, Direct bilirubin, Week 12, n=99, 95	2.3 (0.98)	2.3 (1.06)
INI, Direct bilirubin, Week 16, n=93, 96	2.3 (1.03)	2.1 (0.87)
INI, Direct bilirubin, Week 20, n=93, 97	2.2 (0.85)	2.1 (0.89)
INI, Direct bilirubin, Week 24, n=94, 94	2.2 (1.02)	2.0 (0.78)
INI, Direct bilirubin, Week 28, n=89, 93	2.2 (0.74)	2.1 (1.12)
INI, Direct bilirubin, Week 32, n=93, 95	2.2 (0.94)	1.9 (0.77)
INI, Direct bilirubin, Week 36, n=94, 95	2.2 (1.25)	2.0 (0.97)
INI, Direct bilirubin, Week 40, n=90, 95	2.2 (1.06)	2.0 (1.11)
INI, Direct bilirubin. Week 44, n=91, 94	2.3 (0.99)	2.1 (0.95)
INI, Direct bilirubin, Week 48, n=91, 95	2.3 (0.82)	2.2 (1.00)
NNRTI, Direct bilirubin, Baseline, n=155, 155	2.1 (1.00)	1.9 (1.00)
NNRTI, Direct bilirubin, Week 4, n=151, 153	2.2 (1.06)	2.0 (0.96)
NNRTI, Direct bilirubin, Week 8, n=122, 152	2.2 (1.10)	1.9 (0.97)
NNRTI, Direct bilirubin, Week 12, n=146, 152	2.2 (1.12)	1.9 (0.98)
NNRTI, Direct bilirubin, Week 16, n=143, 149	2.7 (6.95)	1.9 (0.90)
NNRTI, Direct bilirubin, Week 20, n=138, 152	2.2 (1.07)	1.7 (0.97)
NNRTI, Week 24, Direct bilirubin, n=143, 151	2.1 (1.04)	1.8 (0.95)
NNRTI, Direct bilirubin, Week 28, n=136, 150	2.1 (1.01)	1.7 (1.01)
NNRTI, Direct bilirubin, Week 32, n=137, 148	2.1 (1.08)	1.7 (0.94)
NNRTI, Direct bilirubin, Week 36, n=135, 147	2.1 (1.10)	1.7 (0.94)
NNRTI, Direct bilirubin, Week 40, n=138, 147	2.1 (1.18)	1.7 (1.00)
NNRTI, Direct bilirubin, Week 44, n=137, 148	2.1 (0.96)	1.8 (0.91)
NNRTI, Direct bilirubin, Week 48, n=131, 147	2.2 (0.98)	1.9 (0.96)
PI, Creatinine, Baseline, n=51, 54	71.41 (12.315)	70.20 (13.391)
PI, Creatinine, Week 4, n=51, 53	72.87 (11.632)	72.53 (14.574)
PI, Creatinine, Week 8, n=34, 53	71.66 (13.012)	71.54 (14.362)
PI, Creatinine, Week 12, n=50, 52	70.05 (11.609)	73.22 (14.968)
PI, Creatinine, Week 16, n=48, 53	71.05 (11.778)	73.25 (15.740)
PI, Creatinine, Week 20, n=46, 53	73.40 (12.191)	75.37 (15.799)
PI, Creatinine, Week 24, n=47, 53	72.75 (11.654)	72.84 (14.549)
PI, Creatinine, Week 28, n=42, 53	75.18 (13.118)	73.42 (14.738)
PI, Creatinine, Week 32, n=45, 51	74.59 (13.730)	73.93 (15.399)
PI, Creatinine, Week 36, n=44, 50	74.41 (12.217)	72.37 (14.570)
PI, Creatinine, Week 40, n=42, 51	74.31 (11.749)	73.73 (15.726)
PI, Creatinine, Week 44, n=47, 51	75.38 (13.405)	73.00 (14.885)
PI, Creatinine, Week 48, n=43, 50	76.95 (13.021)	72.21 (15.031)
INI, Creatinine, Baseline, n=102, 99	88.16 (16.835)	86.34 (17.320)
INI, Creatinine, Week 4, n=99, 95	86.39 (14.472)	87.66 (16.208)
INI, Creatinine, Week 8, n=73, 98	85.52 (15.851)	88.11 (17.308)
INI, Creatinine, Week 12, n=99, 95	85.53 (17.539)	89.36 (17.923)
INI, Creatinine, Week 16, n=93, 96	84.99 (15.429)	86.85 (17.320)
INI, Creatinine, Week 20, n=93, 97	85.01 (14.695)	87.06 (16.987)
INI, Creatinine, Week 24, n=94, 94	84.21 (15.039)	87.02 (16.777)
INI, Creatinine, Week 28, n=89, 93	84.84 (15.670)	87.41 (17.065)
INI, Creatinine, Week 32, n=93, 95	85.42 (15.349)	86.91 (15.628)
INI, Creatinine, Week 36, n=94, 95	84.49 (15.189)	87.20 (15.835)
INI, Creatinine, Week 40, n=90, 95	85.92 (14.651)	87.70 (17.119)
INI, Creatinine, Week 44, n=91, 94	84.66 (15.701)	87.08 (16.694)
INI, Creatinine, Week 48, n=91, 95	85.27 (15.683)	86.64 (15.958)
NNRTI, Creatinine, Baseline, n=155, 155	75.57 (14.604)	75.06 (14.671)
NNRTI, Creatinine, Week 4, n=151, 153	78.57 (15.814)	76.79 (14.908)
NNRTI, Creatinine, Week 8, n=122, 152	76.75 (15.759)	76.17 (14.876)
NNRTI, Creatinine, Week 12, n=146, 152	76.93 (15.495)	75.50 (14.723)
NNRTI, Creatinine, Week 16, n=143, 149	77.22 (15.406)	77.00 (16.025)
NNRTI, Creatinine, Week 20, n=138, 152	78.32 (16.372)	76.36 (15.744)
NNRTI, Creatinine, Week 24, n=143, 151	79.92 (21.430)	76.26 (15.534)
NNRTI, Creatinine, Week 28, n=136, 150	79.13 (17.039)	76.45 (15.060)
NNRTI, Creatinine, Week 32, n=137, 148	77.40 (14.117)	77.05 (16.200)
NNRTI, Creatinine, Week 36, n=135, 147	78.15 (16.839)	76.64 (15.734)
NNRTI, Creatinine, Week 40, n=138, 147	78.42 (16.662)	76.04 (15.083)
NNRTI, Creatinine, Week 44, n=137, 148	78.45 (15.909)	76.25 (15.257)
NNRTI, Creatinine, Week 48, n=131, 147	78.91 (17.389)	75.67 (14.794)

51. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance
Description	Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Baseline, n=51, 54	105.2 (15.67)	104.9 (15.22)
PI, Week 4, n=51, 53	103.0 (15.59)	102.1 (15.68)
PI, Week 8, n=34, 53	104.3 (14.52)	103.5 (15.61)
PI, Week 12, n=50, 52	107.1 (14.95)	101.1 (15.94)
PI, Week 16, n=48, 53	105.4 (15.88)	101.8 (15.99)
PI, Week 20, n=46, 53	102.9 (17.17)	99.8 (16.53)
PI, Week 24, n=47, 53	103.3 (14.64)	101.0 (15.54)
PI, Week 28, n=42, 53	100.6 (16.62)	100.8 (14.58)
PI, Week 32, n=45, 51	101.0 (17.38)	100.4 (16.04)
PI, Week 36, n=44, 50	100.7 (16.68)	101.7 (14.42)
PI, Week 40, n=42, 51	100.2 (14.54)	100.3 (15.51)
PI, Week 44, n=47, 51	99.8 (18.00)	101.0 (15.31)
PI, Week 48, n=43, 50	98.8 (17.31)	102.2 (15.45)
INI, Baseline, n=102, 99	92.3 (17.62)	94.9 (18.82)
INI, Week 4, n=99, 95	93.4 (15.07)	93.1 (18.22)
INI, Week 8, n=72, 98	94.4 (17.05)	93.0 (18.12)
INI, Week 12, n=99, 93	94.5 (16.82)	91.6 (18.81)
INI, Week 16, n=93, 96	94.9 (16.02)	94.4 (18.30)
INI, Week 20, n=93, 97	95.3 (15.97)	93.3 (17.48)
INI, Week 24, n=94, 94	95.6 (15.88)	93.1 (17.21)
INI, Week 28, n=89, 93	95.4 (17.00)	93.6 (17.89)
INI, Week 32, n=92, 95	94.8 (17.16)	93.1 (16.94)
INI, Week 36, n=94, 95	95.6 (15.81)	92.7 (15.65)
INI, Week 40, n=89, 95	94.8 (16.32)	92.9 (18.15)
INI, Week 44, n=91, 94	94.8 (15.64)	93.4 (17.94)
INI, Week 48, n=90, 94	95.4 (16.20)	93.5 (17.00)
NNRTI, Baseline, n=155, 155	104.4 (17.78)	103.7 (16.85)
NNRTI, Week 4, n=151, 153	100.8 (18.35)	101.5 (17.72)
NNRTI, Week 8, n=121, 152	102.3 (17.23)	102.2 (16.85)
NNRTI, Week 12, n=146, 152	103.1 (18.02)	103.2 (17.47)
NNRTI, Week 16, n=143, 148	102.5 (17.66)	101.0 (18.66)
NNRTI, Week 20, n=138, 152	101.0 (17.94)	101.8 (17.61)
NNRTI, Week 24, n=142, 151	99.6 (18.18)	101.7 (17.43)
NNRTI, Week 28, n=136, 150	99.9 (18.23)	101.7 (17.20)
NNRTI, Week 32, n=137, 148	101.3 (16.10)	101.0 (17.79)
NNRTI, Week 36, n=135, 147	100.8 (18.02)	101.4 (17.46)
NNRTI, Week 40, n=137, 147	100.5 (18.40)	101.6 (16.68)
NNRTI, Week 44, n=136, 148	99.9 (17.23)	101.8 (16.96)
NNRTI, Week 48, n=131, 147	98.7 (17.35)	102.1 (16.83)

52. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase
Description	Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Baseline, n=51, 54	27.6 (21.69)	33.0 (22.44)
PI, Week 4, n=51, 53	25.5 (14.41)	34.4 (20.77)
PI, Week 8, n=34, 53	23.4 (10.96)	35.7 (28.85)
PI, Week 12, n=49, 52	26.4 (12.00)	31.2 (15.31)
PI, Week 16, n=47, 53	28.1 (13.01)	34.6 (18.14)
PI, Week 20, n=46, 53	25.8 (11.37)	32.7 (16.37)
PI, Week 24, n=47, 53	25.8 (11.74)	30.5 (15.48)
PI, Week 28, n=42, 53	26.4 (10.86)	33.4 (15.92)
PI, Week 32, n=45, 51	26.9 (12.18)	36.2 (24.23)
PI, Week 36, n=44, 50	27.1 (13.69)	32.7 (17.14)
PI, Week 40, n=42, 51	30.5 (19.78)	32.0 (15.16)
PI, Week 44, n=47, 51	27.1 (10.70)	35.2 (18.59)
PI, Week 48, n=43, 50	26.3 (12.02)	32.7 (15.62)
INI, Baseline, n=102, 99	29.3 (20.90)	28.2 (16.64)
INI, Week 4, n=99, 97	36.8 (43.46)	32.1 (31.31)
INI, Week 8, n=72, 98	28.8 (16.80)	27.7 (12.72)
INI, Week 12, n=99, 93	33.1 (20.98)	29.8 (23.81)
INI, Week 16, n=93, 97	34.4 (33.09)	28.9 (14.77)
INI, Week 20, n=94, 97	32.0 (28.19)	29.1 (16.34)
INI, Week 24, n=94, 95	32.0 (19.15)	30.1 (21.56)
INI, Week 28, n=89, 94	35.1 (38.32)	32.8 (24.85)
INI, Week 32, n=92, 95	32.6 (23.00)	32.7 (21.75)
INI, Week 36, n=94, 95	35.0 (32.32)	27.6 (12.20)
INI, Week 40, n=89, 95	33.8 (20.14)	29.6 (14.21)
INI, Week 44, n=91, 94	34.6 (34.66)	32.8 (22.45)
INI, Week 48, n=90, 94	35.1 (36.88)	31.6 (23.18)
NNRTI, Baseline, n=155, 155	32.1 (24.46)	31.8 (19.30)
NNRTI, Week 4, n=151, 153	37.6 (64.95)	31.7 (17.60)
NNRTI, Week 8, n=121, 152	33.8 (27.26)	33.4 (21.17)
NNRTI, Week 12, n=146, 152	35.6 (34.76)	29.7 (14.64)
NNRTI, Week 16, n=145, 149	35.3 (32.66)	36.8 (46.27)
NNRTI, Week 20, n=138, 152	32.0 (19.03)	32.9 (37.34)
NNRTI, Week 24, n=142, 151	36.2 (29.08)	37.2 (36.77)
NNRTI, Week 28, n=136, 150	33.4 (21.71)	33.1 (17.20)
NNRTI, Week 32, n=137, 148	40.6 (83.20)	33.6 (20.70)
NNRTI, Week 36, n=135, 147	39.9 (67.63)	33.9 (21.66)
NNRTI, Week 40, n=138, 147	38.6 (46.34)	32.3 (16.96)
NNRTI, Week 44, n=136, 148	34.5 (23.27)	32.9 (19.81)
NNRTI, Week 48, n=131, 146	36.3 (30.60)	32.8 (20.04)

53. Secondary Outcome

Title	Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48
Description	Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, CO2, Baseline, n=51, 54	22.3 (2.53)	22.7 (2.17)
PI, CO2, Week 4, n=51, 53	23.6 (2.37)	23.4 (2.28)
PI, CO2, Week 8, n=34, 53	23.0 (1.95)	23.0 (2.53)
PI, CO2, Week 12, n=50, 52	22.9 (2.14)	22.9 (2.41)
PI, CO2, Week 16, n=48, 53	23.0 (2.07)	22.9 (2.32)
PI, CO2, Week 20, n=46, 53	23.1 (2.04)	22.7 (2.59)
PI, CO2, Week 24, n=47, 53	22.7 (1.95)	22.8 (2.62)
PI, CO2, Week 28, n=42, 53	22.7 (2.31)	22.5 (2.48)
PI, CO2, Week 32, n=45, 51	22.6 (2.22)	22.6 (2.84)
PI, CO2, Week 36, n=44, 50	22.6 (2.21)	22.4 (2.36)
PI, CO2, Week 40, n=42, 51	22.8 (2.24)	23.1 (2.37)
PI, CO2, Week 44, n=47, 51	22.9 (1.94)	23.1 (2.37)
PI, CO2, Week 48, n=43, 50	23.0 (2.01)	22.7 (2.19)
INI, CO2, Baseline, n=102, 99	22.8 (2.09)	22.9 (2.08)
INI, CO2, Week 4, n=99, 97	23.7 (2.36)	23.7 (2.28)
INI, CO2, Week 8, n=73, 98	23.0 (2.10)	23.6 (2.20)
INI, CO2, Week 12, n=99, 95	23.2 (2.07)	23.3 (2.26)
INI, CO2, Week 16, n=93, 96	22.8 (2.10)	23.5 (2.39)
INI, CO2, Week 20, n=93, 97	22.8 (2.11)	23.6 (2.14)
INI, CO2, Week 24, n=94, 95	22.8 (2.22)	23.1 (2.21)
INI, CO2, Week 28, n=89, 93	22.5 (2.21)	23.1 (2.14)
INI, CO2, Week 32, n=93, 95	22.8 (2.17)	23.0 (2.09)
INI, CO2, Week 36, n=94, 95	22.8 (1.90)	23.5 (2.12)
INI, CO2, Week 40, n=90, 95	23.1 (2.07)	23.2 (2.09)
INI, CO2, Week 44, n=91, 94	23.1 (2.08)	23.7 (2.11)
INI, CO2, Week 48, n=91, 95	22.9 (1.97)	23.3 (2.32)
NNRTI, CO2, Baseline, n=155, 155	22.7 (2.41)	22.3 (2.35)
NNRTI, CO2, Week 4, n=151, 153	23.7 (2.63)	23.0 (2.24)
NNRTI, CO2, Week 8, n=122, 152	23.2 (2.28)	23.1 (2.61)
NNRTI, CO2, Week 12, n=146, 152	23.2 (2.18)	22.8 (2.39)
NNRTI, CO2, Week 16, n=143, 149	23.0 (2.24)	22.8 (2.23)
NNRTI, CO2, Week 20, n=138, 152	22.9 (2.24)	22.5 (2.20)
NNRTI, CO2, Week 24, n=143, 150	23.0 (2.49)	22.7 (2.45)
NNRTI, CO2, Week 28, n=136, 150	22.8 (2.58)	22.6 (2.27)
NNRTI, CO2, Week 32, n=137, 148	22.5 (2.11)	22.7 (2.29)
NNRTI, CO2, Week 36, n=135, 147	22.8 (2.38)	22.8 (2.27)
NNRTI, CO2, Week 40, n=138, 147	23.1 (2.40)	22.8 (2.68)
NNRTI, CO2, Week 44, n=137, 148	23.0 (2.35)	22.8 (2.38)
NNRTI, CO2, Week 48, n=131, 147	22.5 (2.55)	22.6 (2.29)
PI, Chloride, Baseline, n=51, 54	104.0 (1.46)	103.5 (2.61)
PI, Chloride, Week 4, n=51, 53	104.5 (1.80)	104.0 (2.10)
PI, Chloride, Week 8, n=34, 53	104.4 (2.35)	104.2 (2.28)
PI, Chloride, Week 12, n=50, 52	104.4 (2.02)	104.3 (2.13)
PI, Chloride, Week 16, n=48, 53	104.4 (2.08)	104.5 (2.10)
PI, Chloride, Week 20, n=46, 53	104.8 (1.98)	104.2 (1.97)
PI, Chloride, Week 24, n=47, 53	105.1 (1.85)	104.7 (2.02)
PI, Chloride, Week 28, n=42, 53	105.3 (1.88)	104.6 (2.47)
PI, Chloride, Week 32, n=45, 51	105.0 (2.32)	104.4 (1.92)
PI, Chloride, Week 36, n=44, 50	105.0 (2.17)	104.4 (2.27)
PI, Chloride, Week 40, n=42, 51	105.2 (2.27)	104.5 (2.31)
PI, Chloride, Week 44, n=47, 51	105.1 (1.84)	104.5 (1.88)
PI, Chloride, Week 48, n=43, 50	104.4 (1.72)	104.3 (1.88)
INI, Chloride, Baseline, n=102, 99	103.6 (2.03)	103.5 (2.26)
INI, Chloride, Week 4, n=99, 97	104.0 (2.17)	104.0 (2.15)
INI, Chloride, Week 8, n=73, 98	104.1 (2.16)	103.5 (2.58)
INI, Chloride, Week 12, n=99, 95	104.1 (2.31)	104.0 (2.32)
INI, Chloride, Week 16, n=93, 96	104.7 (2.05)	104.2 (2.26)
INI, Chloride, Week 20, n=93, 97	104.8 (2.39)	103.8 (2.36)
INI, Chloride, Week 24, n=94, 95	104.3 (2.30)	104.1 (2.50)
INI, Chloride, Week 28, n=89, 93	104.7 (1.92)	104.0 (2.16)
INI, Chloride, Week 32, n=93, 95	104.5 (2.33)	104.2 (2.47)
INI, Chloride, Week 36, n=94, 95	104.6 (2.04)	104.1 (2.40)
INI, Chloride, Week 40, n=90, 95	104.4 (1.94)	103.9 (2.48)
INI, Chloride, Week 44, n=91, 94	104.5 (2.12)	104.0 (2.27)
INI, Chloride, Week 48, n=91, 95	104.2 (2.43)	103.2 (2.26)
NNRTI, Chloride, Baseline, n=155, 155	103.9 (2.18)	104.0 (2.37)
NNRTI, Chloride, Week 4, n=151, 153	104.3 (2.21)	104.6 (2.29)
NNRTI, Chloride, Week 8, n=122, 152	104.4 (2.31)	104.7 (2.22)
NNRTI, Chloride, Week 12, n=146, 152	104.3 (2.33)	104.5 (2.23)
NNRTI, Chloride, Week 16, n=143, 149	104.4 (2.37)	104.8 (2.34)
NNRTI, Chloride, Week 20, n=138, 152	104.6 (2.55)	105.1 (2.38)
NNRTI, Chloride, Week 24, n=143, 151	104.4 (2.52)	105.1 (2.18)
NNRTI, Chloride, Week 28, n=136, 150	104.7 (2.41)	105.3 (2.31)
NNRTI, Chloride, Week 32, n=137, 148	104.7 (2.68)	105.1 (2.26)
NNRTI, Chloride, Week 36, n=135, 147	105.0 (2.28)	105.1 (2.30)
NNRTI, Chloride, Week 40, n=138, 147	104.7 (2.36)	105.0 (2.70)
NNRTI, Chloride, Week 44, n=137, 148	104.6 (2.17)	105.0 (2.32)
NNRTI, Chloride, Week 48, n=131, 147	104.6 (2.54)	104.5 (2.46)
PI, Glucose, Baseline, n=51, 53	5.11 (0.878)	5.03 (0.505)
PI, Glucose, Week 4, n=43, 43	5.06 (0.481)	5.29 (0.452)
PI, Glucose, Week 8, n=25, 41	5.11 (0.456)	5.18 (0.462)
PI, Glucose, Week 12, n=40, 43	5.21 (0.533)	5.25 (0.535)
PI, Glucose, Week 16, n=39, 44	5.24 (0.800)	5.26 (0.614)
PI, Glucose, Week 20, n=35, 42	5.11 (0.580)	5.29 (0.718)
PI, Glucose, Week 24, n=38, 43	5.31 (0.526)	5.29 (0.747)
PI, Glucose, Week 28, n=32, 43	5.16 (0.651)	5.12 (0.512)
PI, Glucose, Week 32, n=36, 42	5.37 (0.700)	5.31 (0.643)
PI, Glucose, Week 36, n=35, 42	5.13 (0.525)	5.23 (0.513)
PI, Glucose, Week 40, n=34, 41	5.31 (0.464)	5.17 (0.555)
PI, Glucose, Week 44, n=40, 40	5.13 (0.681)	5.20 (0.408)
PI, Glucose, Week 48, n=39, 48	5.16 (0.647)	5.18 (0.661)
INI, Glucose, Baseline, n=98, 96	5.06 (0.638)	5.25 (0.801)
INI, Glucose, Week 4, n=55, 54	5.39 (0.771)	5.37 (1.043)
INI, Glucose, Week 8, n=36, 58	5.16 (0.584)	5.49 (1.307)
INI, Glucose, Week 12, n=53, 56	5.50 (1.317)	5.51 (1.414)
INI, Glucose, Week 16, n=54, 53	5.41 (1.727)	5.25 (0.624)
INI, Glucose, Week 20, n=52, 58	5.36 (0.674)	5.21 (0.793)
INI, Glucose, Week 24, n=61, 62	5.34 (0.660)	5.36 (0.753)
INI, Glucose, Week 28, n=53, 63	5.32 (0.817)	5.45 (0.940)
INI, Glucose, Week 32, n=54, 56	5.57 (1.260)	5.52 (0.839)
INI, Glucose, Week 36, n=53, 58	5.46 (0.697)	5.34 (1.142)
INI, Glucose, Week 40, n=59, 63	5.53 (0.931)	5.46 (0.765)
INI, Glucose, Week 44, n=54, 57	5.40 (1.020)	5.43 (0.637)
INI, Glucose, Week 48, n=84, 91	5.16 (0.549)	5.24 (0.752)
NNRTI, Glucose, Baseline, n=152, 150	4.93 (0.697)	5.17 (1.201)
NNRTI, Glucose, Week 4, n=118, 129	5.11 (0.798)	5.48 (1.490)
NNRTI, Glucose, Week 8, n=92, 119	5.17 (1.204)	5.35 (1.030)
NNRTI, Glucose, Week 12, n=113, 122	5.04 (0.856)	5.30 (1.067)
NNRTI, Glucose, Week 16, n=116, 119	5.12 (0.914)	5.45 (1.683)
NNRTI, Glucose, Week 20, n=107, 121	5.16 (0.802)	5.48 (1.476)
NNRTI, Glucose, Week 24, n=116, 124	5.16 (0.944)	5.36 (0.914)
NNRTI, Glucose, Week 28, n=105, 120	5.08 (0.635)	5.40 (0.934)
NNRTI, Glucose, Week 32, n=104, 121	5.18 (1.000)	5.47 (1.316)
NNRTI, Glucose, Week 36, n=103, 120	5.07 (0.856)	5.49 (1.857)
NNRTI, Glucose, Week 40, n=102, 114	5.16 (0.776)	5.53 (1.558)
NNRTI, Glucose, Week 44, n=99, 116	5.15 (0.877)	5.53 (1.708)
NNRTI, Glucose, Week 48, n=119, 138	5.01 (0.640)	5.23 (1.160)
PI, Phosphate, Baseline, n=51, 54	1.048 (0.1523)	1.060 (0.1719)
PI, Phosphate, Week 4, n=51, 53	1.116 (0.1648)	1.069 (0.1647)
PI, Phosphate, Week 8, n=34, 53	1.119 (0.1891)	1.041 (0.1664)
PI, Phosphate, Week 12, n=50, 52	1.073 (0.1788)	1.064 (0.1872)
PI, Phosphate, Week 16, n=48, 53	1.111 (0.2006)	1.051 (0.1849)
PI, Phosphate, Week 20, n=46, 53	1.119 (0.1689)	1.076 (0.2187)
PI, Phosphate, Week 24, n=47, 53	1.086 (0.1647)	1.077 (0.1631)
PI, Phosphate, Week 28, n=42, 53	1.085 (0.1803)	1.076 (0.1970)
PI, Phosphate, Week 32, n=45, 51	1.109 (0.1869)	1.081 (0.1769)
PI, Phosphate, Week 36, n=44, 50	1.084 (0.1659)	1.058 (0.1830)
PI, Phosphate, Week 40, n=42, 51	1.067 (0.2020)	1.053 (0.1932)
PI, Phosphate, Week 44, n=47, 51	1.084 (0.1785)	1.063 (0.2227)
PI, Phosphate, Week 48, n=43, 50	1.095 (0.1636)	1.070 (0.1804)
INI, Phosphate, Baseline, n=102, 99	1.045 (0.1687)	1.063 (0.1700)
INI, Phosphate, Week 4, n=99, 97	1.080 (0.1725)	1.082 (0.1857)
INI, Phosphate, Week 8, n=73, 98	1.086 (0.1901)	1.071 (0.2001)
INI, Phosphate, Week 12, n=99, 95	1.068 (0.1970)	1.078 (0.1823)
INI, Phosphate, Week 16, n=93, 96	1.063 (0.1623)	1.061 (0.1702)
INI, Phosphate, Week 20, n=93, 97	1.046 (0.1717)	1.091 (0.1757)
INI, Phosphate, Week 24, n=94, 95	1.066 (0.1661)	1.052 (0.1921)
INI, Phosphate, Week 28, n=89, 93	1.060 (0.1602)	1.065 (0.1835)
INI, Phosphate, Week 32, n=93, 95	1.045 (0.1649)	1.045 (0.1569)
INI, Phosphate, Week 36, n=94, 95	1.032 (0.1572)	1.059 (0.1800)
INI, Phosphate, Week 40, n=90, 95	1.054 (0.1838)	1.062 (0.1731)
INI, Phosphate, Week 44, n=91, 94	1.043 (0.1805)	1.066 (0.2029)
INI, Phosphate, Week 48, n=91, 95	1.072 (0.1721)	1.066 (0.1918)
NNRTI, Phosphate, Baseline, n=155, 155	1.038 (0.1905)	1.040 (0.1741)
NNRTI, Phosphate, Week 4, n=151, 153	1.128 (0.1867)	1.056 (0.1764)
NNRTI, Phosphate, Week 8, n=122, 152	1.097 (0.1994)	1.024 (0.1784)
NNRTI, Phosphate, Week 12, n=146, 152	1.091 (0.1838)	1.051 (0.2002)
NNRTI, Phosphate, Week 16, n=143, 149	1.082 (0.1827)	1.046 (0.1700)
NNRTI, Phosphate, Week 20, n=138, 152	1.076 (0.1763)	1.037 (0.1806)
NNRTI, Phosphate, Week 24, n=143, 151	1.091 (0.1914)	1.052 (0.1882)
NNRTI, Phosphate, Week 28, n=136, 150	1.076 (0.1764)	1.038 (0.1585)
NNRTI, Phosphate, Week 32, n=137, 148	1.057 (0.1722)	1.050 (0.1874)
NNRTI, Phosphate, Week 36, n=135, 147	1.055 (0.1790)	1.039 (0.1793)
NNRTI, Phosphate, Week 40, n=138, 147	1.071 (0.1689)	1.033 (0.1724)
NNRTI, Phosphate, Week 44, n=137, 148	1.076 (0.1795)	1.040 (0.1693)
NNRTI, Phosphate, Week 48, n=131, 147	1.075 (0.1941)	1.037 (0.1789)
PI, Potassium, Baseline, n=51, 54	4.13 (0.288)	4.10 (0.308)
PI, Potassium, Week 4, n=51, 53	4.25 (0.355)	4.31 (0.395)
PI, Potassium, Week 8, n=34, 53	4.18 (0.283)	4.19 (0.331)
PI, Potassium, Week 12, n=50, 52	4.25 (0.335)	4.31 (0.364)
PI, Potassium, Week 16, n=48, 53	4.16 (0.322)	4.30 (0.359)
PI, Potassium, Week 20, n=46, 53	4.18 (0.291)	4.29 (0.314)
PI, Potassium, Week 24, n=47, 53	4.15 (0.335)	4.30 (0.379)
PI, Potassium, Week 28, n=42, 53	4.21 (0.342)	4.26 (0.348)
PI, Potassium, Week 32, n=45, 51	4.15 (0.326)	4.31 (0.367)
PI, Potassium, Week 36, n=44, 50	4.25 (0.345)	4.26 (0.378)
PI, Potassium, Week 40, n=42, 51	4.23 (0.293)	4.26 (0.363)
PI, Potassium, Week 44, n=47, 51	4.24 (0.348)	4.32 (0.375)
PI, Potassium, Week 48, n=43, 50	4.15 (0.292)	4.12 (0.320)
INI, Potassium, Baseline, n=102, 99	4.17 (0.245)	4.18 (0.289)
INI, Potassium, Week 4, n=99, 97	4.20 (0.311)	4.26 (0.359)
INI, Potassium, Week 8, n=73, 98	4.14 (0.306)	4.24 (0.462)
INI, Potassium, Week 12, n=99, 95	4.19 (0.340)	4.18 (0.291)
INI, Potassium, Week 16, n=93, 96	4.15 (0.317)	4.19 (0.297)
INI, Potassium, Week 20, n=93, 97	4.20 (0.299)	4.18 (0.289)
INI, Potassium, Week 24, n=94, 95	4.19 (0.304)	4.21 (0.304)
INI, Potassium,Week 28, n=89, 93	4.19 (0.412)	4.22 (0.341)
INI, Potassium, Week 32, n=93, 95	4.20 (0.358)	4.19 (0.307)
INI, Potassium, Week 36, n=94, 95	4.19 (0.365)	4.23 (0.332)
INI, Potassium, Week 40, n=90, 95	4.18 (0.332)	4.19 (0.297)
INI, Potassium, Week 44, n=91, 94	4.18 (0.309)	4.17 (0.314)
INI, Potassium, Week 48, n=91, 95	4.15 (0.266)	4.16 (0.305)
NNRTI, Potassium, Baseline, n=155, 155	4.16 (0.302)	4.18 (0.331)
NNRTI, Potassium, Week 4, n=151, 153	4.21 (0.287)	4.28 (0.333)
NNRTI, Potassium, Week 8, n=122, 152	4.17 (0.295)	4.23 (0.366)
NNRTI, Potassium, Week 12, n=146, 152	4.18 (0.322)	4.26 (0.341)
NNRTI, Potassium, Week 16, n=143, 149	4.20 (0.313)	4.23 (0.320)
NNRTI, Potassium,Week 20, n=138, 152	4.20 (0.326)	4.21 (0.337)
NNRTI, Potassium, Week 24, n=143, 150	4.19 (0.259)	4.22 (0.341)
NNRTI, Potassium, Week 28, n=136, 150	4.18 (0.301)	4.25 (0.434)
NNRTI, Potassium, Week 32, n=137, 148	4.17 (0.388)	4.20 (0.349)
NNRTI, Potassium, Week 36, n=135, 147	4.17 (0.289)	4.22 (0.343)
NNRTI, Potassium, Week 40, n=138, 147	4.20 (0.283)	4.26 (0.321)
NNRTI, Potassium, Week 44, n=137, 148	4.23 (0.324)	4.24 (0.374)
NNRTI, Potassium, Week 48, n=131, 147	4.14 (0.271)	4.17 (0.352)
PI, Sodium, Baseline, n=51, 54	138.9 (2.15)	138.7 (2.10)
PI, Sodium, Week 4, n=51, 53	139.3 (1.64)	139.0 (2.08)
PI, Sodium, Week 8, n=34, 53	139.6 (2.10)	139.0 (1.95)
PI, Sodium, Week 12, n=50, 52	139.3 (1.76)	139.4 (2.03)
PI, Sodium, Week 16, n=48, 53	139.4 (2.18)	139.0 (1.75)
PI, Sodium, Week 20, n=46, 53	139.6 (1.71)	139.1 (1.97)
PI, Sodium, Week 24, n=47, 53	139.4 (2.08)	139.1 (2.07)
PI, Sodium, Week 28, n=42, 53	140.3 (1.59)	139.5 (2.49)
PI, Sodium, Week 32, n=45, 51	139.4 (2.14)	139.3 (2.28)
PI, Sodium, Week 36, n=44, 50	139.7 (1.63)	139.4 (2.32)
PI, Sodium, Week 40, n=42, 51	139.8 (1.94)	139.4 (1.93)
PI, Sodium, Week 44, n=47, 51	139.7 (1.78)	139.4 (2.09)
PI, Sodium, Week 48, n=43, 50	139.8 (1.86)	139.6 (1.90)
INI, Sodium, Baseline, n=102, 99	138.8 (1.62)	139.0 (1.67)
INI, Sodium, Week 4, n=99, 97	139.2 (1.58)	139.1 (1.72)
INI, Sodium, Week 8, n=73, 98	138.8 (2.00)	138.8 (1.79)
INI, Sodium, Week 12, n=99, 95	139.1 (1.97)	139.0 (1.88)
INI, Sodium, Week 16, n=93, 96	139.1 (1.87)	139.4 (1.89)
INI, Sodium, Week 20, n=93, 97	139.4 (1.92)	139.2 (1.67)
INI, Sodium, Week 24, n=94, 95	139.3 (1.86)	139.1 (1.91)
INI, Sodium, Week 28, n=89, 93	139.4 (1.65)	138.8 (1.67)
INI, Sodium, Week 32, n=93, 95	139.4 (1.63)	139.2 (1.68)
INI, Sodium, Week 36, n=94, 95	139.2 (1.84)	139.4 (1.99)
INI, Sodium, Week 40, n=90, 95	139.3 (2.01)	139.3 (1.83)
INI, Sodium, Week 44, n=91, 94	139.3 (1.67)	139.4 (1.88)
INI, Sodium, Week 48, n=91, 95	139.3 (1.98)	139.0 (1.76)
NNRTI, Sodium, Baseline, n=155, 155	139.1 (2.00)	139.2 (1.68)
NNRTI, Sodium, Week 4, n=151, 153	139.4 (1.79)	139.2 (1.90)
NNRTI, Sodium, Week 8, n=122, 152	139.1 (1.91)	139.2 (1.76)
NNRTI, Sodium, Week 12, n=146, 152	139.2 (1.78)	139.2 (1.77)
NNRTI, Sodium, Week 16, n=143, 149	139.0 (1.99)	139.0 (2.06)
NNRTI, Sodium, Week 20, n=138, 152	139.0 (1.87)	139.5 (1.83)
NNRTI, Sodium, Week 24, n=143, 151	139.2 (1.83)	139.4 (1.94)
NNRTI, Sodium, Week 28, n=136, 150	139.3 (1.84)	139.4 (1.99)
NNRTI, Sodium, Week 32, n=137, 148	139.2 (1.68)	139.7 (1.75)
NNRTI, Sodium, Week 36, n=135, 147	139.4 (1.80)	139.7 (2.19)
NNRTI, Sodium, Week 40, n=138, 147	139.4 (1.87)	139.7 (2.06)
NNRTI, Sodium, Week 44, n=137, 148	139.5 (1.88)	139.7 (1.92)
NNRTI, Sodium, Week 48, n=131, 147	139.4 (1.93)	139.5 (1.82)
PI, Urea, Baseline, n=51, 54	4.97 (1.409)	4.89 (1.316)
PI, Urea, Week 4, n=51, 53	4.99 (1.210)	4.91 (1.455)
PI, Urea, Week 8, n=34, 53	5.10 (1.353)	4.88 (1.447)
PI, Urea, Week 12, n=50, 52	5.03 (1.368)	4.85 (1.480)
PI, Urea, Week 16, n=48, 53	5.20 (1.295)	5.09 (1.754)
PI, Urea, Week 20, n=46, 53	5.18 (1.216)	5.07 (1.535)
PI, Urea, Week 24, n=47, 53	5.44 (1.587)	5.00 (1.414)
PI, Urea, Week 28, n=42, 53	5.21 (1.358)	4.90 (1.530)
PI, Urea, Week 32, n=45, 51	5.13 (1.135)	5.09 (1.482)
PI, Urea, Week 36, n=44, 50	4.99 (1.310)	4.78 (1.411)
PI, Urea, Week 40, n=42, 51	5.35 (1.227)	5.30 (1.758)
PI, Urea, Week 44, n=47, 51	5.38 (1.483)	5.10 (1.517)
PI, Urea, Week 48, n=43, 50	5.22 (1.469)	5.11 (1.489)
INI, Urea, Baseline, n=102, 99	5.76 (1.528)	5.61 (1.894)
INI, Urea, Week 4, n=99, 97	5.63 (1.471)	5.77 (1.676)
INI, Urea, Week 8, n=73, 98	5.80 (1.617)	5.60 (1.607)
INI, Urea, Week 12, n=99, 95	5.81 (1.536)	5.83 (1.724)
INI, Urea, Week 16, n=93, 96	5.76 (1.577)	5.70 (1.574)
INI, Urea, Week 20, n=93, 97	5.75 (1.640)	5.76 (1.580)
INI, Urea, Week 24, n=94, 95	5.84 (1.578)	5.72 (1.774)
INI, Urea, Week 28, n=89, 93	5.76 (1.593)	5.65 (1.435)
INI, Urea, Week 32, n=93, 95	5.67 (1.537)	5.63 (1.477)
INI, Urea, Week 36, n=94, 95	5.67 (1.670)	5.53 (1.456)
INI, Urea, Week 40, n=90, 95	5.81 (1.669)	5.66 (1.593)
INI, Urea, Week 44, n=91, 94	5.59 (1.607)	5.46 (1.368)
INI, Urea, Week 48, n=91, 95	5.83 (1.654)	5.50 (1.468)
NNRTI, Urea, Baseline, n=155, 155	4.96 (1.519)	5.10 (1.510)
NNRTI, Urea, Week 4, n=151, 153	5.08 (1.556)	5.09 (1.426)
NNRTI, Urea, Week 8, n=122, 152	5.09 (1.675)	5.10 (1.465)
NNRTI, Urea, Week 12, n=146, 152	5.20 (1.684)	5.13 (1.583)
NNRTI, Urea, Week 16, n=143, 149	5.03 (1.768)	5.34 (1.660)
NNRTI, Urea, Week 20, n=138, 152	5.18 (1.709)	5.15 (1.713)
NNRTI, Urea, Week 24, n=143, 151	5.29 (1.878)	5.26 (1.591)
NNRTI, Urea, Week 28, n=136, 150	5.20 (1.931)	5.10 (1.537)
NNRTI, Urea, Week 32, n=137, 148	5.38 (1.796)	5.14 (1.687)
NNRTI, Urea, Week 36, n=135, 147	5.07 (1.719)	5.13 (1.493)
NNRTI, Urea, Week 40, n=138, 147	5.30 (1.616)	5.07 (1.377)
NNRTI, Urea, Week 44, n=137, 148	5.23 (1.489)	5.18 (1.613)
NNRTI, Urea, Week 48, n=131, 147	5.32 (1.671)	5.06 (1.380)

54. Secondary Outcome

Title	Absolute Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48
Description	Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Time Frame	Baseline (Day 1) and at Week 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Triglycerides, Baseline, n=46, 50	1.951 (1.8801)	1.894 (1.4058)
PI, Triglycerides, Week 48, n=40, 45	1.309 (0.7647)	1.772 (1.1828)
INI, Triglycerides, Baseline, n=82, 84	1.470 (1.0152)	1.426 (0.8720)
INI, Triglycerides, Week 48, n=72, 77	1.405 (0.9068)	1.307 (0.7427)
NNRTI, Triglycerides, Baseline, n=136, 140	1.322 (0.7986)	1.506 (1.4388)
NNRTI, Triglycerides, Week 48, n=119, 120	1.305 (0.8771)	1.316 (0.7914)
PI, Cholesterol, Baseline, n=46, 50	4.98 (0.960)	5.14 (1.152)
PI, Cholesterol, Week 48, n=40, 45	5.07 (0.775)	5.16 (1.130)
INI, Cholesterol, Baseline, n=82, 84	4.81 (1.077)	5.01 (1.080)
INI, Cholesterol, Week 48, n=72, 77	4.90 (0.881)	4.87 (0.997)
NNRTI, Cholesterol, Baseline, n=136, 140	4.87 (0.958)	4.98 (1.007)
NNRTI, Cholesterol, Week 48, n=119, 120	4.93 (0.904)	4.91 (1.007)
PI, HDL cholesterol, Baseline, n=46, 50	1.389 (0.4943)	1.537 (0.6096)
PI, HDL cholesterol, Week 48, n=40, 45	1.505 (0.5459)	1.550 (0.5950)
INI, HDL cholesterol, Baseline, n=82, 84	1.257 (0.3450)	1.383 (0.3890)
INI, HDL cholesterol, Week 48, n=72, 77	1.288 (0.3664)	1.323 (0.3588)
NNRTI, HDL cholesterol, Baseline, n=136, 140	1.449 (0.4756)	1.405 (0.4401)
NNRTI, HDL cholesterol, Week 48, n=119, 120	1.442 (0.4413)	1.471 (0.4226)
PI, LDL cholesterol, Baseline, n=43, 48	2.734 (0.7891)	2.743 (0.7948)
PI, LDL cholesterol, Week 48, n=37, 43	2.944 (0.7175)	2.784 (0.8477)
INI, LDL cholesterol, Basline, n=81, 83	2.881 (0.9196)	2.946 (0.8614)
INI, LDL cholesterol, Week 48, n=71, 76	2.975 (0.8787)	2.939 (0.8591)
NNRTI, LDL cholesterol, Baseline, n=134, 137	2.834 (0.8442)	2.901 (0.8714)
NNRTI, LDL cholesterol, Week 48, n=116, 119	2.900 (0.8415)	2.834 (0.8763)

55. Secondary Outcome

Title	Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI	2 0.6%	2 0.6%
INI	6 1.9%	0 0%
NNRTI	5 1.6%	3 1%

56. Secondary Outcome

Title	Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Description	Blood samples will be collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK population includes all participants who received CAB and / or RPV and underwent PK sampling during the study, and provided CAB and /or RPV plasma concentration data.
Time Frame	Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA
Arm/Group Description	Participants received IM injections of CAB LA 400 mg every four weeks through Week 52.
Measure Participants	308
Pre-dose, Week 8, n=252	1.2277
Pre-dose, Week 12, n=261	1.6925
Pre-dose, Week 16, n=248	1.9533
Pre-dose, Week 20, n=233	2.1036
Pre-dose, Week 24, n=234	2.2537
Pre-dose, Week 28, n=232	2.4300
Pre-dose, Week 32, n=219	2.4483
Pre-dose, Week 36, n=209	2.4681
Pre-dose, Week 40, n=209	2.5126
Pre-dose, Week 44, n=221	2.7748
Pre-dose, Week 48, n=217	2.8378

57. Secondary Outcome

Title	Ctrough for RPV LA Evaluable
Description	Blood samples will be collected at indicated time points for PK analysis of RPV LA.
Time Frame	Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	RPV LA
Arm/Group Description	Participants received IM injections of RPV LA 600 mg every four weeks through Week 52.
Measure Participants	308
Pre-dose, Week 8, n=251	38.58
Pre-dose, Week 12, n=261	47.00
Pre-dose, Week 16, n=247	53.87
Pre-dose, Week 20, n=233	54.14
Pre-dose, Week 24, n=231	61.26
Pre-dose, Week 28, n=232	66.53
Pre-dose, Week 32, n=218	70.93
Pre-dose, Week 36, n=209	73.00
Pre-dose, Week 40, n=208	76.24
Pre-dose, Week 44, n=223	83.65
Pre-dose, Week 48, n=216	90.28

58. Secondary Outcome

Title	Area Under the Curve (AUC) for CAB LA
Description	AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for CAB LA.
Time Frame	Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41

Outcome Measure Data

Analysis Population Description

PK population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA
Arm/Group Description	Participants received IM injections of CAB LA 400 mg every four weeks through Week 52.
Measure Participants	303
Geometric Mean (95% Confidence Interval) [Hours*microgram per milliliter]	2324.29

59. Secondary Outcome

Title	AUC for RPV LA
Description	AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for RPV LA.
Time Frame	Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41

Outcome Measure Data

Analysis Population Description

PK population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	RPV LA
Arm/Group Description	Participants received IM injections of RPV LA 900 mg every four weeks through Week 52.
Measure Participants	303
Geometric Mean (95% Confidence Interval) [Hours*nanogram per milliliter]	67119.84

60. Secondary Outcome

Title	Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41
Description	Blood samples will be collected at indicated time points for PK analysis of CAB LA.
Time Frame	Week 41- 1 Week post dose

Outcome Measure Data

Analysis Population Description

PK population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA
Arm/Group Description	Participants received IM injections of CAB LA 400 mg every four weeks through Week 52.
Measure Participants	251
Geometric Mean (95% Confidence Interval) [Micrograms per milliliter]	3.3862

61. Secondary Outcome

Title	Cmax in Plasma for RPV LA Evaluable at Week 41
Description	Blood samples will be collected at indicated time points for PK analysis of RPV LA.
Time Frame	Week 41- 1 Week post dose

Outcome Measure Data

Analysis Population Description

PK population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	RPV LA
Arm/Group Description	Participants received IM injections of RPV LA 600 mg every four weeks through Week 52.
Measure Participants	251
Geometric Mean (95% Confidence Interval) [Nanograms per milliliter]	110.36

62. Secondary Outcome

Title	Percentage of Participants With a Virologic Failure Using Snapshot Algorithm by Baseline Third Agent
Description	Percentage of participants with virologic failure endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA >=50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, n=51, 54	2.0 0.6%	0 0%
INI, n=102, 99	0 0%	2.0 0.6%
NNRTI, n=155, 155	2.6 0.8%	0.6 0.2%

63. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent
Description	Percentage of participants with HIV-1 RNA < 50copies/mL endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA <50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, n=51, 54	92 29.9%	94 30.5%
INI, n=102, 99	94 30.5%	96 31.2%
NNRTI, n=155, 155	92 29.9%	95 30.8%

64. Secondary Outcome

Title	Number of Participants With Severity of Adverse Events by Baseline Third Agents
Description	Severity of AEs were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Grade 1	22 7.1%	20 6.5%
PI, Grade 2	20 6.5%	11 3.6%
PI, Grade 3	4 1.3%	4 1.3%
PI, Grade 4	1 0.3%	0 0%
PI, Grade 5	0 0%	1 0.3%
INI, Grade 1	40 13%	40 13%
INI, Grade 2	50 16.2%	23 7.5%
INI, Grade 3	8 2.6%	3 1%
INI, Grade 4	1 0.3%	2 0.6%
INI, Grade 5	0 0%	0 0%
NNRTI, Grade 1	39 12.7%	55 17.9%
NNRTI, Grade 2	88 28.6%	47 15.3%
NNRTI, Grade 3	15 4.9%	12 3.9%
NNRTI, Grade 4	6 1.9%	2 0.6%
NNRTI, Grade 5	0 0%	0 0%

65. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK
Description	Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST and CK to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, ALT, Week 4, n=51, 53	9.4 (17.93)	1.1 (9.99)
PI, ALT, Week 8, n=34, 53	7.9 (17.19)	0.9 (7.20)
PI, ALT, Week 12, n=50, 52	5.3 (17.31)	1.4 (9.76)
PI, ALT, Week 16, n=48, 53	6.5 (20.92)	1.4 (8.75)
PI, ALT, Week 20, n=46, 53	4.9 (18.06)	0.3 (7.34)
PI, ALT, Week 24, n=47, 53	4.1 (14.42)	0.5 (7.30)
PI, ALT, Week 28, n=42, 53	2.6 (11.47)	0.8 (7.46)
PI, ALT, Week 32, n=45, 51	3.5 (14.88)	0.5 (7.36)
PI, ALT, Week 36, n=44, 50	3.3 (13.55)	2.0 (9.78)
PI, ALT, Week 40, n=42, 51	5.4 (17.81)	1.1 (10.52)
PI, ALT, Week 44, n=47, 51	4.0 (15.83)	0.9 (11.97)
PI, ALT, Week 48, n=43, 50	2.9 (10.69)	0.5 (8.04)
INI, ALT, Week 4, n=99, 97	1.7 (15.15)	0.7 (7.20)
INI, ALT, Week 8, n=73, 98	3.3 (18.20)	5.4 (50.20)
INI, ALT, Week 12, n=99, 95	-1.0 (12.48)	1.7 (10.63)
INI, ALT, Week 16, n=93, 96	-1.8 (12.27)	-0.1 (8.58)
INI, ALT, Week 20, n=93, 97	-1.9 (13.60)	-0.5 (9.38)
INI, ALT, Week 24, n=94, 95	0.6 (17.33)	0.1 (9.95)
INI, ALT, Week 28, n=89, 93	-2.4 (9.70)	-0.4 (12.31)
INI, ALT, Week 32, n=93, 95	-1.8 (12.87)	-0.3 (7.79)
INI, ALT, Week 36, n=94, 95	1.5 (35.82)	-0.4 (8.79)
INI, ALT, Week 40, n=90, 95	5.0 (59.10)	-0.6 (9.62)
INI, ALT, Week 44, n=91, 94	-1.6 (13.90)	-0.4 (7.91)
INI, ALT, Week 48, n=91, 95	-0.2 (15.17)	-0.8 (7.41)
NNRTI, ALT, Week 4, n=151, 153	-2.6 (9.82)	-0.7 (10.80)
NNRTI, ALT, Week 8, n=122, 152	-2.9 (11.62)	-0.8 (12.06)
NNRTI, ALT, Week 12, n=146, 152	9.5 (160.61)	-0.8 (12.66)
NNRTI, ALT, Week 16, n=143, 149	-1.3 (26.21)	-1.6 (11.39)
NNRTI, ALT, Week 20, n=138, 152	-2.0 (28.04)	-2.0 (12.61)
NNRTI, ALT, Week 24, n=143, 151	2.6 (85.48)	-1.3 (11.85)
NNRTI, ALT, Week 28, n=136, 150	-4.5 (11.46)	-0.5 (14.03)
NNRTI, ALT, Week 32, n=137, 148	-3.8 (14.93)	-0.9 (14.33)
NNRTI, ALT, Week 36, n=135, 147	-3.8 (12.44)	-0.1 (12.48)
NNRTI, ALT, Week 40, n=138, 147	-3.8 (13.48)	-0.4 (13.47)
NNRTI, ALT, Week 44, n=137, 148	-4.7 (12.67)	-0.4 (14.67)
NNRTI, ALT, Week 48, n=131, 147	-4.6 (12.38)	-0.9 (12.75)
PI, ALP, Week 4, n=51, 53	-3.5 (11.63)	-2.9 (8.07)
PI, ALP, Week 8, n=34, 53	-2.1 (24.59)	0.2 (11.37)
PI, ALP, Week 12, n=50, 52	-5.7 (14.40)	0.9 (10.22)
PI, ALP, Week 16, n=48, 53	-7.3 (17.09)	0.6 (8.68)
PI, ALP, Week 20, n=46, 53	-6.8 (16.71)	0.1 (10.70)
PI, ALP, Week 24, n=47, 53	-7.5 (17.90)	-0.4 (7.67)
PI, ALP, Week 28, n=42, 53	-7.3 (17.23)	3.0 (9.69)
PI, ALP, Week 32, n=45, 51	-9.3 (16.47)	-0.7 (8.50)
PI, ALP, Week 36, n=44, 50	-10.2 (18.52)	0.6 (13.52)
PI, ALP, Week 40, n=42, 51	-8.7 (17.37)	-1.4 (8.79)
PI, ALP, Week 44, n=47, 51	-11.5 (17.49)	-0.9 (9.05)
PI, ALP, Week 48, n=43, 50	-8.0 (16.05)	-0.2 (9.08)
INI, ALP, Week 4, n=99, 97	-0.5 (10.59)	-0.9 (7.92)
INI, ALP, Week 8, n=73, 98	-1.8 (8.55)	4.9 (33.17)
INI, ALP, Week 12, n=99, 95	-1.6 (8.57)	3.5 (19.97)
INI, ALP, Week 16, n=93, 96	-1.7 (10.53)	-0.2 (10.93)
INI, ALP, Week 20, n=93, 97	-2.0 (10.23)	-0.4 (7.93)
INI, ALP, Week 24, n=94, 95	-1.4 (10.23)	-0.6 (8.25)
INI, ALP, Week 28, n=89, 93	-2.1 (10.83)	-0.8 (8.80)
INI, ALP, Week 32, n=93, 95	-1.6 (11.08)	-2.0 (8.23)
INI, ALP, Week 36, n=94, 95	-2.4 (12.03)	-2.2 (9.41)
INI, ALP, Week 40, n=90, 95	-0.9 (13.77)	-1.9 (9.33)
INI, ALP, Week 44, n=91, 94	-2.6 (13.69)	-0.4 (11.60)
INI, ALP, Week 48, n=91, 95	-1.9 (13.29)	-1.2 (10.26)
NNRTI, ALP, Week 4, n=151, 153	-10.4 (12.81)	-2.7 (9.60)
NNRTI, ALP, Week 8, n=122, 152	-10.9 (16.50)	-1.0 (10.77)
NNRTI, ALP, Week 12, n=146, 152	-13.0 (26.62)	-0.7 (11.04)
NNRTI, ALP, Week 16, n=143, 149	-15.7 (22.52)	-1.0 (10.54)
NNRTI, ALP, Week 20, n=138, 152	-14.9 (22.35)	-1.8 (13.77)
NNRTI, ALP, Week 24, n=143, 151	-14.5 (21.88)	0.4 (12.75)
NNRTI, ALP, Week 28, n=136, 150	-16.2 (21.66)	-1.0 (13.18)
NNRTI, ALP, Week 32, n=137, 148	-15.8 (21.98)	-1.8 (13.63)
NNRTI, ALP, Week 36, n=135, 147	-16.1 (23.60)	-1.0 (11.86)
NNRTI, ALP, Week 40, n=138, 147	-17.2 (22.83)	-0.4 (13.19)
NNRTI, ALP, Week 44, n=137, 148	-17.3 (23.32)	-0.8 (13.20)
NNRTI, ALP, Week 48, n=131, 147	-18.0 (27.97)	0.2 (14.69)
PI, AST, Week 4, n=51, 53	3.8 (9.18)	2.3 (16.78)
PI, AST, Week 8, n=34, 53	5.1 (8.35)	-0.1 (4.60)
PI, AST, Week 12, n=50, 52	2.7 (11.49)	1.7 (7.21)
PI, AST, Week 16, n=48, 53	3.9 (16.81)	1.8 (10.69)
PI, AST, Week 20, n=46, 53	4.1 (20.85)	0.5 (4.29)
PI, AST, Week 24, n=47, 53	1.5 (7.76)	1.6 (9.93)
PI, AST, Week 28, n=42, 53	2.9 (8.86)	1.9 (7.45)
PI, AST, Week 32, n=45, 51	3.1 (14.13)	0.6 (4.93)
PI, AST, Week 36, n=44, 50	1.7 (8.04)	1.9 (6.24)
PI, AST, Week 40, n=42, 51	5.7 (24.61)	0.5 (6.05)
PI, AST, Week 44, n=47, 51	1.7 (9.71)	1.4 (11.60)
PI, AST, Week 48, n=43, 50	1.7 (7.09)	2.1 (8.74)
INI, AST, Week 4, n=99, 97	0.0 (15.36)	-0.1 (6.29)
INI, AST, Week 8, n=73, 98	3.3 (25.01)	1.2 (21.48)
INI, AST, Week 12, n=99, 95	-1.3 (14.22)	0.8 (7.35)
INI, AST, Week 16, n=93, 96	-2.1 (12.73)	0.1 (10.96)
INI, AST, Week 20, n=93, 97	-1.7 (13.77)	-0.9 (12.67)
INI, AST, Week 24, n=94, 95	-0.4 (14.88)	-0.2 (10.40)
INI, AST, Week 28, n=89, 93	-1.4 (7.74)	-0.9 (13.48)
INI, AST, Week 32, n=93, 95	-2.1 (13.06)	-0.8 (10.01)
INI, AST, Week 36, n=94, 95	-0.7 (17.34)	-1.1 (11.70)
INI, AST, Week 40, n=90, 95	1.0 (20.11)	-0.4 (13.96)
INI, AST, Week 44, n=91, 94	1.0 (24.54)	-0.7 (10.69)
INI, AST, Week 48, n=91, 95	0.4 (16.57)	0.2 (11.91)
NNRTI, AST, Week 4, n=151, 153	-1.9 (11.09)	-0.5 (8.73)
NNRTI, AST, Week 8, n=122, 152	-1.3 (18.14)	-0.9 (8.31)
NNRTI, AST, Week 12, n=146, 152	4.7 (91.54)	0.0 (10.08)
NNRTI, AST, Week 16, n=143, 149	0.3 (21.80)	-1.0 (8.37)
NNRTI, AST, Week 20, n=138, 152	-1.2 (17.47)	-0.7 (9.09)
NNRTI, AST, Week 24, n=143, 150	-0.1 (31.53)	-0.4 (8.87)
NNRTI, AST, Week 28, n=136, 150	-2.8 (9.02)	0.4 (10.70)
NNRTI, AST, Week 32, n=137, 148	-2.0 (18.27)	1.5 (16.84)
NNRTI, AST, Week 36, n=135, 147	-2.5 (10.33)	0.2 (9.00)
NNRTI, AST, Week 40, n=138, 147	-2.7 (11.14)	0.1 (9.40)
NNRTI, AST, Week 44, n=137, 148	-3.4 (10.38)	0.1 (11.20)
NNRTI, AST, Week 48, n=131, 147	-2.9 (10.87)	0.5 (10.60)
PI, CK, Week 4, n=51, 53	8.6 (182.21)	133.5 (907.82)
PI, CK, Week 8, n=34, 53	67.9 (176.14)	23.5 (174.40)
PI, CK, Week 12, n=50, 52	3.1 (162.71)	57.9 (406.52)
PI, CK, Week 16, n=48, 53	19.4 (253.86)	16.3 (66.34)
PI, CK, Week 20, n=46, 53	103.6 (696.54)	6.8 (72.86)
PI, CK, Week 24, n=47, 53	-3.0 (181.03)	18.2 (86.69)
PI, CK, Week 28, n=42, 53	60.3 (299.83)	13.5 (93.14)
PI, CK, Week 32, n=45, 51	157.1 (988.65)	1.5 (64.94)
PI, CK, Week 36, n=44, 50	-9.0 (191.25)	22.3 (62.09)
PI, CK, Week 40, n=42, 51	193.7 (1188.89)	0.3 (48.24)
PI, CK, Week 44, n=47, 51	-6.3 (185.69)	4.8 (62.91)
PI, CK, Week 48, n=43, 50	-1.0 (158.33)	72.9 (478.94)
INI, CK, Week 4, n=99, 97	-32.7 (717.86)	-17.9 (260.84)
INI, CK, Week 8, n=73, 98	95.6 (801.75)	-58.0 (577.11)
INI, CK, Week 12, n=99, 95	-16.1 (852.44)	-23.9 (304.61)
INI, CK, Week 16, n=93, 96	-59.5 (629.54)	-1.9 (686.38)
INI, CK, Week 20, n=93, 97	-55.7 (623.92)	-58.1 (622.84)
INI, CK, Week 24, n=94, 95	-63.1 (549.02)	-40.7 (588.24)
INI, CK Week 28, n=89, 93	-17.4 (224.35)	-27.4 (759.07)
INI, CK, Week 32, n=93, 95	-82.8 (587.51)	-42.1 (637.00)
INI, CK, Week 36, n=94, 95	-76.1 (602.03)	-60.9 (603.48)
INI, CK, Week 40, n=90, 95	40.3 (864.00)	-36.2 (609.80)
INI, CK, Week 44, n=91, 94	199.8 (2043.35)	-60.2 (576.84)
INI, CK, Week 48, n=91, 95	20.5 (861.55)	-25.0 (653.03)
NNRTI, CK, Week 4, n=151, 153	18.2 (502.12)	26.0 (214.58)
NNRTI, CK, Week 8, n=122, 152	108.2 (1339.52)	-3.6 (108.28)
NNRTI, CK, Week 12, n=146, 152	21.9 (440.81)	24.5 (222.26)
NNRTI, CK, Week 16, n=143, 149	139.9 (1121.08)	7.0 (189.21)
NNRTI, CK, Week 20, n=138, 152	65.5 (656.11)	1.6 (114.05)
NNRTI, CK, Week 24, n=143, 151	24.1 (606.47)	17.7 (167.38)
NNRTI, CK, Week 28, n=136, 150	-10.9 (169.29)	53.2 (462.07)
NNRTI, CK, Week 32, n=137, 148	31.3 (650.27)	94.0 (665.17)
NNRTI, CK, Week 36, n=135, 147	19.0 (440.56)	10.3 (135.08)
NNRTI, CK, Week 40, n=138, 147	-7.7 (237.00)	22.6 (195.23)
NNRTI, CK, Week 44, n=137, 148	-35.4 (183.15)	14.9 (173.39)
NNRTI, CK, Week 48, n=131, 147	-15.1 (212.52)	27.3 (272.59)

66. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin
Description	Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Week 4, n=51, 53	0.2 (2.21)	-0.2 (2.41)
PI, Week 8, n=34, 53	0.7 (2.73)	-0.1 (2.74)
PI, Week 12, n=50, 52	-0.2 (2.67)	-0.3 (2.81)
PI, Week 16, n=48, 53	-0.2 (2.77)	-0.8 (2.72)
PI, Week 20, n=46, 53	-0.4 (2.35)	-0.8 (2.82)
PI, Week 24, n=47, 53	-0.6 (2.24)	-0.8 (2.40)
PI, Week 28, n=42, 53	-0.6 (2.26)	-1.4 (2.08)
PI, Week 32, n=45, 51	-0.7 (2.39)	-0.5 (2.42)
PI, Week 36, n=44, 50	-0.6 (2.44)	-0.9 (2.48)
PI, Week 40, n=42, 51	-0.1 (2.72)	-0.5 (2.37)
PI, Week 44, n=47, 51	-0.5 (2.15)	-0.5 (2.60)
PI, Week 48, n=43, 50	-0.3 (2.74)	-0.1 (2.44)
INI, Week 4, n=99, 97	-0.4 (2.56)	-0.9 (2.62)
INI, Week 8, n=73, 98	-0.5 (2.59)	-1.0 (2.89)
INI, Week 12, n=99, 95	-0.3 (2.92)	-0.5 (2.59)
INI, Week 16, n=93, 96	-0.5 (2.78)	-1.1 (2.80)
INI, Week 20, n=93, 97	-0.7 (2.71)	-0.7 (2.77)
INI, Week 24, n=94, 95	-0.8 (2.86)	-1.0 (2.74)
INI, Week 28, n=89, 93	-0.3 (2.55)	-1.1 (2.87)
INI, Week 32, n=93, 95	-0.2 (2.70)	-1.3 (2.77)
INI, Week 36, n=94, 95	-0.8 (2.67)	-1.1 (2.54)
INI, Week 40, n=90, 95	-0.3 (2.40)	-1.3 (2.84)
INI, Week 44, n=91, 94	-0.5 (2.77)	-1.0 (2.76)
INI, Week 48, n=91, 95	-0.1 (2.69)	-0.5 (2.69)
NNRTI, Week 4, n=151, 153	-0.8 (2.70)	-0.3 (2.42)
NNRTI, Week 8, n=122, 152	-0.4 (2.83)	-0.6 (2.53)
NNRTI, Week 12, n=146, 152	-0.8 (2.59)	-0.3 (2.61)
NNRTI, Week 16, n=143, 149	-0.8 (2.79)	-0.7 (2.63)
NNRTI, Week 20, n=138, 152	-0.9 (2.96)	-0.9 (2.33)
NNRTI, Week 24, n=143, 151	-0.7 (2.73)	-0.7 (2.57)
NNRTI, Week 28, n=136, 150	-0.9 (2.72)	-0.9 (2.34)
NNRTI, Week 32, n=137, 148	-0.9 (2.94)	-1.0 (2.45)
NNRTI, Week 36, n=135, 147	-1.0 (2.83)	-0.8 (2.79)
NNRTI, Week 40, n=138, 147	-0.7 (2.54)	-1.0 (2.52)
NNRTI, Week 44, n=137, 148	-0.3 (2.60)	-0.8 (2.22)
NNRTI, Week 48, n=131, 147	-0.6 (2.57)	-0.5 (2.49)

67. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Description	Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Bilirubin, Week 4, n=51, 53	-9.0 (20.62)	0.3 (6.95)
PI, Bilirubin, Week 8, n=34, 53	-6.6 (13.76)	0.1 (5.76)
PI, Bilirubin, Week 12, n=50, 52	-10.2 (20.18)	1.7 (7.11)
PI, Bilirubin, Week 16, n=48, 53	-10.0 (20.13)	0.6 (6.42)
PI, Bilirubin, Week 20, n=46, 53	-9.2 (20.21)	1.5 (12.45)
PI, Bilirubin, Week 24, n=47, 53	-9.6 (20.64)	2.7 (11.87)
PI, Bilirubin, Week 28, n=42, 53	-10.0 (22.42)	0.9 (7.70)
PI, Bilirubin, Week 32, n=45, 51	-8.9 (21.34)	2.7 (8.64)
PI, Bilirubin, Week 36, n=44, 50	-10.5 (21.75)	2.6 (7.35)
PI, Bilirubin, Week 40, n=42, 51	-11.0 (22.20)	3.5 (12.74)
PI, Bilirubin, Week 44, n=47, 51	-9.6 (20.32)	3.7 (9.10)
PI, Bilirubin, Week 48, n=43, 50	-10.7 (21.77)	2.3 (5.23)
INI, Bilirubin, Week 4, n=99, 97	0.2 (3.92)	-0.7 (3.93)
INI, Bilirubin, Week 8, n=73, 98	0.4 (3.96)	0.9 (12.43)
INI, Bilirubin, Week 12, n=99, 95	0.6 (4.41)	-0.5 (4.69)
INI, Bilirubin, Week 16, n=93, 96	0.6 (4.30)	-0.2 (4.35)
INI, Bilirubin, Week 20, n=93, 97	0.9 (4.08)	-0.5 (4.32)
INI, Bilirubin, Week 24, n=94, 94	0.2 (3.72)	-0.5 (3.88)
INI, Bilirubin, Week 28, n=89, 93	1.1 (3.58)	-0.4 (4.85)
INI, Bilirubin, Week 32, n=93, 95	0.7 (4.67)	-1.1 (4.54)
INI, Bilirubin, Week 36, n=94, 95	0.5 (4.07)	-0.6 (4.62)
INI, Bilirubin, Week 40, n=90, 95	0.6 (4.28)	-1.0 (4.26)
INI, Bilirubin, Week 44, n=91, 94	0.9 (4.34)	-0.7 (4.72)
INI, Bilirubin, Week 48, n=91, 95	1.1 (3.72)	-0.9 (3.96)
NNRTI, Bilirubin, Week 4, n=151, 153	1.4 (3.87)	-0.4 (2.85)
NNRTI, Bilirubin, Week 8, n=122, 152	1.4 (3.84)	-0.4 (2.43)
NNRTI, Bilirubin, Week 12, n=146, 152	2.0 (4.69)	-0.2 (3.01)
NNRTI, Bilirubin, Week 16, n=143, 149	3.3 (14.12)	-0.5 (2.66)
NNRTI, Bilirubin, Week 20, n=138, 152	2.1 (4.90)	-0.1 (2.81)
NNRTI, Bilirubin, Week 24, n=143, 151	1.8 (3.91)	-0.3 (2.84)
NNRTI, Bilirubin, Week 28, n=136, 150	2.4 (4.11)	-0.4 (3.04)
NNRTI, Bilirubin, Week 32, n=137, 148	2.2 (4.76)	-0.3 (2.57)
NNRTI, Bilirubin, Week 36, n=135, 147	1.8 (4.14)	-0.2 (2.61)
NNRTI, Bilirubin, Week 40, n=138, 147	2.2 (4.43)	-0.2 (2.61)
NNRTI, Bilirubin, Week 44, n=137, 148	2.0 (4.15)	-0.1 (2.72)
NNRTI, Bilirubin, Week 48, n=131, 147	2.2 (4.59)	0.1 (2.98)
PI, Direct bilirubin, Week 4, n=51, 53	-1.2 (2.34)	0.3 (1.40)
PI, Direct bilirubin, Week 8, n=34, 53	-0.9 (2.16)	-0.1 (1.44)
PI, Direct bilirubin, Week 12, n=50, 52	-1.6 (2.16)	0.3 (1.39)
PI, direct bilirubin, Week 16, n=48, 53	-1.7 (2.12)	0.0 (1.30)
PI, Direct bilirubin, Week 20, n=46, 53	-1.5 (2.27)	0.0 (1.86)
PI, Direct bilirubin, Week 24, n=47, 53	-1.4 (2.27)	0.2 (1.72)
PI, Direct bilirubin, Week 28, n=42, 53	-1.6 (2.43)	-0.3 (1.52)
PI, Direct bilirubin, Week 32, n=45, 51	-1.4 (2.48)	0.2 (1.74)
PI, Direct bilirubin, Week 36, n=44, 50	-1.8 (2.29)	0.2 (1.49)
PI, Direct bilirubin, Week 40, n=42, 51	-1.8 (2.29)	0.2 (1.43)
PI, Direct bilirubin, Week 44, n=47, 51	-1.5 (2.22)	0.3 (1.52)
PI, Direct bilirubin, Week 48, n=43, 50	-1.5 (2.35)	0.2 (1.36)
INI, Direct bilirubin, Week 4, n=99, 97	0.0 (1.11)	0.0 (1.19)
INI, Direct bilirubin, Week 8, n=73, 98	0.0 (1.13)	0.7 (6.76)
INI, Direct bilirubin, Week 12, n=99, 95	0.0 (1.14)	0.0 (1.29)
INI, Direct bilirubin, Week 16, n=93, 96	0.0 (1.14)	-0.3 (1.06)
INI, Direct bilirubin, Week 20, n=93, 97	-0.2 (0.96)	-0.2 (1.23)
INI, Direct bilirubin, Week 24, n=94, 94	-0.1 (1.07)	-0.3 (1.16)
INI, Direct bilirubin, Week 28, n=89, 93	-0.1 (0.97)	-0.2 (1.30)
INI, Direct bilirubin, Week 32, n=93, 95	-0.2 (1.24)	-0.4 (1.15)
INI, Direct bilirubin, Week 36, n=94, 95	-0.2 (1.33)	-0.3 (1.18)
INI, Direct bilirubin, Week 40, n=90, 95	-0.1 (1.10)	-0.4 (1.24)
INI, Direct bilirubin. Week 44, n=91, 94	0.0 (1.14)	-0.3 (1.11)
INI, Direct bilirubin, Week 48, n=91, 95	0.0 (1.01)	-0.1 (1.28)
NNRTI, Direct bilirubin, Week 4, n=151, 153	0.1 (1.14)	0.1 (1.12)
NNRTI, Direct bilirubin, Week 8, n=122, 152	0.1 (1.24)	0.0 (1.03)
NNRTI, Direct bilirubin, Week 12, n=146, 152	0.2 (1.38)	0.0 (1.08)
NNRTI, Direct bilirubin, Week 16, n=143, 149	0.7 (6.82)	-0.1 (1.09)
NNRTI, Direct bilirubin, Week 20, n=138, 152	0.1 (1.32)	-0.2 (1.08)
NNRTI, Direct bilirubin, Week 24, n=143, 151	0.1 (1.34)	-0.1 (1.06)
NNRTI, Direct bilirubin, Week 28, n=136, 150	0.1 (1.29)	-0.2 (1.19)
NNRTI, Direct bilirubin, Week 32, n=137, 148	0.0 (1.31)	-0.2 (1.06)
NNRTI, Direct bilirubin, Week 36, n=135, 147	0.0 (1.47)	-0.2 (1.09)
NNRTI, Direct bilirubin, Week 40, n=138, 147	0.0 (1.55)	-0.2 (1.01)
NNRTI, Direct bilirubin, Week 44, n=137, 148	0.1 (1.28)	-0.1 (1.08)
NNRTI, Direct bilirubin, Week 48, n=131, 147	0.1 (1.27)	0.0 (1.16)
PI, Creatinine, Week 4, n=51, 53	1.46 (7.726)	2.16 (6.737)
PI, Creatinine, Week 8, n=34, 53	0.87 (7.777)	1.17 (5.605)
PI, Creatinine, Week 12, n=50, 52	-1.66 (8.971)	3.01 (5.406)
PI, Creatinine, Week 16, n=48, 53	-0.90 (8.658)	2.88 (5.918)
PI, Creatinine, Week 20, n=46, 53	1.63 (8.709)	5.00 (9.336)
PI, Creatinine, Week 24, n=47, 53	0.48 (7.143)	2.47 (6.821)
PI, Creatinine, Week 28, n=42, 53	3.06 (9.741)	3.05 (6.908)
PI, Creatinine, Week 32, n=45, 51	2.29 (10.124)	3.79 (6.540)
PI, Creatinine, Week 36, n=44, 50	2.20 (7.347)	2.36 (6.291)
PI, Creatinine, Week 40, n=42, 51	1.10 (9.155)	3.46 (6.166)
PI, Creatinine, Week 44, n=47, 51	3.01 (8.981)	2.73 (6.169)
PI, Creatinine, Week 48, n=43, 50	4.41 (10.009)	1.86 (5.575)
INI, Creatinine, Week 4, n=99, 95	-1.61 (8.848)	1.64 (10.592)
INI, Creatinine, Week 8, n=73, 98	-3.93 (10.030)	1.56 (9.444)
INI, Creatinine, Week 12, n=99, 95	-2.47 (10.973)	3.03 (10.203)
INI, Creatinine, Week 16, n=93, 96	-3.93 (9.000)	0.36 (8.651)
INI, Creatinine, Week 20, n=93, 97	-3.73 (9.101)	0.86 (9.608)
INI, Creatinine, Week 24, n=94, 94	-4.25 (8.281)	0.87 (10.493)
INI, Creatinine, Week 28, n=89, 93	-3.54 (10.713)	0.92 (10.086)
INI, Creatinine, Week 32, n=93, 95	-3.48 (10.591)	0.86 (9.754)
INI, Creatinine, Week 36, n=94, 95	-4.31 (10.360)	1.34 (9.369)
INI, Creatinine, Week 40, n=90, 95	-3.08 (9.913)	1.66 (10.272)
INI, Creatinine, Week 44, n=91, 94	-3.33 (9.165)	0.98 (10.443)
INI, Creatinine, Week 48, n=91, 95	-2.99 (9.442)	0.47 (9.602)
NNRTI, Creatinine, Week 4, n=151, 153	2.86 (7.456)	1.77 (6.484)
NNRTI, Creatinine, Week 8, n=122, 152	0.86 (8.263)	1.05 (6.790)
NNRTI, Creatinine, Week 12, n=146, 152	1.47 (7.928)	0.44 (6.096)
NNRTI, Creatinine, Week 16, n=143, 149	1.67 (8.934)	1.98 (8.475)
NNRTI, Creatinine, Week 20, n=138, 152	3.04 (8.836)	1.27 (7.023)
NNRTI, Creatinine, Week 24, n=143, 151	4.42 (14.819)	1.28 (6.553)
NNRTI, Creatinine, Week 28, n=136, 150	3.61 (10.627)	1.50 (7.483)
NNRTI, Creatinine, Week 32, n=137, 148	2.26 (9.033)	2.01 (7.811)
NNRTI, Creatinine, Week 36, n=135, 147	2.98 (10.596)	1.54 (7.354)
NNRTI, Creatinine, Week 40, n=138, 147	3.39 (9.496)	0.99 (7.471)
NNRTI, Creatinine, Week 44, n=137, 148	3.24 (8.892)	1.21 (6.686)
NNRTI, Creatinine, Week 48, n=131, 147	3.84 (11.860)	0.69 (7.241)

68. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance
Description	Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Week 4, n=51, 53	-2.2 (9.77)	-2.8 (8.02)
PI, Week 8, n=34, 53	-1.1 (10.19)	-1.3 (6.58)
PI, Week 12, n=50, 52	2.2 (11.04)	-3.7 (6.99)
PI, Week 16, n=48, 53	0.9 (11.02)	-3.1 (7.63)
PI, Week 20, n=46, 53	-2.2 (10.80)	-5.0 (9.26)
PI, Week 24, n=47, 53	-1.0 (8.60)	-3.8 (8.51)
PI, Week 28, n=42, 53	-4.2 (11.82)	-4.0 (8.46)
PI, Week 32, n=45, 51	-3.2 (12.30)	-5.2 (7.56)
PI, Week 36, n=44, 50	-3.8 (8.68)	-3.6 (8.08)
PI, Week 40, n=42, 51	-2.4 (10.71)	-4.9 (7.25)
PI, Week 44, n=47, 51	-4.5 (10.63)	-4.2 (7.58)
PI, Week 48, n=43, 50	-5.6 (12.22)	-3.1 (6.54)
INI, Week 4, n=99, 95	1.0 (9.51)	-2.0 (11.28)
INI, Week 8, n=72, 98	3.9 (9.84)	-1.9 (9.28)
INI, Week 12, n=99, 93	2.1 (11.32)	-3.1 (9.60)
INI, Week 16, n=93, 96	3.6 (9.71)	-0.7 (8.59)
INI, Week 20, n=93, 97	3.5 (9.77)	-1.7 (9.58)
INI, Week 24, n=94, 94	3.9 (9.26)	-1.8 (10.38)
INI, Week 28, n=89, 93	3.1 (11.02)	-1.6 (9.55)
INI, Week 32, n=92, 95	3.0 (10.40)	-2.0 (9.69)
INI, Week 36, n=94, 95	3.7 (11.19)	-2.3 (9.30)
INI, Week 40, n=89, 95	2.7 (10.45)	-2.6 (10.14)
INI, Week 44, n=91, 94	2.6 (9.88)	-1.6 (10.90)
INI, Week 48, n=90, 94	3.0 (9.74)	-1.6 (9.73)
NNRTI, Week 4, n=151, 153	-3.4 (9.06)	-2.3 (8.10)
NNRTI, Week 8, n=121, 152	-1.1 (9.35)	-1.3 (7.72)
NNRTI, Week 12, n=146, 152	-1.7 (8.90)	-0.5 (7.03)
NNRTI, Week 16, n=143, 148	-1.8 (10.60)	-2.3 (9.06)
NNRTI, Week 20, n=138, 152	-3.7 (9.64)	-1.9 (7.41)
NNRTI, Week 24, n=142, 151	-4.3 (10.67)	-2.0 (7.67)
NNRTI, Week 28, n=136, 150	-4.3 (10.68)	-2.4 (8.67)
NNRTI, Week 32, n=137, 148	-3.3 (10.42)	-2.8 (8.80)
NNRTI, Week 36, n=135, 147	-3.8 (10.97)	-2.5 (8.16)
NNRTI, Week 40, n=137, 147	-4.4 (9.97)	-2.0 (8.90)
NNRTI, Week 44, n=136, 148	-4.4 (9.75)	-2.0 (7.45)
NNRTI, Week 48, n=131, 147	-5.2 (11.72)	-1.6 (8.25)

69. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase
Description	Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Week 4, n=51, 53	-2.2 (16.83)	1.2 (19.34)
PI, Week 8, n=34, 53	-2.6 (6.71)	2.5 (25.36)
PI, Week 12, n=49, 52	-1.4 (17.24)	-2.2 (15.95)
PI, Week 16, n=47, 53	-0.5 (18.71)	1.4 (17.40)
PI, Week 20, n=46, 53	-2.5 (17.90)	-0.6 (17.49)
PI, Week 24, n=47, 53	-2.0 (16.61)	-2.7 (16.30)
PI, Week 28, n=42, 53	-0.7 (18.60)	0.2 (16.18)
PI, Week 32, n=45, 51	-2.2 (19.27)	2.5 (18.35)
PI, Week 36, n=44, 50	-0.8 (17.96)	-1.2 (18.18)
PI, Week 40, n=42, 51	2.2 (26.77)	-1.8 (19.40)
PI, Week 44, n=47, 51	-1.2 (18.28)	1.4 (17.94)
PI, Week 48, n=43, 50	-1.5 (19.38)	-1.3 (15.73)
INI, Week 4, n=99, 97	8.1 (34.32)	3.8 (30.44)
INI, Week 8, n=72, 98	0.7 (9.79)	-0.5 (14.46)
INI, Week 12, n=99, 93	4.3 (17.70)	1.8 (21.29)
INI, Week 16, n=93, 97	4.4 (22.42)	0.6 (16.13)
INI, Week 20, n=94, 97	2.5 (17.23)	0.9 (17.07)
INI, Week 24, n=94, 95	2.2 (15.17)	2.2 (18.91)
INI, Week 28, n=89, 94	5.6 (28.06)	5.1 (24.20)
INI, Week 32, n=92, 95	3.2 (18.68)	5.4 (22.79)
INI, Week 36, n=94, 95	5.2 (21.04)	0.1 (13.82)
INI, Week 40, n=89, 95	3.5 (11.71)	1.7 (16.60)
INI, Week 44, n=91, 94	4.3 (21.59)	4.8 (23.54)
INI, Week 48, n=90, 94	5.0 (24.95)	3.9 (23.48)
NNRTI, Week 4, n=151, 153	5.7 (50.44)	0.1 (20.35)
NNRTI, Week 8, n=121, 152	2.6 (25.04)	1.5 (16.94)
NNRTI, Week 12, n=146, 152	3.0 (30.94)	-1.9 (17.59)
NNRTI, Week 16, n=145, 149	2.5 (27.82)	6.1 (40.62)
NNRTI, Week 20, n=138, 152	0.9 (13.53)	1.3 (37.14)
NNRTI, Week 24, n=142, 151	3.4 (24.81)	5.4 (28.22)
NNRTI, Week 28, n=136, 150	0.8 (24.38)	1.2 (15.79)
NNRTI, Week 32, n=137, 148	9.1 (78.96)	1.9 (21.30)
NNRTI, Week 36, n=135, 147	6.9 (68.07)	1.7 (19.14)
NNRTI, Week 40, n=138, 147	7.1 (43.53)	0.5 (17.62)
NNRTI, Week 44, n=136, 148	1.6 (24.46)	1.1 (20.52)
NNRTI, Week 48, n=131, 146	3.1 (32.54)	0.9 (16.60)

70. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48
Description	Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, CO2, Week 4, n=51, 53	1.3 (2.63)	0.7 (2.34)
PI, CO2, Week 8, n=34, 53	0.4 (2.36)	0.3 (2.65)
PI, CO2, Week 12, n=50, 52	0.7 (2.84)	0.2 (2.23)
PI, CO2, Week 16, n=48, 53	0.8 (2.60)	0.2 (2.32)
PI, CO2, Week 20, n=46, 53	0.9 (2.53)	0.0 (2.26)
PI, CO2, Week 24, n=47, 53	0.4 (2.23)	0.1 (1.94)
PI, CO2, Week 28, n=42, 53	0.6 (2.54)	-0.2 (2.37)
PI, CO2, Week 32, n=45, 51	0.5 (2.35)	-0.2 (2.36)
PI, CO2, Week 36, n=44, 50	0.5 (2.38)	-0.4 (1.98)
PI, CO2, Week 40, n=42, 51	0.5 (2.10)	0.3 (2.26)
PI, CO2, Week 44, n=47, 51	0.7 (2.29)	0.3 (2.18)
PI, CO2, Week 48, n=43, 50	0.9 (2.69)	-0.1 (1.87)
INI, CO2, Week 4, n=99, 97	1.0 (2.37)	0.8 (2.21)
INI, CO2, Week 8, n=73, 98	0.5 (2.29)	0.6 (2.46)
INI, CO2, Week 12, n=99, 95	0.4 (2.27)	0.3 (2.31)
INI, CO2, Week 16, n=93, 96	0.1 (2.56)	0.6 (2.53)
INI, CO2, Week 20, n=93, 97	0.1 (2.07)	0.7 (2.25)
INI, CO2, Week 24, n=94, 95	0.1 (2.32)	0.2 (2.49)
INI, CO2, Week 28, n=89, 93	-0.3 (2.30)	0.2 (2.41)
INI, CO2, Week 32, n=93, 95	0.2 (2.33)	0.1 (2.34)
INI, CO2, Week 36, n=94, 95	0.0 (2.36)	0.5 (2.58)
INI, CO2, Week 40, n=90, 95	0.5 (2.43)	0.3 (2.18)
INI, CO2, Week 44, n=91, 94	0.5 (2.36)	0.7 (2.45)
INI, CO2, Week 48, n=91, 95	0.1 (2.12)	0.3 (2.53)
NNRTI, CO2, Week 4, n=151, 153	0.9 (2.60)	0.7 (2.18)
NNRTI, CO2, Week 8, n=122, 152	0.4 (2.32)	0.8 (2.52)
NNRTI, CO2, Week 12, n=146, 152	0.5 (2.38)	0.4 (2.51)
NNRTI, CO2, Week 16, n=143, 149	0.3 (2.25)	0.5 (2.37)
NNRTI, CO2, Week 20, n=138, 152	0.1 (2.27)	0.2 (2.35)
NNRTI, CO2, Week 24, n=143, 150	0.3 (2.63)	0.3 (2.57)
NNRTI, CO2, Week 28, n=136, 150	0.1 (2.54)	0.2 (2.40)
NNRTI, CO2, Week 32, n=137, 148	-0.2 (2.39)	0.4 (2.27)
NNRTI, CO2, Week 36, n=135, 147	0.1 (2.38)	0.5 (2.37)
NNRTI, CO2, Week 40, n=138, 147	0.4 (2.64)	0.5 (2.38)
NNRTI, CO2, Week 44, n=137, 148	0.4 (2.35)	0.5 (2.01)
NNRTI, CO2, Week 48, n=131, 147	-0.1 (2.47)	0.3 (2.30)
PI, Chloride, Week 4, n=51, 53	0.5 (1.80)	0.5 (2.34)
PI, Chloride, Week 8, n=34, 53	0.2 (2.59)	0.7 (2.42)
PI, Chloride, Week 12, n=50, 52	0.5 (2.39)	0.8 (2.20)
PI, Chloride, Week 16, n=48, 53	0.5 (2.46)	1.0 (2.31)
PI, Chloride, Week 20, n=46, 53	0.8 (2.20)	0.7 (2.30)
PI, Chloride, Week 24, n=47, 53	1.1 (2.07)	1.3 (2.36)
PI, Chloride, Week 28, n=42, 53	1.5 (2.19)	1.2 (3.06)
PI, Chloride, Week 32, n=45, 51	0.9 (2.43)	0.9 (2.60)
PI, Chloride, Week 36, n=44, 50	1.0 (2.28)	1.0 (3.00)
PI, Chloride, Week 40, n=42, 51	1.3 (2.35)	1.1 (2.60)
PI, Chloride, Week 44, n=47, 51	1.1 (2.21)	1.1 (2.57)
PI, Chloride, Week 48, n=43, 50	0.5 (2.10)	0.9 (2.29)
INI, Chloride, Week 4, n=99, 97	0.3 (2.02)	0.5 (1.96)
INI, Chloride, Week 8, n=73, 98	0.2 (2.02)	0.1 (2.42)
INI, Chloride, Week 12, n=99, 95	0.4 (2.53)	0.5 (2.27)
INI, Chloride, Week 16, n=93, 96	0.9 (2.45)	0.7 (2.32)
INI, Chloride, Week 20, n=93, 97	1.0 (2.44)	0.2 (2.31)
INI, Chloride, Week 24, n=94, 95	0.6 (2.46)	0.5 (2.19)
INI, Chloride, Week 28, n=89, 93	0.8 (1.92)	0.3 (2.37)
INI, Chloride, Week 32, n=93, 95	0.7 (2.39)	0.7 (2.45)
INI, Chloride, Week 36, n=94, 95	0.8 (2.20)	0.5 (2.32)
INI, Chloride, Week 40, n=90, 95	0.7 (2.24)	0.4 (2.69)
INI, Chloride, Week 44, n=91, 94	0.7 (2.38)	0.5 (2.41)
INI, Chloride, Week 48, n=91, 95	0.4 (2.37)	-0.3 (2.36)
NNRTI, Chloride, Week 4, n=151, 153	0.4 (2.15)	0.6 (2.17)
NNRTI, Chloride, Week 8, n=122, 152	0.4 (2.05)	0.7 (1.91)
NNRTI, Chloride, Week 12, n=146, 152	0.4 (2.12)	0.5 (2.27)
NNRTI, Chloride, Week 16, n=143, 149	0.5 (2.37)	0.8 (2.20)
NNRTI, Chloride, Week 20, n=138, 152	0.7 (2.27)	1.1 (2.40)
NNRTI, Chloride, Week 24, n=143, 151	0.5 (2.60)	1.1 (2.24)
NNRTI, Chloride, Week 28, n=136, 150	0.8 (2.38)	1.3 (2.39)
NNRTI, Chloride, Week 32, n=137, 148	0.8 (2.44)	1.1 (2.15)
NNRTI, Chloride, Week 36, n=135, 147	1.0 (2.15)	1.1 (2.37)
NNRTI, Chloride, Week 40, n=138, 147	0.6 (2.20)	1.0 (2.84)
NNRTI, Chloride, Week 44, n=137, 148	0.6 (2.07)	1.0 (2.08)
NNRTI, Chloride, Week 48, n=131, 147	0.6 (2.45)	0.5 (2.36)
PI, Glucose, Week 4, n=43, 43	-0.08 (0.922)	0.32 (0.401)
PI, Glucose, Week 8, n=25, 41	0.17 (0.513)	0.22 (0.466)
PI, Glucose, Week 12, n=40, 42	0.03 (0.925)	0.27 (0.494)
PI, Glucose, Week 16, n=39, 43	0.11 (1.163)	0.28 (0.704)
PI, Glucose, Week 20, n=35, 41	-0.07 (1.058)	0.30 (0.799)
PI, Glucose, Week 24, n=38, 42	0.11 (0.705)	0.32 (0.636)
PI, Glucose, Week 28, n=32, 43	-0.03 (1.342)	0.16 (0.441)
PI, Glucose, Week 32, n=36, 41	0.23 (1.148)	0.29 (0.600)
PI, Glucose, Week 36, n=35, 41	-0.01 (1.014)	0.22 (0.483)
PI, Glucose, Week 40, n=34, 40	0.11 (1.035)	0.18 (0.497)
PI, Glucose, Week 44, n=40, 40	0.01 (1.008)	0.20 (0.278)
PI, Glucose, Week 48, n=39, 48	-0.01 (0.977)	0.11 (0.663)
INI, Glucose, Week 4, n=55, 52	0.30 (0.613)	0.07 (0.774)
INI, Glucose, Week 8, n=36, 57	0.12 (0.595)	0.21 (1.083)
INI, Glucose, Week 12, n=52, 55	0.36 (0.996)	0.30 (1.357)
INI, Glucose, Week 16, n=53, 52	0.35 (1.437)	0.13 (0.557)
INI, Glucose, Week 20, n=51, 57	0.25 (0.515)	-0.06 (0.676)
INI, Glucose, Week 24, n=59, 61	0.24 (0.596)	0.04 (0.652)
INI, Glucose, Week 28, n=52, 62	0.17 (0.681)	0.33 (0.763)
INI, Glucose, Week 32, n=53, 55	0.48 (1.071)	0.32 (0.876)
INI, Glucose, Week 36, n=53, 57	0.34 (0.642)	0.19 (1.063)
INI, Glucose, Week 40, n=59, 62	0.36 (0.922)	0.14 (0.566)
INI, Glucose, Week 44, n=54, 57	0.33 (0.971)	0.16 (0.626)
INI, Glucose, Week 48, n=81, 90	0.04 (0.577)	-0.03 (0.796)
NNRTI, Glucose, Week 4, n=116, 124	0.20 (0.666)	0.24 (1.055)
NNRTI, Glucose, Week 8, n=90, 116	0.27 (0.987)	0.23 (0.795)
NNRTI, Glucose, Week 12, n=112, 119	0.16 (0.746)	0.11 (0.887)
NNRTI, Glucose, Week 16, n=115, 116	0.22 (0.767)	0.33 (1.347)
NNRTI, Glucose, Week 20, n=106, 118	0.25 (0.636)	0.28 (1.104)
NNRTI, Glucose, Week 24, n=115, 121	0.27 (0.763)	0.16 (1.037)
NNRTI, Glucose, Week 28, n=104, 120	0.23 (0.596)	0.30 (1.077)
NNRTI, Glucose, Week 32, n=103, 117	0.32 (0.811)	0.24 (1.062)
NNRTI, Glucose, Week 36, n=102, 117	0.17 (0.789)	0.31 (1.217)
NNRTI, Glucose, Week 40, n=100, 111	0.27 (0.692)	0.33 (1.118)
NNRTI, Glucose, Week 44, n=99, 116	0.26 (0.793)	0.35 (1.121)
NNRTI, Glucose, Week 48, n=118, 136	0.06 (0.659)	0.02 (1.074)
PI, Phosphate, Week 4, n=51, 53	0.068 (0.1513)	0.009 (0.1682)
PI, Phosphate, Week 8, n=34, 53	0.076 (0.2023)	-0.019 (0.1752)
PI, Phosphate, Week 12, n=50, 52	0.025 (0.1794)	0.007 (0.1524)
PI, Phosphate, Week 16, n=48, 53	0.056 (0.2028)	-0.008 (0.1610)
PI, Phosphate, Week 20, n=46, 53	0.069 (0.1864)	0.017 (0.1924)
PI, Phosphate, Week 24, n=47, 53	0.037 (0.1971)	0.018 (0.1735)
PI, Phosphate, Week 28, n=42, 53	0.035 (0.2140)	0.017 (0.1971)
PI, Phosphate, Week 32, n=45, 51	0.053 (0.2191)	0.032 (0.1545)
PI, Phosphate, Week 36, n=44, 50	0.032 (0.1818)	-0.001 (0.1828)
PI, Phosphate, Week 40, n=42, 51	0.027 (0.2392)	0.001 (0.1657)
PI, Phosphate, Week 44, n=47, 51	0.033 (0.2107)	0.011 (0.1736)
PI, Phosphate, Week 48, n=43, 50	0.048 (0.1994)	0.017 (0.1387)
INI, Phosphate, Week 4, n=99, 97	0.036 (0.1518)	0.017 (0.1588)
INI, Phosphate, Week 8, n=73, 98	0.056 (0.1532)	0.010 (0.1676)
INI, Phosphate, Week 12, n=99, 95	0.024 (0.2108)	0.017 (0.1808)
INI, Phosphate, Week 16, n=93, 96	0.031 (0.1895)	0.001 (0.1708)
INI, Phosphate, Week 20, n=93, 97	0.012 (0.1764)	0.025 (0.1823)
INI, Phosphate, Week 24, n=94, 95	0.031 (0.1501)	-0.011 (0.1785)
INI, Phosphate, Week 28, n=89, 93	0.032 (0.1628)	0.006 (0.1806)
INI, Phosphate, Week 32, n=93, 95	0.012 (0.1751)	-0.017 (0.1827)
INI, Phosphate, Week 36, n=94, 95	-0.002 (0.1496)	-0.001 (0.1979)
INI, Phosphate, Week 40, n=90, 95	0.018 (0.1766)	-0.002 (0.1721)
INI, Phosphate, Week 44, n=91, 94	0.005 (0.1695)	0.005 (0.1977)
INI, Phosphate, Week 48, n=91, 95	0.028 (0.1684)	0.002 (0.2072)
NNRTI, Phosphate, Week 4, n=151, 153	0.085 (0.1785)	0.016 (0.1580)
NNRTI, Phosphate, Week 8, n=122, 152	0.061 (0.2002)	-0.012 (0.1515)
NNRTI, Phosphate, Week 12, n=146, 152	0.057 (0.1946)	0.012 (0.1780)
NNRTI, Phosphate, Week 16, n=143, 149	0.043 (0.2088)	0.008 (0.1613)
NNRTI, Phosphate, Week 20, n=138, 152	0.039 (0.1935)	-0.002 (0.1823)
NNRTI, Phosphate, Week 24, n=143, 151	0.050 (0.2220)	0.012 (0.1923)
NNRTI, Phosphate, Week 28, n=136, 150	0.040 (0.1850)	-0.003 (0.1789)
NNRTI, Phosphate, Week 32, n=137, 148	0.018 (0.2056)	0.011 (0.2020)
NNRTI, Phosphate, Week 36, n=135, 147	0.014 (0.2069)	-0.002 (0.1794)
NNRTI, Phosphate, Week 40, n=138, 147	0.026 (0.2095)	-0.006 (0.1783)
NNRTI, Phosphate, Week 44, n=137, 148	0.041 (0.2112)	0.000 (0.1735)
NNRTI, Phosphate, Week 48, n=131, 147	0.034 (0.2220)	-0.001 (0.1619)
PI, Potassium, Week 4, n=51, 53	0.12 (0.369)	0.20 (0.447)
PI, Potassium, Week 8, n=34, 53	0.05 (0.245)	0.08 (0.307)
PI, Potassium, Week 12, n=50, 52	0.12 (0.353)	0.19 (0.388)
PI, Potassium, Week 16, n=48, 53	0.02 (0.343)	0.19 (0.398)
PI, Potassium, Week 20, n=46, 53	0.05 (0.338)	0.18 (0.420)
PI, Potassium, Week 24, n=47, 53	0.01 (0.354)	0.19 (0.384)
PI, Potassium, Week 28, n=42, 53	0.09 (0.338)	0.15 (0.342)
PI, Potassium, Week 32, n=45, 51	0.02 (0.356)	0.19 (0.408)
PI, Potassium, Week 36, n=44, 50	0.12 (0.363)	0.14 (0.371)
PI, Potassium, Week 40, n=42, 51	0.09 (0.348)	0.15 (0.394)
PI, Potassium, Week 44, n=47, 51	0.10 (0.409)	0.21 (0.433)
PI, Potassium, Week 48, n=43, 50	0.02 (0.359)	0.01 (0.409)
INI, Potassium, Week 4, n=99, 97	0.03 (0.308)	0.08 (0.335)
INI, Potassium, Week 8, n=73, 98	-0.02 (0.282)	0.06 (0.483)
INI, Potassium, Week 12, n=99, 95	0.02 (0.316)	0.01 (0.329)
INI, Potassium, Week 16, n=93, 96	-0.01 (0.286)	0.01 (0.319)
INI, Potassium, Week 20, n=93, 97	0.03 (0.333)	0.00 (0.313)
INI, Potassium, Week 24, n=94, 95	0.02 (0.304)	0.04 (0.315)
INI, Potassium,Week 28, n=89, 93	0.02 (0.422)	0.03 (0.372)
INI, Potassium, Week 32, n=93, 95	0.02 (0.322)	0.01 (0.289)
INI, Potassium, Week 36, n=94, 95	0.01 (0.345)	0.05 (0.349)
INI, Potassium, Week 40, n=90, 95	0.01 (0.288)	0.01 (0.329)
INI, Potassium, Week 44, n=91, 94	0.01 (0.265)	0.00 (0.327)
INI, Potassium, Week 48, n=91, 95	-0.03 (0.249)	-0.01 (0.292)
NNRTI, Potassium, Week 4, n=151, 153	0.05 (0.354)	0.10 (0.368)
NNRTI, Potassium, Week 8, n=122, 152	0.02 (0.342)	0.05 (0.355)
NNRTI, Potassium, Week 12, n=146, 152	0.02 (0.351)	0.08 (0.353)
NNRTI, Potassium, Week 16, n=143, 149	0.03 (0.373)	0.05 (0.320)
NNRTI, Potassium,Week 20, n=138, 152	0.04 (0.358)	0.03 (0.355)
NNRTI, Potassium, Week 24, n=143, 150	0.04 (0.329)	0.04 (0.324)
NNRTI, Potassium, Week 28, n=136, 150	0.03 (0.364)	0.08 (0.412)
NNRTI, Potassium, Week 32, n=137, 148	0.01 (0.442)	0.02 (0.348)
NNRTI, Potassium, Week 36, n=135, 147	0.02 (0.359)	0.05 (0.360)
NNRTI, Potassium, Week 40, n=138, 147	0.05 (0.375)	0.08 (0.342)
NNRTI, Potassium, Week 44, n=137, 148	0.08 (0.364)	0.07 (0.366)
NNRTI, Potassium, Week 48, n=131, 147	-0.02 (0.311)	0.00 (0.329)
PI, Sodium, Week 4, n=51, 53	0.4 (1.93)	0.3 (2.11)
PI, Sodium, Week 8, n=34, 53	0.9 (2.21)	0.3 (2.25)
PI, Sodium, Week 12, n=50, 52	0.5 (2.09)	0.7 (1.97)
PI, Sodium, Week 16, n=48, 53	0.5 (2.30)	0.3 (2.24)
PI, Sodium, Week 20, n=46, 53	0.6 (2.15)	0.4 (2.12)
PI, Sodium, Week 24, n=47, 53	0.5 (2.33)	0.4 (2.30)
PI, Sodium, Week 28, n=42, 53	1.3 (2.06)	0.8 (2.75)
PI, Sodium, Week 32, n=45, 51	0.5 (2.47)	0.5 (2.26)
PI, Sodium, Week 36, n=44, 50	0.8 (2.21)	0.6 (2.63)
PI, Sodium, Week 40, n=42, 51	0.8 (2.20)	0.7 (2.03)
PI, Sodium, Week 44, n=47, 51	0.8 (2.10)	0.7 (2.49)
PI, Sodium, Week 48, n=43, 50	0.9 (1.98)	0.8 (1.95)
INI, Sodium, Week 4, n=99, 97	0.3 (1.62)	0.0 (1.97)
INI, Sodium, Week 8, n=73, 98	0.1 (1.98)	-0.3 (1.87)
INI, Sodium, Week 12, n=99, 95	0.3 (2.11)	0.0 (1.69)
INI, Sodium, Week 16, n=93, 96	0.3 (1.95)	0.4 (1.97)
INI, Sodium, Week 20, n=93, 97	0.5 (1.94)	0.1 (1.86)
INI, Sodium, Week 24, n=94, 95	0.5 (1.79)	0.0 (1.73)
INI, Sodium, Week 28, n=89, 93	0.5 (1.74)	-0.3 (1.93)
INI, Sodium, Week 32, n=93, 95	0.5 (1.87)	0.2 (1.75)
INI, Sodium, Week 36, n=94, 95	0.4 (1.86)	0.3 (1.88)
INI, Sodium, Week 40, n=90, 95	0.5 (1.91)	0.2 (2.01)
INI, Sodium, Week 44, n=91, 94	0.5 (1.77)	0.3 (1.93)
INI, Sodium, Week 48, n=91, 95	0.4 (2.00)	-0.1 (1.85)
NNRTI, Sodium, Week 4, n=151, 153	0.2 (1.95)	0.1 (1.98)
NNRTI, Sodium, Week 8, n=122, 152	0.2 (1.91)	0.0 (1.82)
NNRTI, Sodium, Week 12, n=146, 152	0.1 (2.04)	0.1 (2.01)
NNRTI, Sodium, Week 16, n=143, 149	-0.1 (2.28)	-0.2 (2.04)
NNRTI, Sodium, Week 20, n=138, 152	-0.1 (2.14)	0.3 (1.95)
NNRTI, Sodium, Week 24, n=143, 151	0.1 (2.14)	0.3 (1.95)
NNRTI, Sodium, Week 28, n=136, 150	0.3 (2.29)	0.2 (2.18)
NNRTI, Sodium, Week 32, n=137, 148	0.1 (2.01)	0.5 (1.84)
NNRTI, Sodium, Week 36, n=135, 147	0.4 (2.05)	0.5 (2.22)
NNRTI, Sodium, Week 40, n=138, 147	0.3 (2.04)	0.5 (2.12)
NNRTI, Sodium, Week 44, n=137, 148	0.5 (2.17)	0.5 (1.96)
NNRTI, Sodium, Week 48, n=131, 147	0.3 (2.39)	0.4 (1.97)
PI, Urea, Week 4, n=51, 53	0.02 (1.449)	0.01 (1.124)
PI, Urea, Week 8, n=34, 53	0.21 (1.142)	-0.02 (1.205)
PI, Urea, Week 12, n=50, 52	0.04 (1.446)	-0.01 (1.312)
PI, Urea, Week 16, n=48, 53	0.25 (1.309)	0.20 (1.377)
PI, Urea, Week 20, n=46, 53	0.18 (1.425)	0.17 (1.275)
PI, Urea, Week 24, n=47, 53	0.41 (1.248)	0.10 (1.182)
PI, Urea, Week 28, n=42, 53	0.18 (1.352)	0.00 (1.236)
PI, Urea, Week 32, n=45, 51	0.12 (1.567)	0.16 (1.210)
PI, Urea, Week 36, n=44, 50	0.01 (1.449)	-0.13 (1.190)
PI, Urea, Week 40, n=42, 51	0.17 (1.291)	0.33 (1.714)
PI, Urea, Week 44, n=47, 51	0.36 (1.258)	0.13 (1.276)
PI, Urea, Week 48, n=43, 50	0.10 (1.303)	0.13 (1.305)
INI, Urea, Week 4, n=99, 97	-0.14 (1.477)	0.19 (1.635)
INI, Urea, Week 8, n=73, 98	-0.14 (1.799)	0.01 (1.601)
INI, Urea, Week 12, n=99, 95	0.05 (1.554)	0.21 (1.481)
INI, Urea, Week 16, n=93, 96	0.01 (1.402)	0.05 (1.375)
INI, Urea, Week 20, n=93, 97	0.01 (1.531)	0.15 (1.495)
INI, Urea, Week 24, n=94, 95	0.04 (1.367)	0.12 (1.441)
INI, Urea, Week 28, n=89, 93	0.01 (1.570)	-0.02 (1.579)
INI, Urea, Week 32, n=93, 95	-0.09 (1.592)	0.01 (1.522)
INI, Urea, Week 36, n=94, 95	-0.10 (1.514)	-0.05 (1.478)
INI, Urea, Week 40, n=90, 95	0.01 (1.519)	0.12 (1.469)
INI, Urea, Week 44, n=91, 94	-0.16 (1.583)	-0.19 (1.721)
INI, Urea, Week 48, n=91, 95	0.11 (1.633)	-0.05 (1.304)
NNRTI, Urea, Week 4, n=151, 153	0.10 (1.265)	0.04 (1.185)
NNRTI, Urea, Week 8, n=122, 152	0.16 (1.286)	0.01 (1.252)
NNRTI, Urea, Week 12, n=146, 152	0.26 (1.290)	0.06 (1.344)
NNRTI, Urea, Week 16, n=143, 149	0.07 (1.407)	0.28 (1.609)
NNRTI, Urea, Week 20, n=138, 152	0.25 (1.296)	0.07 (1.507)
NNRTI, Urea, Week 24, n=143, 151	0.33 (1.499)	0.18 (1.276)
NNRTI, Urea, Week 28, n=136, 150	0.22 (1.549)	0.02 (1.422)
NNRTI, Urea, Week 32, n=137, 148	0.41 (1.410)	0.06 (1.416)
NNRTI, Urea, Week 36, n=135, 147	0.19 (1.339)	0.04 (1.392)
NNRTI, Urea, Week 40, n=138, 147	0.32 (1.347)	-0.01 (1.339)
NNRTI, Urea, Week 44, n=137, 148	0.25 (1.346)	0.10 (1.344)
NNRTI, Urea, Week 48, n=131, 147	0.37 (1.389)	-0.02 (1.325)

71. Secondary Outcome

Title	Change From Baseline Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48
Description	Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Week 48

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
PI, Triglycerides, Week 48, n=40, 45	-0.733 (1.5612)	0.060 (0.9960)
INI, Triglycerides, Week 48, n=72, 77	-0.078 (0.4964)	-0.117 (0.8052)
NNRTI, Triglycerides, Week 48, n=119, 120	-0.015 (0.6121)	-0.014 (0.6761)
PI, Cholesterol, Week 48, n=40, 45	-0.06 (0.629)	0.06 (0.744)
INI, Cholesterol, Week 48, n=72, 77	0.18 (0.614)	-0.12 (0.674)
NNRTI, Cholesterol, Week 48, n=119, 120	0.06 (0.743)	-0.02 (0.626)
PI, HDL cholesterol, Week 48, n=40, 45	0.130 (0.2272)	0.001 (0.3429)
INI, HDL cholesterol, Week 48, n=72, 77	0.074 (0.2339)	-0.038 (0.2308)
NNRTI, HDL cholesterol, Week 48, n=119, 120	-0.011 (0.2936)	0.028 (0.2577)
PI, LDL cholesterol, Week 48, n=37, 43	0.075 (0.5774)	0.043 (0.5545)
INI, LDL cholesterol, Week 48, n=71, 76	0.144 (0.4840)	-0.015 (0.5333)
NNRTI, LDL cholesterol, Week 48, n=116, 119	0.078 (0.6885)	-0.040 (0.5246)

72. Secondary Outcome

Title	Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48
Description	Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.
Time Frame	At the time of CVF

Outcome Measure Data

Analysis Population Description

CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	3	4
PI, INI, DTG, resistant, n=1, 0	0 0%	0 0%
PI, INI, DTG, resistance possible, n=1, 0	0 0%	0 0%
PI, INI, DTG, sensitive, n=1, 0	1 0.3%	0 0%
PI, INI, EVG, resistant, n=1, 0	0 0%	0 0%
PI, INI, EVG, resistance possible, n=1, 0	0 0%	0 0%
PI, INI, EVG, sensitive, n=1, 0	1 0.3%	0 0%
PI, INI, RAL, resistant, n=1, 0	0 0%	0 0%
PI, INI, RAL, resistance possible, n=1, 0	0 0%	0 0%
PI, INI, RAL, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, DLV, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, DLV, resistance possible, n=1, 0	0 0%	0 0%
PI, NNRTI, DLV, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, EFV, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, EFV, resistance possible, n=1, 0	0 0%	0 0%
PI, NNRTI, EFV, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, ETR, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, ETR, resistance possible, n=1, 0	0 0%	0 0%
PI, NNRTI, ETR, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, NVP, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, NVP, resistance possible, n=1, 0	0 0%	0 0%
PI, NNRTI, NVP, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, RPV, resistant, n=1, 0	1 0.3%	0 0%
PI, NNRTI, RPV, resistance possible, n=1, 0	0 0%	0 0%
PI, NNRTI, RPV, sensitive, n=1, 0	0 0%	0 0%
PI, NRTI, 3TC, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, 3TC, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, 3TC, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, ABC, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, ABC, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, ABC, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, FTC, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, FTC, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, FTC, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, TDF, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, TDF, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, TDF, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, ZDV, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, ZDV, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, ZDV, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, d4T, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, d4T, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, d4T, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, ddI, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, ddI, resistance possible, n=1, 0	0 0%	0 0%
PI, NRTI, ddI, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, ATV, resistant, n=1, 0	0 0%	0 0%
PI, PI, ATV, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, ATV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, ATV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, ATV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, ATV/r, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, DRV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, DRV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, DRV/r, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, FPV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, FPV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, FPV/r, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, IDV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, IDV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, IDV/r, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, LPV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, LPV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, LPV/r, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, NFV, resistant, n=1, 0	0 0%	0 0%
PI, PI, NFV, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, NFV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, RTV, resistant, n=1, 0	0 0%	0 0%
PI, PI, RTV, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, RTV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, SQV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, SQV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, SQV/r, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, TPV/r, resistant, n=1, 0	0 0%	0 0%
PI, PI, TPV/r, resistance possible, n=1, 0	0 0%	0 0%
PI, PI, TPV/r, sensitive, n=1, 0	1 0.3%	0 0%
INI, INI, DTG, resistant, n=0, 3	0 0%	0 0%
INI, INI, DTG, resistance possible, n=0, 3	0 0%	0 0%
INI, INI, DTG, sensitive, n=0, 3	0 0%	3 1%
INI, INI, EVG, resistant, n=0, 3	0 0%	0 0%
INI, INI, EVG, resistance possible, n=0, 3	0 0%	0 0%
INI, INI, EVG, sensitive, n=0, 3	0 0%	3 1%
INI, INI, RAL, resistant, n=0, 3	0 0%	0 0%
INI, INI, RAL, resistance possible, n=0, 3	0 0%	0 0%
INI, INI, RAL, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, DLV, resistant, n=0, 3	0 0%	0 0%
INI, INI, DLV, resistance possible, n=0, 3	0 0%	0 0%
INI, NNRTI, DLV, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, EFV, resistant, n=0, 3	0 0%	0 0%
INI, INI, EFV, resistance possible, n=0, 3	0 0%	0 0%
INI, NNRTI, EFV, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, ETR, resistant,, n=0, 3	0 0%	0 0%
INI, NNRTI, ETR, resistance possible, n=0, 3	0 0%	0 0%
INI, NNRTI, ETR, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, NVP, resistant, n=0, 3	0 0%	0 0%
INI, NNRTI, NVP, resistance possible, n=0, 3	0 0%	0 0%
INI, NNRTI, NVP, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, RPV, resistant, n=0, 3	0 0%	1 0.3%
INI, NNRTI, RPV, resistance possible, n=0, 3	0 0%	0 0%
INI, NNRTI, RPV, sensitive, n=0, 3	0 0%	2 0.6%
INI, NRTI, 3TC, resistant, n=0, 3	0 0%	1 0.3%
INI, NNRTI, 3TC, resistance possible, n=0, 3	0 0%	0 0%
INI, NRTI, 3TC, sensitive, n=0, 3	0 0%	2 0.6%
INI, NRTI, ABC, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, ABC, resistance possible,, n=0, 3	0 0%	0 0%
INI, NRTI, ABC, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, FTC, resistant, n=0, 3	0 0%	1 0.3%
INI, NRTI, FTC, resistance possible, n=0, 3	0 0%	0 0%
INI, NRTI, FTC, sensitive, n=0, 3	0 0%	2 0.6%
INI, NRTI, TDF, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, TDF, resistance possible, n=0, 3	0 0%	0 0%
INI, NRTI, TDF, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, ZDV, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, ZDV, resistance possible, n=0, 3	0 0%	0 0%
INI, NRTI, ZDV, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, d4T, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, d4T, resistance possible, n=0, 3	0 0%	0 0%
INI, NRTI, d4T, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, ddI, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, ddI, resistance possible, n=0, 3	0 0%	1 0.3%
INI, NRTI, ddI, sensitive, n=0, 3	0 0%	2 0.6%
INI, PI, ATV, resistant, n=0, 3	0 0%	0 0%
INI, PI, ATV, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, ATV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, ATV/r, n=0, 3	0 0%	0 0%
INI, PI, ATV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, ATV/r, sensitive, n=0, 3	0 0%	3 1%
INI, PI, DRV/r, resistant, n=0, 3	0 0%	0 0%
INI, PI, DRV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, DRV/r, sensitive, n=0, 3	0 0%	3 1%
INI, PI, FPV/r, resistant, n=0, 3	0 0%	0 0%
INI, PI, FPV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, FPV/r, sensitive, n=0, 3	0 0%	3 1%
INI, PI, IDV/r, resistant, n=0, 3	0 0%	0 0%
INI, PI, IDV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, IDV/r, sensitive, n=0, 3	0 0%	3 1%
INI, PI, LPV/r, resistant, n=0, 3	0 0%	0 0%
INI, PI, LPV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, LPV/r, sensitive, n=0, 3	0 0%	3 1%
INI, PI, NFV, resistant, n=0, 3	0 0%	0 0%
INI, PI, NFV, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, NFV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, RTV, resistant, n=0, 3	0 0%	0 0%
INI, PI, RTV, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, RTV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, SQV/r, resistant, n=0, 3	0 0%	0 0%
INI, PI, SQV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, SQV/r, sensitive, n=0, 3	0 0%	3 1%
INI, PI, TPV/r, resistant, n=0, 3	0 0%	0 0%
INI, PI, TPV/r, resistance possible, n=0, 3	0 0%	0 0%
INI, PI, TPV/r, sensitive, n=0, 3	0 0%	3 1%
NNRTI, INI, DTG, resistant, n=2, 1	0 0%	0 0%
NNRTI, INI, DTG, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, INI, DTG, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, INI, EVG, resistant, n=2, 1	1 0.3%	0 0%
NNRTI, INI, EVG, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, INI, EVG, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, INI, RAL, resistant, n=2, 1	1 0.3%	0 0%
NNRTI, INI, RAL, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, INI, RAL, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, NNRTI, DLV, resistant, n=2, 1	0 0%	0 0%
NNRTI, INI, DLV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NNRTI, DLV, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, NNRTI, EFV, resistant, n=2, 1	1 0.3%	1 0.3%
NNRTI, INI, EFV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NNRTI, EFV, sensitive, n=2, 1	1 0.3%	0 0%
NNRTI, NNRTI, ETR, resistant, n=2, 1	0 0%	0 0%
NNRTI, NNRTI, ETR, resistance possible,n=2, 1	2 0.6%	0 0%
NNRTI, NNRTI, ETR, sensitive, n=2, 1	0 0%	1 0.3%
NNRTI, NNRTI, NVP, resistant, n=2, 1	1 0.3%	1 0.3%
NNRTI, NNRTI, NVP, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NNRTI, NVP, sensitive, n=2, 1	1 0.3%	0 0%
NNRTI, NNRTI, RPV, resistant, n=2, 1	2 0.6%	0 0%
NNRTI, NNRTI, RPV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NNRTI, RPV, sensitive, n=2, 1	0 0%	1 0.3%
NNRTI, NRTI, 3TC, resistant, n=2, 1	0 0%	1 0.3%
NNRTI, NNRTI, 3TC, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NRTI, 3TC, sensitive, n=2, 1	2 0.6%	0 0%
NNRTI, NRTI, ABC, resistant, n=2, 1	0 0%	0 0%
NNRTI, NRTI, ABC, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NRTI, ABC, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, NRTI, FTC, resistant, n=2, 1	0 0%	1 0.3%
NNRTI, NRTI, FTC, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NRTI, FTC, sensitive, n=2, 1	2 0.6%	0 0%
NNRTI, NRTI, TDF, resistant, n=2, 1	0 0%	0 0%
NNRTI, NRTI, TDF, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NRTI, TDF, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, NRTI, ZDV, resistant, n=2, 1	0 0%	0 0%
NNRTI, NRTI, ZDV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NRTI, ZDV, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, NRTI, d4T, resistant, n=2, 1	0 0%	0 0%
NNRTI, NRTI, d4T, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, NRTI, d4T, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, NRTI, ddI, resistant, n=2, 1	0 0%	0 0%
NNRTI, NRTI, ddI, resistance possible, n=2, 1	0 0%	1 0.3%
NNRTI, NRTI, ddI, sensitive, n=2, 1	2 0.6%	0 0%
NNRTI, PI, ATV, resistant, n=2, 1	1 0.3%	0 0%
NNRTI, PI, ATV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, ATV, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, PI, ATV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, ATV/r, resistance possible, n=2, 1	1 0.3%	0 0%
NNRTI, PI, ATV/r, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, PI, DRV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, DRV/r, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, DRV/r, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, PI, FPV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, FPV/r, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, FPV/r, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, PI, IDV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, IDV/r, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, IDV/r, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, PI, LPV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, LPV/r, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, LPV/r, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, PI, NFV, resistant, n=2, 1	1 0.3%	0 0%
NNRTI, PI, NFV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, NFV, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, PI, RTV, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, RTV, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, RTV, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, PI, SQV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, SQV/r, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, SQV/r, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, PI, TPV/r, resistant, n=2, 1	0 0%	0 0%
NNRTI, PI, TPV/r, resistance possible, n=2, 1	0 0%	0 0%
NNRTI, PI, TPV/r, sensitive, n=2, 1	2 0.6%	1 0.3%

73. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48
Description	Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Phenotypic Resistance data for the following drugs: CAB, DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. Phenotypic resistance, partially sensitive, and Sensitive were defined based on FC value from Monogram as: resistance (FC>clinical higher cutoff/biologic cutoff), partially sensitive (FC <=clinical higher cutoff and > clinical lower cutoff), sensitive (FC <= clinical lower cutoff/biologic cutoff).
Time Frame	At the time of CVF

Outcome Measure Data

Analysis Population Description

CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	3	4
PI, INI, CAB, resistant , n=1, 0	0 0%	0 0%
PI, INI, CAB, sensitive, n=1, 0	1 0.3%	0 0%
PI, INI, DTG, resistant, n=1, 0	0 0%	0 0%
PI, INI, DTG, partially sensitive, n=1, 0	0 0%	0 0%
PI, INI, DTG, sensitive, n=1, 0	1 0.3%	0 0%
PI, INI, EVG, resistant, n=1, 0	0 0%	0 0%
PI, INI, EVG, sensitive, n=1, 0	1 0.3%	0 0%
PI, INI, RAL, resistant, n=1, 0	0 0%	0 0%
PI, INI, RAL, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, DLV, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, DLV, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, EFV, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, EFV, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, ETR, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, ETR, partially sensitive, n=1, 0	0 0%	0 0%
PI, NNRTI, ETR, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, NVP, resistant, n=1, 0	0 0%	0 0%
PI, NNRTI, NVP, sensitive, n=1, 0	1 0.3%	0 0%
PI, NNRTI, RPV, resistant, n=1, 0	1 0.3%	0 0%
PI, NNRTI, RPV, sensitive, n=1, 0	0 0%	0 0%
PI, NRTI, 3TC, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, 3TC, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, ABC, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, ABC, partially sensitive, n=1, 0	0 0%	0 0%
PI, NRTI, ABC, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, FTC, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, FTC, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, TDF, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, TDF, partially sensitive, n=1, 0	0 0%	0 0%
PI, NRTI, TDF, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, ZDV, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, ZDV, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, d4T, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, d4T, sensitive, n=1, 0	1 0.3%	0 0%
PI, NRTI, ddI, resistant, n=1, 0	0 0%	0 0%
PI, NRTI, ddI, partially sensitive, n=1, 0	0 0%	0 0%
PI, NRTI, ddI, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, ATV, resistant, n=1, 0	0 0%	0 0%
PI, PI, ATV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, DRV, resistant, n=1, 0	0 0%	0 0%
PI, PI, DRV, partially sensitive, n=1, 0	0 0%	0 0%
PI, PI, DRV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, FPV, resistant, n=1, 0	0 0%	0 0%
PI, PI, FPV, partially sensitive, n=1, 0	0 0%	0 0%
PI, PI, FPV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, IDV, resistant, n=1, 0	0 0%	0 0%
PI, PI, IDV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, LPV, resistant, n=1, 0	0 0%	0 0%
PI, PI, LPV, partially sensitive, n=1, 0	0 0%	0 0%
PI, PI, LPV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, NFV, resistant, n=1, 0	0 0%	0 0%
PI, PI, NFV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, RTV, resistant, n=1, 0	0 0%	0 0%
PI, PI, RTV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, SQV, resistant, n=1, 0	0 0%	0 0%
PI, PI, SQV, partially sensitive, n=1, 0	0 0%	0 0%
PI, PI, SQV, sensitive, n=1, 0	1 0.3%	0 0%
PI, PI, TPV, resistant, n=1, 0	0 0%	0 0%
PI, PI, TPV, partially sensitive, n=1, 0	0 0%	0 0%
PI, PI, TPV, sensitive, n=1, 0	1 0.3%	0 0%
INI, INI, CAB, resistant , n=0, 3	0 0%	0 0%
INI, INI, CAB, sensitive, n=0, 3	0 0%	3 1%
INI, INI, DTG, resistant, n=0, 3	0 0%	0 0%
INI, INI, DTG, partially sensitive, n=0, 3	0 0%	0 0%
INI, INI, DTG, sensitive, n=0, 3	0 0%	3 1%
INI, INI, EVG, resistant, n=0, 3	0 0%	0 0%
INI, INI, EVG, sensitive, n=0, 3	0 0%	3 1%
INI, INI, RAL, resistant, n=0, 3	0 0%	0 0%
INI, INI, RAL, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, DLV, resistant, n=0, 3	0 0%	0 0%
INI, NNRTI, DLV, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, EFV, resistant, n=0, 3	0 0%	0 0%
INI, NNRTI, EFV, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, ETR, resistant, n=0, 3	0 0%	0 0%
INI, NNRTI, ETR, partially sensitive, n=0, 3	0 0%	0 0%
INI, NNRTI, ETR, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, NVP, resistant, n=0, 3	0 0%	0 0%
INI, NNRTI, NVP, sensitive, n=0, 3	0 0%	3 1%
INI, NNRTI, RPV, resistant, n=0, 3	0 0%	0 0%
INI, NNRTI, RPV, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, 3TC, resistant, n=0, 3	0 0%	1 0.3%
INI, NRTI, 3TC, sensitive, n=0, 3	0 0%	2 0.6%
INI, NRTI, ABC, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, ABC, partially sensitive, n=0, 3	0 0%	0 0%
INI, NRTI, ABC, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, FTC, resistant, n=0, 3	0 0%	1 0.3%
INI, NRTI, FTC, sensitive, n=0, 3	0 0%	2 0.6%
INI, NRTI, TDF, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, TDF, partially sensitive, n=0, 3	0 0%	0 0%
INI, NRTI, TDF, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, ZDV, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, ZDV, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, d4T, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, d4T, sensitive, n=0, 3	0 0%	3 1%
INI, NRTI, ddI, resistant, n=0, 3	0 0%	0 0%
INI, NRTI, ddI, partially sensitive, n=0, 3	0 0%	0 0%
INI, NRTI, ddI, sensitive, n=0, 3	0 0%	3 1%
INI, PI, ATV, resistant, n=0, 3	0 0%	0 0%
INI, PI, ATV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, DRV, resistant, n=0, 3	0 0%	0 0%
INI, PI, DRV, partially sensitive, n=0, 3	0 0%	0 0%
INI, PI, DRV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, FPV, resistant, n=0, 3	0 0%	0 0%
INI, PI, FPV, partially sensitive, n=0, 3	0 0%	0 0%
INI, PI, FPV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, IDV, resistant, n=0, 3	0 0%	0 0%
INI, PI, IDV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, LPV, resistant, n=0, 3	0 0%	0 0%
INI, PI, LPV, partially sensitive, n=0, 3	0 0%	0 0%
INI, PI, LPV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, NFV, resistant, n=0, 3	0 0%	0 0%
INI, PI, NFV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, RTV, resistant, n=0, 3	0 0%	0 0%
INI, PI, RTV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, SQV, resistant, n=0, 3	0 0%	0 0%
INI, PI, SQV, partially sensitive, n=0, 3	0 0%	0 0%
INI, PI, SQV, sensitive, n=0, 3	0 0%	3 1%
INI, PI, TPV, resistant, n=0, 3	0 0%	0 0%
INI, PI, TPV, partially sensitive, n=0, 3	0 0%	0 0%
INI, PI, TPV, sensitive, n=0, 3	0 0%	3 1%
NNRTI, INI, CAB, resistant , n=2, 1	1 0.3%	0 0%
NNRTI, INI, CAB, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, INI, DTG, resistant, n=2, 1	0 0%	0 0%
NNRTI, INI, DTG, partially sensitive, n=2, 1	0 0%	0 0%
NNRTI, INI, DTG, sensitive, n=2, 1	2 0.6%	1 0.3%
NNRTI, INI, EVG, resistant, n=2, 1	1 0.3%	0 0%
NNRTI, INI, EVG, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, INI, RAL, resistant, n=2, 1	1 0.3%	0 0%
NNRTI, INI, RAL, sensitive, n=2, 1	1 0.3%	1 0.3%
NNRTI, NNRTI, DLV, resistant, n=2, 0	2 0.6%	0 0%
NNRTI, NNRTI, DLV, sensitive, n=2, 0	0 0%	0 0%
NNRTI, NNRTI, EFV, resistant, n=2, 0	2 0.6%	0 0%
NNRTI, NNRTI, EFV, sensitive, n=2, 0	0 0%	0 0%
NNRTI, NNRTI, ETR, resistant, n=2, 0	0 0%	0 0%
NNRTI, NNRTI, ETR, partially sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, NNRTI, ETR, sensitive, n=2, 0	0 0%	0 0%
NNRTI, NNRTI, NVP, resistant, n=2, 0	2 0.6%	0 0%
NNRTI, NNRTI, NVP, sensitive, n=2, 0	0 0%	0 0%
NNRTI, NNRTI, RPV, resistant, n=2, 0	2 0.6%	0 0%
NNRTI, NNRTI, RPV, sensitive, n=2, 0	0 0%	0 0%
NNRTI, NRTI, 3TC, resistant, n=2, 0	0 0%	0 0%
NNRTI, NRTI, 3TC, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, NRTI, ABC, resistant, n=2, 0	0 0%	0 0%
NNRTI, NRTI, ABC, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, NRTI, ABC, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, NRTI, FTC, resistant, n=2, 0	0 0%	0 0%
NNRTI, NRTI, FTC, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, NRTI, TDF, resistant, n=2, 0	0 0%	0 0%
NNRTI, NRTI, TDF, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, NRTI, TDF, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, NRTI, ZDV, resistant, n=2, 0	1 0.3%	0 0%
NNRTI, NRTI, ZDV, sensitive, n=2, 0	1 0.3%	0 0%
NNRTI, NRTI, d4T, resistant, n=2, 0	0 0%	0 0%
NNRTI, NRTI, d4T, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, NRTI, ddI, resistant, n=2, 0	0 0%	0 0%
NNRTI, NRTI, ddI, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, NRTI, ddI, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, ATV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, ATV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, DRV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, DRV, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, PI, DRV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, FPV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, FPV, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, PI, FPV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, IDV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, IDV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, LPV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, LPV, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, PI, LPV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, NFV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, NFV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, RTV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, RTV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, SQV, resistant, n=2,0	0 0%	0 0%
NNRTI, PI, SQV, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, PI, SQV, sensitive, n=2, 0	2 0.6%	0 0%
NNRTI, PI, TPV, resistant, n=2, 0	0 0%	0 0%
NNRTI, PI, TPV, partially sensitive, n=2, 0	0 0%	0 0%
NNRTI, PI, TPV, sensitive, n=2, 0	2 0.6%	0 0%

74. Secondary Outcome

Title	Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm
Description	The PIN questionnaire explores the bother of pain at the injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCFwas used as primary method of analysis
Time Frame	Week 5 and at Weeks 41 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
Measure Participants	296
Bother of ISRs, Week 41	-0.21 (0.532)
Bother of ISRs, Week 48	-0.21 (0.524)
Leg movement, Week 41	-0.52 (0.903)
Leg movement, Week 48	-0.59 (0.950)
Sleep, Week 41	-0.56 (0.877)
Sleep, Week 48	-0.56 (0.937)
Acceptance, Week 41	-0.49 (1.094)
Acceptance, Week 48	-0.54 (1.080)

75. Secondary Outcome

Title	Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm
Description	The PIN questionnaire explores the bother of pain at the injection site and injection site reactions(ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCF was used as primary method of analysis
Time Frame	Weeks 5, 41 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
Measure Participants	308
Local reaction, Week 5, total, n=296	141 45.8%
Local reaction,Week 5, very acceptable, n=296	77 25%
Local reaction, Week 5, moderate, n=296	54 17.5%
Local reaction, Week 5, little, n=296	15 4.9%
Local reaction, Week 5, not at all, n=296	9 2.9%
Pain, Week 5, total, n=296	86 27.9%
Pain, Week 5, very acceptable, n=296	103 33.4%
Pain, Week 5, moderate, n=296	59 19.2%
Pain, Week 5, little, n=296	29 9.4%
Pain, Week 5, not at all, n=296	19 6.2%
Local reaction, Week 41, total, n=300	188 61%
Local reaction, Week 41, very acceptable, n=300	77 25%
Local reaction, Week 41, moderate, n=300	24 7.8%
Local reaction, Week 41, little, n=300	6 1.9%
Local reaction, Week 41, not at all, n=300	5 1.6%
Pain, Week 41, total, n=300	166 53.9%
Pain, Week 41, very acceptable, n=300	85 27.6%
Pain, Week 41, moderate, n=300	31 10.1%
Pain, Week 41, little, n=300	12 3.9%
Pain, Week 41, not at all, n=300	6 1.9%
Local reaction, week 48, total, n=303	202 65.6%
Local reaction, Week 48, very acceptable, n=303	69 22.4%
Local reaction, Week 48, moderate, n=303	21 6.8%
Local reaction, Week 48, little, n=303	8 2.6%
Local reaction, Week 48, not at all, n=303	3 1%
Pain, Week 48, total, n=303	168 54.5%
Pain, Week 48, very acceptable, n=303	95 30.8%
Pain, Week 48, moderate, n=303	26 8.4%
Pain, Week 48, little, n=303	11 3.6%
Pain, Week 48, not at all, n=303	3 1%

76. Secondary Outcome

Title	Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire
Description	The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% confidence interval (CI).Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 24, n=292, 291	1.0	1.1
Week 48, n=292, 297	1.1	0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.944
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -2.4 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.385
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.3 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

77. Secondary Outcome

Title	Change From Baseline in HIV Medication, MEDWO Using HATQoL
Description	The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=[100 divided by (20 minus 5)]*(MEDWO minus 5). A response of 1 in MEDWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 24, n=292, 290	4.2	-0.7
Week 48, n=292, 296	4.0	-2.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	4.9
	Confidence Interval	(2-Sided) 95%; 2.8 to 7.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	6.4
	Confidence Interval	(2-Sided) 95%; 4.0 to 8.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

78. Secondary Outcome

Title	Change From Baseline in DISWO Using HATQoL
Description	The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (20 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 24, n=291, 290	8.3	3.0
Week 48, n=291, 296	4.6	2.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	5.3
	Confidence Interval	(2-Sided) 95%; 1.4 to 9.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.347
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -2.2 to 6.2
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

79. Secondary Outcome

Title	Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12)
Description	The SF-12 questionnaire consists of 7 questions which measures the degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. The HRQoL using SF-12 for the total score, physical component summary (PCS) and the mental component summary (MCS) were assessed for the two treatment groups. Missing Total or the component scores was imputed using LOCF. The PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com). The higher the score, the better will be the health status. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Total score, Week 24, n=291, 289	0.0	-0.2
Total score, Week 48, n=293, 296	-0.0	0.0
MCS, Week 24, n=289, 286	0.288	-0.388
MCS, Week 48, n=291, 293	0.260	-0.375
PCS, Week 24, n=286, 288	0.650	-0.047
PCS, Week 48, n=288, 295	0.758	0.062

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.344
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.785
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.282
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.676
	Confidence Interval	(2-Sided) 95%; -0.557 to 1.909
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.327
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.635
	Confidence Interval	(2-Sided) 95%; -0.637 to 1.907
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.086
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.697
	Confidence Interval	(2-Sided) 95%; -0.100 to 1.494
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.092
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.696
	Confidence Interval	(2-Sided) 95%; -0.113 to 1.505
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

80. Secondary Outcome

Title	Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44
Description	The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants
Time Frame	Baseline and at Weeks 4b, 24 and 44

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 4b, n=295, 0	3.99 (8.982)
Week 24, n=300, 288	6.39 (10.328)	1.08 (8.510)
Week 44, n=300, 294	6.02 (10.808)	0.54 (9.877)

81. Secondary Outcome

Title	Change in Treatment Satisfaction Over Time Using HIVTSQ Change (HIVTSQc) at Week 48 in Q4W Arm
Description	The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA+RPV LA (Q4W)
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
Measure Participants	275
Mean (Standard Deviation) [Scores on a scale]	29.05 (6.978)

82. Secondary Outcome

Title	Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire
Description	The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication will be analyzed.Items on the scale are rated as 1-5 scores:1:totally disagree,2:somewhat disagree,3:somewhat agree, 4:totally agree and 5:I don't know.Total score of the dimension is calculated as the mean of the recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:score:Total Score=(mean of the recoded items in the dimension minus1)divided by2*100.LOCF was used as primary method of analysis.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI.Baseline value is defined as the latest pre-treatment assessment with a non-missing value.Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value
Time Frame	Baseline and at Weeks 8, 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Week 8, n=302, 287	8.9	1.0
Week 24, 303, 295	12.3	5.5
Week 48, n=302, 298	13.7	3.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	7.9
	Confidence Interval	(2-Sided) 95%; 4.1 to 11.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	6.9
	Confidence Interval	(2-Sided) 95%; 3.3 to 10.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	10.7
	Confidence Interval	(2-Sided) 95%; 7.1 to 14.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.

83. Secondary Outcome

Title	Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm
Description	The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.
Time Frame	Weeks 4b, 5, 40 and 41

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	CAB LA+RPV LA (Q4W)
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
Measure Participants	278
Week 5	2.0 (2.94)
Week 40	0.5 (2.79)
Week 41	0.4 (2.83)

84. Secondary Outcome

Title	Change From Baseline in Individual Item Scores of HIVTSQc at Weeks 4b, 24 and 44
Description	HIVTSQc is a 12 item questionnaire. The individual treatment change item scores on HIVTSQc scale are rated as +3 ('much more satisfied', 'much more convenient', 'much more flexible',etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). The higher the score, the greater the improvement in satisfaction with each aspect of treatment and the lower the score, the greater the deterioration in satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline and Weeks 4b, 24 and 44

Outcome Measure Data

Analysis Population Description

ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Measure Participants	308	308
Item 1; Week 4b; n=294, 0	0.3 (1.42)
Item 1; Week 24; n=300, 287	0.4 (1.46)	-0.1 (1.04)
Item 1; Week 44; n=300, 293	0.5 (1.42)	-0.1 (1.21)
Item 2; Week 4b; n=295, 0	0.0 (0.60)
Item 2; Week 24; n=300, 287	0.1 (0.70)	0.0 (0.68)
Item 2; Week 44; n=300, 293	0.1 (0.84)	-0.1 (0.82)
Item 3; Week 4b; n=295, 0	0.4 (1.35)
Item 3; Week 24; n=300, 288	0.3 (1.47)	0.1 (1.12)
Item 3; Week 44; n=300, 294	0.3 (1.45)	0.0 (1.26)
Item 4; Week 4b; n=295, 0	0.3 (1.21)
Item 4; Week 24; n=300, 288	0.5 (1.29)	-0.0 (1.16)
Item 4; Week 44; n=300, 294	0.4 (1.30)	-0.1 (1.22)
Item 5; Week 4b; n=295, 0	0.5 (1.24)
Item 5; Week 24; n=300, 288	0.8 (1.32)	0.1 (1.31)
Item 5; Week 44; n=300, 294	0.8 (1.42)	0.0 (1.37)
Item 6; Week 4b; n=294, 0	0.5 (1.63)
Item 6; Week 24; n=299, 288	0.8 (1.77)	0.2 (1.79)
Item 6; Week 44; n=299, 293	0.9 (1.72)	0.2 (1.78)
Item 7; Week 4b; n=295, 0	0.2 (0.90)
Item 7; Week 24; n=300, 288	0.2 (0.94)	0.1 (1.00)
Item 7; Week 44; n=300, 294	0.2 (0.99)	0.2 (1.08)
Item 8; Week 4b; n=294, 0	0.3 (1.21)
Item 8; Week 24; n=299, 288	0.7 (1.27)	0.1 (1.20)
Item 8; Week 44; n=299, 294	0.6 (1.31)	0.0 (1.27)
Item 9; Week 4b; n=294, 0	0.4 (1.22)
Item 9; Week 24; n=299, 288	0.6 (1.27)	0.1 (1.20)
Item 9; Week 44; n=299, 294	0.5 (1.32)	0.0 (1.25)
Item 10; Week 4b; n=293, 0	0.8 (1.44)
Item 10; Week 24; n=298, 287	1.2 (1.56)	0.3 (1.38)
Item 10; Week 44; n=298, 293	1.1 (1.64)	0.2 (1.60)
Item 11; Week 4b; n=292, 0	0.4 (1.23)
Item 11; Week 24; n=297, 287	0.7 (1.31)	0.1 (1.28)
Item 11; Week 44; n=297, 293	0.6 (1.45)	0.1 (1.38)
Item 12; Week 4b; n=293, 0	0.3 (1.41)
Item 12; Week 24; n=298, 287	0.0 (1.52)	0.1 (1.14)
Item 12; Week 44; n=298, 293	0.0 (1.58)	0.2 (1.17)

85. Other Pre-specified Outcome

Title	Number of Participants With Different Demographic Parameters for Inter-subject Variability
Description	Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters.
Time Frame	Upto Week 48

Outcome Measure Data

Analysis Population Description

PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.

Arm/Group Title	CAB LA	RPV LA
Arm/Group Description	Participants received IM injections of CAB LA 400 mg every four weeks through Week 52.	Participants received IM injections of RPV LA 900 mg every four weeks through Week 52.
Measure Participants	0	0

Adverse Events

Time Frame	Up to Week 52
Adverse Event Reporting Description	AEs and SAEs were collected in Safety population.
Arm/Group Title	CAB LA+RPV LA (Q4W)		Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period		During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
All Cause Mortality
	CAB LA+RPV LA (Q4W)		Current ART
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/308 (0%)		1/308 (0.3%)
Serious Adverse Events
	CAB LA+RPV LA (Q4W)		Current ART
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/308 (4.2%)		14/308 (4.5%)
Gastrointestinal disorders
Colitis	0/308 (0%)	0	2/308 (0.6%)	3
Pancreatitis acute	1/308 (0.3%)	1	0/308 (0%)	0
Vomiting	1/308 (0.3%)	1	0/308 (0%)	0
General disorders
Chest discomfort	0/308 (0%)	0	1/308 (0.3%)	1
Hepatobiliary disorders
Cholecystitis acute	1/308 (0.3%)	1	0/308 (0%)	0
Hepatocellular injury	1/308 (0.3%)	1	0/308 (0%)	0
Hyperbilirubinaemia	1/308 (0.3%)	1	0/308 (0%)	0
Infections and infestations
Hepatitis A	1/308 (0.3%)	1	1/308 (0.3%)	1
Acute hepatitis B	1/308 (0.3%)	1	0/308 (0%)	0
Anal abscess	0/308 (0%)	0	1/308 (0.3%)	1
Appendicitis	0/308 (0%)	0	1/308 (0.3%)	1
Gastroenteritis Escherichia coli	1/308 (0.3%)	1	0/308 (0%)	0
Liver abscess	1/308 (0.3%)	1	0/308 (0%)	0
Pneumonia	0/308 (0%)	0	1/308 (0.3%)	1
Pyelonephritis acute	1/308 (0.3%)	1	0/308 (0%)	0
Viral infection	1/308 (0.3%)	1	0/308 (0%)	0
Injury, poisoning and procedural complications
Animal bite	0/308 (0%)	0	1/308 (0.3%)	1
Eye injury	0/308 (0%)	0	1/308 (0.3%)	1
Overdose	0/308 (0%)	0	1/308 (0.3%)	1
Skull fracture	0/308 (0%)	0	1/308 (0.3%)	1
Investigations
Liver function test abnormal	1/308 (0.3%)	1	0/308 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/308 (0.3%)	1	0/308 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	0/308 (0%)	0	1/308 (0.3%)	1
Papillary thyroid cancer	1/308 (0.3%)	1	0/308 (0%)	0
Seminoma	0/308 (0%)	0	1/308 (0.3%)	1
Nervous system disorders
Cerebrovascular accident	0/308 (0%)	0	1/308 (0.3%)	1
Pregnancy, puerperium and perinatal conditions
Abortion missed	1/308 (0.3%)	1	0/308 (0%)	0
Abortion spontaneous	0/308 (0%)	0	1/308 (0.3%)	1
Psychiatric disorders
Suicidal ideation	0/308 (0%)	0	1/308 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory distress	0/308 (0%)	0	1/308 (0.3%)	1
Other (Not Including Serious) Adverse Events
	CAB LA+RPV LA (Q4W)		Current ART
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	263/308 (85.4%)		117/308 (38%)
Gastrointestinal disorders
Diarrhoea	22/308 (7.1%)	24	15/308 (4.9%)	17
General disorders
Injection site pain	231/308 (75%)	1208	0/308 (0%)	0
Injection site nodule	37/308 (12%)	54	0/308 (0%)	0
Injection site induration	30/308 (9.7%)	54	0/308 (0%)	0
Pyrexia	21/308 (6.8%)	29	9/308 (2.9%)	9
Fatigue	22/308 (7.1%)	29	6/308 (1.9%)	9
Injection site swelling	23/308 (7.5%)	48	0/308 (0%)	0
Infections and infestations
Nasopharyngitis	52/308 (16.9%)	87	42/308 (13.6%)	58
Upper respiratory tract infection	32/308 (10.4%)	48	25/308 (8.1%)	30
Influenza	17/308 (5.5%)	19	14/308 (4.5%)	15
Respiratory tract infection viral	11/308 (3.6%)	12	17/308 (5.5%)	23
Musculoskeletal and connective tissue disorders
Back pain	20/308 (6.5%)	22	10/308 (3.2%)	12
Nervous system disorders
Headache	34/308 (11%)	48	17/308 (5.5%)	19
Respiratory, thoracic and mediastinal disorders
Cough	16/308 (5.2%)	20	14/308 (4.5%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.