A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02120352
• Collaborator: Janssen Pharmaceuticals (Industry), GlaxoSmithKline (Industry)
• Enrollment: 309
• Locations: 50
• Arms: 3
• Anticipated Duration (Months): 104.1
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278.

The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.

The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus; HIV Infections	Drug: GSK744; Drug: GSK744 LA; Drug: TMC278 LA; Drug: ABC/3TC; Drug: RPV	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 309 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 Plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of GSK1265744 Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects
• Actual Study Start Date: Apr 28, 2014
• Actual Primary Completion Date: Aug 13, 2015
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks (Q8W) In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subject will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subject will receive following IM doses: Day 1 only - GSK744 LA 800 mg (loading dose delivered as two 400 mg IM injections) + TMC278 LA 900 mg IM. Week 4 only - GSK744 LA 600 mg IM (second loading dose, no TMC278).Week 8 - GSK744 LA 600 mg IM + TMC278 LA 900 mg IM every 8 weeks for 96 weeks.	Drug: GSK744 LA; Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection; Drug: TMC278 LA; Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.; Drug: ABC/3TC; ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC; Drug: RPV; Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
Experimental: GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks (Q4W) In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subjects will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subjects will receive following IM doses: Day 1 only - GSK744 LA 800 mg (loading dose delivered as two 400 mg IM injections) + TMC278 LA 600 mg IM. Week 4 - GSK744 LA 400 mg IM + TMC278 LA 600 mg IM every 4 weeks for 96 weeks	Drug: GSK744 LA; Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection; Drug: TMC278 LA; Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.; Drug: ABC/3TC; ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC; Drug: RPV; Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
Active Comparator: Oral Control Arm In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subjects will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subjects will receive an oral regimen of 30 mg of GSK744 and ABC/3TC once daily for 96 weeks (or 104 weeks if going on to the Extension Period)	Drug: GSK744; White to almost white oval shaped film coated 30 mg tablets for oral administration.; Drug: ABC/3TC; ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC; Drug: RPV; Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 [Week 32]

   Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).

2. Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 [Up to Week 32]

   Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.

3. Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) [Up to 20 weeks]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.

4. Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) [Up to an average of 59 weeks]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.

5. Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade [Up to an average of 59 weeks]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.

6. Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters [Up to an average of 59 weeks]

   Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.

7. Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters [Up to an average of 59 weeks]

   Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.

8. Number of Participants With Post-Baseline Urinalysis Dipstick Results [Up to an average of 59 weeks]

   Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.

Secondary Outcome Measures

1. Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Week -20, Week -16, Week -12, Week -8, Week -4, Day 1]

   Percentage of participants with HIV-1 RNA <200 c/mL and <50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product.

2. Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Week -20, Week -16, Week -12, Week -8, Week -4, Day 1]

   Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented.

3. Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

   Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.

4. Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Week -20, Week -16, Week -12, Week -4, Day 1]

   Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented.

5. Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1]

   Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

6. Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Up to 20 Weeks]

   An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

7. Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Up to Week 20]

   Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.

8. Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) [Up to 20 weeks]

   Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.

9. Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

   Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

10. Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

11. Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

12. Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

13. Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

14. Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

15. Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

16. Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

17. Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

18. Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) [Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1]

    Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

19. Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 32 (Maintenance Period) [Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32]

    Percentage of participants with HIV-1 RNA <50 c/mL and <200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders.

20. Number of Participants With Protocol Defined Virologic Failure at Week 32 (Maintenance Period) [Week 32]

    Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.

21. Absolute Value of Plasma HIV-1 RNA at Week 32 (Maintenance Period) [Week 32]

    Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented.

22. Change From Baseline in Plasma HIV-1 RNA at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.

23. Absolute Value of CD4+ at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.

24. Change From Baseline in CD4+ at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value.

25. Number of Participants With HIV-1 Disease Progression Over Week 32 (Maintenance Period) [Up to Week 32]

    HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.

26. Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) [Up to Week 32]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

27. Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

28. Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

29. Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

30. Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

31. Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

32. Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

33. Change From Baseline in Hematology Parameter: Hematocrit at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

34. Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

35. Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

36. Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 (Maintenance Period) [Baseline (Week -20) and Week 32]

    Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

37. Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) [pre-dose and 2 hours post dose on Day 1, pre-dose on Weeks 1,4,8,12,16,20,24,25,28 and 32]

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data.

38. Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) [pre-dose and 2 hours post dose on Day 1, pre-dose on Weeks 1,4,8,12,16,20,24,25,28 and 32]

    Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated.

39. Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) [Pre-dose on Weeks 16, 24 and 32]

    Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.

40. Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) [Pre-dose on Weeks 16, 20, 24, 28 and 32]

    Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.

41. Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) [Pre-dose on Weeks 16, 24 and 32]

    Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.

42. Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) [Pre-dose on Weeks 16, 20, 24, 28 and 32]

    Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.

43. Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) [Up to Week 32]

    Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC [0-tau]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).

44. Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) [Up to Week 32]

    Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.

45. Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) [Up to Week 32]

    Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.

46. Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) [Up to Week 32]

    Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).

47. Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) [Up to Week 32]

    Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.

48. Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) [Up to Week 32]

    Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.

49. Number of Participants With Treatment-emergent Genotypic Resistance [Up to Week 32]

    Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor [NRTI], Non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI])are presented.

50. Number of Participants With Treatment-emergent Phenotypic Resistance [Up to Week 32]

    Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant.

51. Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) [Up to Week 32]

    Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).

52. Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) [Up to Week 32]

    Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).

53. HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 (Maintenance Period) [Week 32]

    The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks.

54. HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period) [Week 32]

    The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.

55. Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) [Week 32]

    The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects screened for this study must be HIV-1 infected and >=18 years of age.

• A female subject is eligible to enter and participate in the study if she: is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or; is of child-bearing potential with a negative pregnancy test at both Screening and first day of the Induction Period and agrees to use one of the following methods of contraception to avoid pregnancy 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of GSK744 LA and TMC278 LA: Complete abstinence from intercourse (where this is the subject's preferred and usual lifestyle); double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); approved hormonal contraception; any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year; male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; any other method with published data showing that the lowest expected failure rate is <1% per year; any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study must follow safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide) to minimize risk of HIV transmission.

• HIV-1 infection as documented by Screening plasma HIV-1 RNA>=1000 c/mL.

• CD4+ cell count >=200 cells/mm^3 (or higher as local guidelines dictate).

• ART-naive defined as having no more than 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection. Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.

• French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

• Women who are breastfeeding.

• Any evidence at screening of an active Center for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.

• Subjects with known moderate to severe hepatic impairment.

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

• Subject who, in the investigator's judgment, poses a significant suicide risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.

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

• History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic Hepatitis B virus (HBV) infection (HBsAg positive). 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 such therapy during the randomized portion of the study must be excluded.

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

• Ongoing or clinically relevant pancreatitis.

• History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.

• Personal or known family history of prolonged QT syndrome.

• Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug 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.

• Any evidence of primary resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result.

• Any verified Grade 4 laboratory abnormality.

• 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 creatinine clearance <50 mL/min via Cockcroft-Gault method.

• Alanine aminotransferase (ALT) >=5 times Upper limit of normal (ULN). Subjects with ALT >2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and GlaxoSmithKline (GSK) medical monitor the lab abnormality will not interfere with the study procedures or compromise subject safety.

• Alanine aminotransferase (ALT) >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin).

• Any clinically significant finding on screening or Baseline electrocardiograph (ECG), specifically: Heart rate <45 and >100 beats per minute (bpm) (Males) and <50 and >100 bpm (Females) (100 to 110 bpm can be rechecked within 30 minutes to verify eligibility), QRS duration >120 milliseconds (msec), QTc interval (B or F) >450 msec; non-sustained (>=3 consecutive beats) or sustained ventricular tachycardia; sinus pauses >2.5 seconds; 2nd degree (Type II) or higher atrio-ventricular (AV) block; evidence of WPW (Wolff- Parkinson-White) syndrome (ventricular pre-excitation); pathologic Q waves defined as Q wave >40msec OR depth >0.4 mV; any significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator and GSK medical monitor, will interfere with the safety for the individual subject.

• Subjects who are human leukocyte antigen (HLA)-B5701 positive and unable to use an alternative nucleoside reverse transcriptase inhibitor (NRTI) backbone (subjects who are HLA-B5701 positive may be enrolled if they use an alternative NRTI backbone that does not contain abacavir).

• Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.

• Treatment with any of the following agents within 28 days of Screening; radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy and Immunomodulators that alter immune responses (such as systemic corticosteroids, interleukins, or interferons)

• 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 the first dose of IP.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bakersfield	California	United States	93301
2	GSK Investigational Site	Beverly Hills	California	United States	90211
3	GSK Investigational Site	Long Beach	California	United States	90813
4	GSK Investigational Site	Los Angeles	California	United States	90069
5	GSK Investigational Site	Denver	Colorado	United States	80246
6	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
7	GSK Investigational Site	Fort Pierce	Florida	United States	34982
8	GSK Investigational Site	Birmingham	Georgia	United States	35222
9	GSK Investigational Site	Savannah	Georgia	United States	31401
10	GSK Investigational Site	Minneapolis	Minnesota	United States	55415
11	GSK Investigational Site	Omaha	Nebraska	United States	68198
12	GSK Investigational Site	Chapel Hill	North Carolina	United States	27514
13	GSK Investigational Site	Providence	Rhode Island	United States	02904
14	GSK Investigational Site	Austin	Texas	United States	78705
15	GSK Investigational Site	Dallas	Texas	United States	75246
16	GSK Investigational Site	Vancouver	British Columbia	Canada	V6Z 2C7
17	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3A 1R9
18	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 8L6
19	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1K2
20	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4E9
21	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4P9
22	GSK Investigational Site	Montreal	Quebec	Canada	H3A 1T1
23	GSK Investigational Site	Montreal	Quebec	Canada	H4A 3J1
24	GSK Investigational Site	Bobigny		France	93009
25	GSK Investigational Site	Lyon Cedex 03		France	69437
26	GSK Investigational Site	Marseille		France	13274
27	GSK Investigational Site	Nantes		France	44093
28	GSK Investigational Site	Nice		France	06202
29	GSK Investigational Site	Paris Cedex 12		France	75571
30	GSK Investigational Site	Paris Cedex 20		France	75970
31	GSK Investigational Site	Paris		France	75018
32	GSK Investigational Site	Saint Denis Cedex 01		France	93205
33	GSK Investigational Site	Muenchen	Bayern	Germany	80337
34	GSK Investigational Site	Frankfurt	Hessen	Germany	60596
35	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
36	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53127
37	GSK Investigational Site	Berlin		Germany	10439
38	GSK Investigational Site	Berlin		Germany	10787
39	GSK Investigational Site	Berlin		Germany	13353
40	GSK Investigational Site	Hamburg		Germany	20146
41	GSK Investigational Site	Hamburg		Germany	20246
42	GSK Investigational Site	Badalona		Spain	08916
43	GSK Investigational Site	Barcelona		Spain	08025
44	GSK Investigational Site	Barcelona		Spain	08036
45	GSK Investigational Site	Elche		Spain	03203
46	GSK Investigational Site	L'Hospitalet de Llobregat		Spain	08907
47	GSK Investigational Site	Madrid		Spain	28007
48	GSK Investigational Site	Madrid		Spain	28040
49	GSK Investigational Site	Madrid		Spain	28041
50	GSK Investigational Site	Madrid		Spain	28046

Sponsors and Collaborators

• ViiV Healthcare
• Janssen Pharmaceuticals
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

• Study Protocol - Nov 16, 2017
• Statistical Analysis Plan - Mar 5, 2018

More Information

Publications

• Kerrigan D, Mantsios A, Gorgolas M, Montes ML, Pulido F, Brinson C, deVente J, Richmond GJ, Beckham SW, Hammond P, Margolis D, Murray M. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018 Jan 5;13(1):e0190487. doi: 10.1371/journal.pone.0190487. eCollection 2018.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02120352
• Other Study ID Numbers: 200056; 2013-000783-29
• First Posted: Apr 22, 2014
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by ViiV Healthcare: bi-monthly; GSK744; injectable; long acting; maintenance; abacavir; every other month; rilpivirine; HIV-1 infection; integrase inhibitor; TMC278 LA; RPV; non-nucleoside reverse transcriptase inhibitor; LA; once monthly; GSK1265744; induction; treatment satisfication; once daily; lamivudine; adherence; TMC278; therapy-naive
• Additional relevant MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Rilpivirine; Cabotegravir

Study Results

Participant Flow

Recruitment Details	The study was conducted across 50 sites in five countries (United States, Canada, France, Germany and Spain). The results presented are based on interim analysis at Week 32 of maintenance phase.
Pre-assignment Detail	Study consisted of 28 days Screening Period, 20 weeks Induction Period, 96 weeks Maintenance Period (MP), Extension Period (EP) and 52 weeks Long-Term Follow Up Period (LTFP). A total of 309 participants were enrolled in the study and entered in induction period. Of which 288 completed and 286 were qualified and randomized into the MP.

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Period Title: Induction Period (20 Weeks)
STARTED	309	0	0	0
COMPLETED	288	0	0	0
NOT COMPLETED	21	0	0	0
Period Title: Induction Period (20 Weeks)
STARTED	0	115	115	56
COMPLETED	0	0	0	0
NOT COMPLETED	0	115	115	56

Baseline Characteristics

Arm/Group Title	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Overall Participants	309
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	36.6 (10.39)
Sex: Female, Male (Count of Participants)
Female	27 8.7%
Male	282 91.3%
Race/Ethnicity, Customized (Count of Participants)
African American/African Heritage	46 14.9%
American Indian or Alaskan Native	10 3.2%
Asian - Central/South Asian Heritage	1 0.3%
Asian - Japanese Heritage	1 0.3%
Asian - South East Asian Heritage	2 0.6%
Native Hawaiian or Other Pacific Islander	1 0.3%
White - Arabic/North African Heritage	6 1.9%
White - White/Caucasian/European Heritage	240 77.7%
Mixed Race	2 0.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32
Description	Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Number [Percentage of participants]	95 30.7%	94 NaN	91 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA 600 mg+RPV LA 900 mg IM-Q8W, CAB 30 mg+ABC/3TC QD
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 95%; -4.8 to 12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAB LA 400 mg+RPV LA 600 mg IM-Q4W, CAB 30 mg+ABC/3TC QD
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; -5.8 to 11.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD

2. Primary Outcome

Title	Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32
Description	Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Count of Participants [Participants]	1 0.3%	0 NaN	1 NaN

3. Primary Outcome

Title	Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.
Time Frame	Up to 20 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. It consists of all enrolled subjects who received at least one dose of investigational product during induction period.

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	309
Any non-SAE	246 79.6%
Any SAE	8 2.6%

4. Primary Outcome

Title	Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.
Time Frame	Up to an average of 59 weeks

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of investigational product.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Any non-SAE	115 37.2%	113 NaN	52 NaN
Any SAE	9 2.9%	8 NaN	5 NaN

5. Primary Outcome

Title	Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.
Time Frame	Up to an average of 59 weeks

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Any AE with maximum toxicity Grade 1	31 10%	25 NaN	19 NaN
Any AE with maximum toxicity Grade 2	67 21.7%	72 NaN	29 NaN
Any AE with maximum toxicity Grade 3	15 4.9%	14 NaN	3 NaN
Any AE with maximum toxicity Grade 4	2 0.6%	2 NaN	1 NaN

6. Primary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters
Description	Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Time Frame	Up to an average of 59 weeks

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Maximum toxicity Grade 1	94 30.4%	94 NaN	44 NaN
Maximum toxicity Grade 2	50 16.2%	42 NaN	16 NaN
Maximum toxicity Grade 3	15 4.9%	20 NaN	10 NaN
Maximum toxicity Grade 4	10 3.2%	7 NaN	2 NaN

7. Primary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters
Description	Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Time Frame	Up to an average of 59 weeks

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Maximum toxicity Grade 1	23 7.4%	17 NaN	7 NaN
Maximum toxicity Grade 2	2 0.6%	4 NaN	2 NaN
Maximum toxicity Grade 3	0 0%	0 NaN	2 NaN
Maximum toxicity Grade 4	0 0%	3 NaN	0 NaN

8. Primary Outcome

Title	Number of Participants With Post-Baseline Urinalysis Dipstick Results
Description	Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.
Time Frame	Up to an average of 59 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	20	20	10
Urine Occult Blood, Trace, n=10,11,4	5 1.6%	6 NaN	1 NaN
Urine Occult Blood, 1+, n=10,11,4	3 1%	3 NaN	2 NaN
Urine Occult Blood, 2+, n=10,11,4	0 0%	0 NaN	0 NaN
Urine Occult Blood, 3+, n=10,11,4	2 0.6%	2 NaN	1 NaN
Urine Occult Blood, Positive, n=10,11,4	0 0%	0 NaN	0 NaN
Urine Glucose, Trace, n=1,1,1	1 0.3%	0 NaN	0 NaN
Urine Glucose, 1+, n=1,1,1	0 0%	0 NaN	1 NaN
Urine Glucose, 2+, n=1,1,1	0 0%	1 NaN	0 NaN
Urine Glucose, 3+, n=1,1,1	0 0%	0 NaN	0 NaN
Urine Glucose, Positive, n=1,1,1	0 0%	0 NaN	0 NaN
Urine Ketones, Trace, n=16,20,10	12 3.9%	17 NaN	8 NaN
Urine Ketones, 1+, n=16,20,10	4 1.3%	3 NaN	2 NaN
Urine Ketones, 2+, n=16,20,10	0 0%	0 NaN	0 NaN
Urine Ketones, 3+, n=16,20,10	0 0%	0 NaN	0 NaN
Urine Ketones, Positive, n=16,20,10	0 0%	0 NaN	0 NaN
Urine Nitrite, Trace, n=1,3,1	0 0%	0 NaN	0 NaN
Urine Nitrite, 1+, n=1,3,1	0 0%	0 NaN	0 NaN
Urine Nitrite, 2+, n=1,3,1	0 0%	0 NaN	0 NaN
Urine Nitrite, 3+, n=1,3,1	0 0%	0 NaN	0 NaN
Urine Nitrite, Positive, n=1,3,1	1 0.3%	3 NaN	1 NaN
Urine Protein, Trace, n=17,17,7	15 4.9%	11 NaN	2 NaN
Urine Protein, 1+, n=17,17,7	2 0.6%	4 NaN	5 NaN
Urine Protein, 2+, n=17,17,7	0 0%	2 NaN	0 NaN
Urine Protein, 3+, n=17,17,7	0 0%	0 NaN	0 NaN
Urine Protein, Positive, n=17,17,7	0 0%	0 NaN	0 NaN
Urine Leukocyte, Trace, n=20,20,8	8 2.6%	10 NaN	3 NaN
Urine Leukocyte, 1+, n=20,20,8	7 2.3%	8 NaN	3 NaN
Urine Leukocyte, 2+, n=20,20,8	4 1.3%	0 NaN	1 NaN
Urine Leukocyte, 3+, n=20,20,8	1 0.3%	2 NaN	1 NaN
Urine Leukocyte, Positive, n=20,20,8	0 0%	0 NaN	0 NaN

9. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Percentage of participants with HIV-1 RNA <200 c/mL and <50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product.
Time Frame	Week -20, Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	309
HIV-1 RNA<50 c/mL, Week -20	0 0%
HIV-1 RNA<50 c/mL, Week -16	72 23.3%
HIV-1 RNA<50 c/mL, Week -12	90 29.1%
HIV-1 RNA<50 c/mL, Week -8	89 28.8%
HIV-1 RNA<50 c/mL, Week -4	92 29.8%
HIV-1 RNA<50 c/mL, Day 1	91 29.4%
HIV-1 RNA<200 c/mL, Week -20	0 0%
HIV-1 RNA<200 c/mL, Week -16	94 30.4%
HIV-1 RNA<200 c/mL, Week -12	97 31.4%
HIV-1 RNA<200 c/mL, Week -8	96 31.1%
HIV-1 RNA<200 c/mL, Week -4	94 30.4%
HIV-1 RNA<200 c/mL, Day 1	94 30.4%

10. Secondary Outcome

Title	Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented.
Time Frame	Week -20, Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	309
Week -20, n=309	4.43 (0.672)
Week -16, n=304	1.71 (0.229)
Week -12, n=302	1.62 (0.108)
Week -8, n=299	1.63 (0.281)
Week -4, n=294	1.61 (0.080)
Day 1, n=291	1.60 (0.070)

11. Secondary Outcome

Title	Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	304
Week -16, n=304	-2.72 (0.572)
Week -12, n=302	-2.80 (0.640)
Week -8, n=299	-2.79 (0.665)
Week -4, n=294	-2.81 (0.647)
Day 1, n=291	-2.82 (0.645)

12. Secondary Outcome

Title	Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented.
Time Frame	Week -20, Week -16, Week -12, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	309
Week -20, n=309	498.9 (180.67)
Week -16, n=304	630.5 (235.09)
Week -12, n=300	664.2 (256.57)
Week -4, n=292	702.3 (269.60)
Day 1, n=291	690.9 (261.63)

13. Secondary Outcome

Title	Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	304
Week -16, n=304	131.7 (172.69)
Week -12, n=300	164.5 (174.61)
Week -4, n=292	201.5 (195.53)
Day 1, n=291	188.7 (186.69)

14. Secondary Outcome

Title	Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time Frame	Up to 20 Weeks

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of IP.

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	56
Maximum toxicity Grade 1	27 8.7%
Maximum toxicity Grade 2	15 4.9%
Maximum toxicity Grade 3	2 0.6%
Maximum toxicity Grade 4	1 0.3%

15. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Time Frame	Up to Week 20

Outcome Measure Data

Analysis Population Description

Safety Population. It consists of all enrolled subjects who received at least one dose of IP.

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	309
Maximum toxicity Grade 1	26 8.4%
Maximum toxicity Grade 2	4 1.3%
Maximum toxicity Grade 3	1 0.3%
Maximum toxicity Grade 4	3 1%

16. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Description	Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Time Frame	Up to 20 weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	309
Maximum toxicity Grade 1	130 42.1%
Maximum toxicity Grade 2	50 16.2%
Maximum toxicity Grade 3	16 5.2%
Maximum toxicity Grade 4	5 1.6%

17. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	306
ALT, Week -16, n=306	0.4 (33.1)
ALT, Week -12, n=301	-1.3 (14.1)
ALT, Week -8, n=297	-0.5 (16.6)
ALT, Week -4, n=292	1.5 (50.3)
ALT, Day 1, n=287	-1.2 (18.0)
ALP, Week -16, n=306	-2.1 (12.0)
ALP, Week -12, n=301	-2.6 (11.0)
ALP, Week -8, n=297	-1.2 (13.0)
ALP, Week -4, n=292	0.1 (15.4)
ALP, Day 1, n=287	0.1 (14.1)
AST, Week -16, n=306	0.3 (33.4)
AST, Week -12, n=301	-2.2 (13.1)
AST, Week -8, n=296	-1.7 (15.8)
AST, Week -4, n=292	-0.0 (30.9)
AST, Day 1, n=286	-1.0 (25.9)
CK, Week -16, n=306	19.0 (345.6)
CK, Week -12, n=301	29.4 (485.4)
CK, Week -8, n=297	26.3 (529.6)
CK, Week -4, n=292	33.2 (434.2)
CK, Day 1, n=287	69.9 (1164.7)

18. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	306
Week -16, n=306	0.2 (2.3)
Week -12, n=301	0.7 (2.3)
Week -8, n=297	1.4 (2.6)
Week -4, n=292	1.7 (2.6)
Day 1, n=287	1.9 (2.8)

19. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	306
Total Bilirubin, Week -16, n=305	-0.6 (4.5)
Total Bilirubin, Week -12, n=301	-0.9 (4.0)
Total Bilirubin, Week -8, n=297	-1.0 (4.1)
Total Bilirubin, Week -4, n=292	-0.5 (4.1)
Total Bilirubin, Day 1, n=287	-0.3 (4.0)
Creatinine, Week -16, n=306	2.6 (7.6)
Creatinine, Week -12, n=301	1.5 (7.8)
Creatinine, Week -8, n=297	1.6 (7.8)
Creatinine, Week -4, n=292	3.5 (8.7)
Creatinine, Day 1, n=287	4.6 (9.1)

20. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	306
CO2, Week -16, n=306	0.2 (2.4)
CO2, Week -12, n=301	0.3 (2.3)
CO2, Week -8, n=296	0.4 (2.3)
CO2, Week -4, n=292	0.1 (2.3)
CO2, Day 1, n=286	-0.8 (2.6)
Chloride, Week -16, n=306	0.2 (2.3)
Chloride, Week -12, n=301	0.5 (2.2)
Chloride, Week -8, n=297	0.6 (2.3)
Chloride, Week -4, n=292	0.2 (2.3)
Chloride, Day 1, n=287	0.2 (2.3)
Cholesterol, Week -16, n=255	0.21 (0.6)
Cholesterol, Week -12, n=236	0.19 (0.5)
Cholesterol, Week -8, n=235	0.27 (0.5)
Cholesterol, Week -4, n=282	0.34 (0.5)
Cholesterol, Day 1, n=285	0.34 (0.6)
Glucose, Week -16, n=255	0.07 (0.7)
Glucose, Week -12, n=236	0.16 (0.7)
Glucose, Week -8, n=235	0.08 (0.7)
Glucose, Week -4, n=281	0.06 (0.7)
Glucose, Day 1, n=282	-0.01 (0.7)
Potassium, Week -16, n=306	-0.05 (0.2)
Potassium, Week -12, n=301	-0.03 (0.3)
Potassium, Week -8, n=296	0.03 (0.3)
Potassium, Week -4, n=292	0.03 (0.3)
Potassium, Day 1, n=286	0.03 (0.3)
Sodium, Week -16, n=306	-0.1 (1.8)
Sodium, Week -12, n=301	0.1 (1.8)
Sodium, Week -8, n=297	0.2 (1.9)
Sodium, Week -4, n=292	0.4 (2.0)
Sodium, Day 1, n=287	0.3 (1.9)
Triglyceride, Week -16, n=3	-0.69 (0.1)
Triglyceride, Week -12, n=2	-0.37 (0.1)
Triglyceride, Week -8, n=2	0.29 (0.4)
Triglyceride, Week -4, n=278	0.20 (0.9)
Triglyceride, Day 1, n=278	-0.00 (0.7)
Urea, Week -16, n=306	-0.06 (1.2)
Urea, Week -12, n=301	-0.08 (1.2)
Urea, Week -8, n=297	-0.09 (1.1)
Urea, Week -4, n=292	-0.12 (1.3)
Urea, Day 1, n=287	0.00 (1.2)

21. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	306
Week -16, n=306	3.3 (20.0)
Week -12, n=301	0.8 (15.3)
Week -8, n=297	2.8 (24.3)
Week -4, n=292	2.1 (23.8)
Day 1, n=288	-1.2 (17.7)

22. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period)
Description	Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	303
Basophils, Week -16, n=303	0.00 (0.016)
Basophils, Week -12, n=298	0.00 (0.019)
Basophils, Week -8, n=297	0.00 (0.015)
Basophils, Week -4, n=290	0.00 (0.016)
Basophils, Day 1, n=290	0.00 (0.019)
Eosinophils, Week -16, n=303	0.01 (0.131)
Eosinophils, Week -12, n=298	0.01 (0.123)
Eosinophils, Week -8, n=297	0.02 (0.127)
Eosinophils, Week -4, n=290	0.02 (0.136)
Eosinophils, Day 1, n=290	0.03 (0.161)
Lymphocytes, Week -16, n=303	0.24 (0.541)
Lymphocytes, Week -12, n=298	0.28 (0.573)
Lymphocytes, Week -8, n=297	0.30 (0.541)
Lymphocytes, Week -4, n=290	0.30 (0.574)
Lymphocytes, Day 1, n=290	0.14 (0.565)
Monocytes, Week -16, n=303	-0.00 (0.129)
Monocytes, Week -12, n=298	0.00 (0.139)
Monocytes, Week -8, n=297	-0.00 (0.135)
Monocytes, Week -4, n=290	-0.00 (0.132)
Monocytes, Day 1, n=290	0.00 (0.143)
Platelet count, Week -16, n=302	14.4 (31.56)
Platelet count, Week -12, n=300	18.2 (32.53)
Platelet count, Week -8, n=297	21.1 (37.00)
Platelet count, Week -4, n=290	23.0 (35.02)
Platelet count, Day 1, n=290	22.2 (35.32)
Total Neutrophils, Week -16, n=303	0.04 (1.185)
Total Neutrophils, Week -12, n=298	0.22 (1.391)
Total Neutrophils, Week -8, n=297	0.20 (1.286)
Total Neutrophils, Week -4, n=290	0.31 (1.429)
Total Neutrophils, Day 1, n=290	0.38 (1.515)
WBC, Week -16, n=303	0.31 (1.318)
WBC, Week -12, n=298	0.52 (1.522)
WBC, Week -8, n=297	0.54 (1.460)
WBC, Week -4, n=290	0.64 (1.594)
WBC, Day 1, n=290	0.57 (1.713)

23. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit (Induction Period)
Description	Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	304
Week -16, n=304	0.00 (0.022)
Week -12, n=302	0.00 (0.023)
Week -8, n=298	0.00 (0.024)
Week -4, n=290	0.00 (0.025)
Day 1, n=290	0.00 (0.025)

24. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period)
Description	Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	304
Week -16, n=304	0.8 (6.94)
Week -12, n=302	2.0 (7.07)
Week -8, n=298	2.5 (7.42)
Week -4, n=290	3.3 (7.95)
Day 1, n=290	3.1 (7.96)

25. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period)
Description	Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	304
Week -16, n=304	1.0 (1.52)
Week -12, n=302	2.1 (1.90)
Week -8, n=298	3.1 (2.49)
Week -4, n=290	4.0 (2.47)
Day 1, n=290	4.4 (2.57)

26. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period)
Description	Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Measure Participants	304
Week -16, n=304	-0.05 (0.242)
Week -12, n=302	-0.07 (0.254)
Week -8, n=298	-0.10 (0.266)
Week -4, n=290	-0.10 (0.284)
Day 1, n=290	-0.14 (0.289)

27. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 32 (Maintenance Period)
Description	Percentage of participants with HIV-1 RNA <50 c/mL and <200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders.
Time Frame	Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
HIV-1 RNA<50 c/mL, Day 1	95 30.7%	99 NaN	98 NaN
HIV-1 RNA<50 c/mL, Week 4	97 31.4%	98 NaN	93 NaN
HIV-1 RNA<50 c/mL, Week 8	98 31.7%	97 NaN	95 NaN
HIV-1 RNA<50 c/mL, Week 12	96 31.1%	97 NaN	98 NaN
HIV-1 RNA<50 c/mL, Week 16	97 31.4%	96 NaN	89 NaN
HIV-1 RNA<50 c/mL, Week 20	97 31.4%	97 NaN	91 NaN
HIV-1 RNA<50 c/mL, Week 24	96 31.1%	94 NaN	91 NaN
HIV-1 RNA<50 c/mL, Week 28	90 29.1%	92 NaN	86 NaN
HIV-1 RNA<50 c/mL, Week 32	95 30.7%	94 NaN	91 NaN
HIV-1 RNA<200 c/mL, Day 1	100 32.4%	100 NaN	98 NaN
HIV-1 RNA<200 c/mL, Week 4	99 32%	100 NaN	96 NaN
HIV-1 RNA<200 c/mL, Week 8	99 32%	99 NaN	95 NaN
HIV-1 RNA<200 c/mL, Week 12	97 31.4%	98 NaN	98 NaN
HIV-1 RNA<200 c/mL, Week 16	98 31.7%	98 NaN	93 NaN
HIV-1 RNA<200 c/mL, Week 20	98 31.7%	97 NaN	93 NaN
HIV-1 RNA<200 c/mL, Week 24	97 31.4%	96 NaN	93 NaN
HIV-1 RNA<200 c/mL, Week 28	94 30.4%	95 NaN	91 NaN
HIV-1 RNA<200 c/mL, Week 32	97 31.4%	95 NaN	91 NaN

28. Secondary Outcome

Title	Number of Participants With Protocol Defined Virologic Failure at Week 32 (Maintenance Period)
Description	Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Number [Participants]	1 0.3%	0 NaN	1 NaN

29. Secondary Outcome

Title	Absolute Value of Plasma HIV-1 RNA at Week 32 (Maintenance Period)
Description	Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	111	108	50
Mean (Standard Deviation) [Log10 copies per milliliter]	1.60 (0.044)	1.59 (0.025)	1.61 (0.112)

30. Secondary Outcome

Title	Change From Baseline in Plasma HIV-1 RNA at Week 32 (Maintenance Period)
Description	Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	111	108	50
Mean (Standard Deviation) [Log10 copies per milliliter]	-2.78 (0.610)	-2.88 (0.709)	-2.73 (0.561)

31. Secondary Outcome

Title	Absolute Value of CD4+ at Week 32 (Maintenance Period)
Description	Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
Mean (Standard Deviation) [Cells per cubic millimeter]	752.3 (318.02)	761.3 (293.07)	891.3 (273.32)

32. Secondary Outcome

Title	Change From Baseline in CD4+ at Week 32 (Maintenance Period)
Description	Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
Mean (Standard Deviation) [Cells per cubic millimeter]	264.4 (247.84)	263.7 (217.74)	346.1 (219.59)

33. Secondary Outcome

Title	Number of Participants With HIV-1 Disease Progression Over Week 32 (Maintenance Period)
Description	HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
From CDC Stage 1 to CDC Stage 3 Event	1 0.3%	0 NaN	0 NaN
From CDC Stage 2 to CDC Stage 3 Event	0 0%	0 NaN	0 NaN
From CDC Stage 3 to New CDC Stage 3 Event	0 0%	0 NaN	0 NaN
From CDC Stage 1, 2 or 3 to Death	0 0%	1 NaN	0 NaN

34. Secondary Outcome

Title	Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period)
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	115	115	56
Grade 1	35 11.3%	29 NaN	23 NaN
Grade 2	65 21%	69 NaN	22 NaN
Grade 3	14 4.5%	13 NaN	1 NaN
Grade 4	1 0.3%	2 NaN	0 NaN

35. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
ALT	-2.4 (13.4)	-2.7 (13.5)	-5.0 (19.5)
ALP	-1.2 (14.6)	-3.8 (15.0)	-1.3 (11.6)
AST	-2.8 (12.5)	-2.2 (14.5)	-8.3 (30.6)
CK	51.4 (651.0)	93.4 (446.9)	38.8 (394.9)

36. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
Mean (Standard Deviation) [Grams per Liter]	1.4 (3.0)	0.9 (2.9)	1.1 (2.8)

37. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
Total Bilirubin	0.8 (4.4)	0.4 (3.6)	-0.6 (4.4)
Creatinine	2.7 (8.5)	3.8 (8.7)	2.7 (6.1)

38. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
Total CO2, n=112,108,50	-0.8 (2.1)	-1.5 (2.4)	-1.1 (2.4)
Chloride, n=112,108,50	-0.2 (2.2)	-0.3 (2.4)	0.1 (2.1)
Cholesterol, n=109,106,50	0.37 (0.6)	0.47 (0.7)	0.25 (0.5)
Glucose, n=109,106,50	0.13 (1.0)	0.03 (0.7)	-0.05 (0.6)
Potassium, n=112,108,50	0.01 (0.3)	-0.05 (0.3)	-0.04 (0.2)
Sodium, n=112,108,50	0.4 (2.0)	-0.1 (1.8)	0.0 (1.7)
Triglycerides, n=107,105,50	0.08 (0.9)	-0.00 (1.7)	0.06 (0.7)
Urea, n=112,108,50	0.15 (1.3)	0.23 (1.4)	-0.01 (1.4)

39. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	112	108	50
Mean (Standard Deviation) [Units per Liter]	-1.2 (33.2)	-4.4 (15.4)	-3.9 (14.7)

40. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	110	107	48
Basophils, n=110,106,48	0.00 (0.012)	-0.00 (0.022)	0.00 (0.010)
Eosinophils, n=110,106,48	0.01 (0.146)	0.23 (1.985)	-0.01 (0.143)
Lymphocytes, n=110,106,48	0.34 (0.661)	0.26 (0.694)	0.48 (0.635)
Monocytes, n=110,106,48	-0.02 (0.152)	-0.03 (0.144)	-0.00 (0.144)
Platelet count, n=110,107,48	18.7 (38.28)	20.6 (44.93)	11.6 (33.33)
Total Neutrophils, n=110,106,48	0.59 (1.505)	0.34 (1.489)	0.94 (1.365)
WBC count, n=110,106,48	0.93 (1.670)	0.81 (2.881)	1.41 (1.529)

41. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	111	107	48
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.01 (0.026)	0.01 (0.027)	0.01 (0.027)

42. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	111	107	48
Mean (Standard Deviation) [Grams per Liter]	2.0 (8.56)	0.8 (8.45)	1.7 (8.38)

43. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	111	107	48
Mean (Standard Deviation) [Femtoliters]	2.5 (1.97)	2.3 (2.54)	7.1 (2.88)

44. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 (Maintenance Period)
Description	Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time Frame	Baseline (Week -20) and Week 32

Outcome Measure Data

Analysis Population Description

Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	111	107	48
Mean (Standard Deviation) [10^12 cells per Liter]	0.03 (0.286)	0.02 (0.278)	-0.20 (0.296)

45. Secondary Outcome

Title	Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Description	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data.
Time Frame	pre-dose and 2 hours post dose on Day 1, pre-dose on Weeks 1,4,8,12,16,20,24,25,28 and 32

Outcome Measure Data

Analysis Population Description

PK Concentration Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
Measure Participants	115	115
C0	1.43 (54)	2.35 (32)
Cmax	3.55 (56)	3.50 (39)

46. Secondary Outcome

Title	Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Description	Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated.
Time Frame	pre-dose and 2 hours post dose on Day 1, pre-dose on Weeks 1,4,8,12,16,20,24,25,28 and 32

Outcome Measure Data

Analysis Population Description

PK Concentration Population

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
Measure Participants	115	115
C0	49.3 (41)	77.2 (35)
Cmax	104 (47)	111 (40)

47. Secondary Outcome

Title	Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Description	Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
Time Frame	Pre-dose on Weeks 16, 24 and 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.
Measure Participants	87
Week 16, n=87	1.6902 (0.80471)
Week 24, n=86	1.6051 (0.78254)
Week 32, n=84	1.5330 (0.70822)

48. Secondary Outcome

Title	Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Description	Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
Time Frame	Pre-dose on Weeks 16, 20, 24, 28 and 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
Measure Participants	85
Week 16, n=78	2.2703 (0.92102)
Week 20, n=77	2.3861 (0.76176)
Week 24, n=78	2.6342 (1.29093)
Week 28, n=82	2.4365 (0.86420)
Week 32, n=85	2.4715 (0.89893)

49. Secondary Outcome

Title	Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Description	Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
Time Frame	Pre-dose on Weeks 16, 24 and 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.
Measure Participants	87
Week 16, n=87	41.94 (17.575)
Week 24, n=85	47.97 (22.341)
Week 32, n=83	57.24 (22.926)

50. Secondary Outcome

Title	Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Description	Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
Time Frame	Pre-dose on Weeks 16, 20, 24, 28 and 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
Measure Participants	85
Week 16, n=78	66.92 (25.986)
Week 20, n=77	74.55 (29.156)
Week 24, n=78	76.84 (27.976)
Week 28, n=83	80.84 (31.297)
Week 32, n=85	90.34 (34.549)

51. Secondary Outcome

Title	Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Description	Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC [0-tau]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

PK Concentration Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	86	84	0
CAB LA	0.00 (0.001)	0.00 (0.002)
RPV LA	0.00 (0.000)	0.00 (0.000)

52. Secondary Outcome

Title	Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Description	Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	101	108	50
CAB LA, n=100,108, 50	0.64 (0.837)	2.39 (1.903)	0.39 (0.528)
RPV LA, n=101,104,49	0.00 (0.025)	0.01 (0.039)	-0.01 (0.020)

53. Secondary Outcome

Title	Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Description	Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	98	97	0
CAB LA, n=98, 97,0	-0.01 (0.174)	1.64 (1.707)
RPV LA, n=97,96,0	0.00 (0.010)	0.01 (0.027)

54. Secondary Outcome

Title	Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Description	Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

PK Concentration Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	86	84	0
CAB LA	-0.00 (0.001)	-0.00 (0.002)
RPV LA	0.00 (0.000)	-0.00 (0.000)

55. Secondary Outcome

Title	Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Description	Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	101	108	50
CAB LA, n=100,108, 50	-1.01 (1.014)	-2.39 (1.903)	-0.53 (0.796)
RPV LA, n=101,104,49	-0.00 (0.027)	-0.01 (0.039)	-0.01 (0.038)

56. Secondary Outcome

Title	Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Description	Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	98	97	0
CAB LA, n=98, 97,0	-0.45 (0.509)	-1.64 (1.707)
RPV LA, n=97,96,0	-0.00 (0.012)	-0.01 (0.027)

57. Secondary Outcome

Title	Number of Participants With Treatment-emergent Genotypic Resistance
Description	Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor [NRTI], Non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI])are presented.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

On-trt Genotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment genotypic resistance data, at time of protocol defined virologic failure.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	1	0	1
INI mutations	0 0%	0 NaN
Major mutations of other classes	0 0%	0 NaN

58. Secondary Outcome

Title	Number of Participants With Treatment-emergent Phenotypic Resistance
Description	Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant.
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

On-trt Phenotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment phynotypic resistance data, at time of protocol defined virologic failure.

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	1	0	1
INI, Sensitive	1 0.3%	1 NaN
INI, Partially sensitive	0 0%	0 NaN
INI, Resistant	0 0%	0 NaN
NNRTI, Sensitive	1 0.3%	1 NaN
NNRTI, Partially sensitive	0 0%	0 NaN
NNRTI, Resistant	0 0%	0 NaN
NRTI, Sensitive	1 0.3%	1 NaN
NRTI, Partially sensitive	0 0%	0 NaN
NRTI, Resistant	0 0%	0 NaN
PI, Sensitive	1 0.3%	1 NaN
PI, Partially sensitive	0 0%	0 NaN
PI, Resistant	0 0%	0 NaN

59. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period)
Description	Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	99	94	49
Baseline HIV-1 RNA<100000 c/mL, n=99,87,49	96 31.1%	92 NaN	94 NaN
Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7	88 28.5%	100 NaN	71 NaN
Baseline HIV-1 RNA<1000 c/mL, n=0,3,1	100 32.4%	100 NaN
Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13	100 32.4%	84 NaN	92 NaN
Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25	49 15.9%	39 NaN	24 NaN
Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10	87 28.2%	100 NaN	90 NaN
Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2	89 28.8%	100 NaN	50 NaN
Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5	86 27.8%	100 NaN	80 NaN
Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0	100 32.4%	100 NaN
Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8	97 31.4%	100 NaN	88 NaN
Baseline CD4+ count >=350 cells/mm^3, n=82,90,48	94 30.4%	92 NaN	92 NaN
Race-White, n=93,94,39	95 30.7%	94 NaN	95 NaN
Race-Non-White, n=22,21,17	95 30.7%	95 NaN	82 NaN
HC and not injectable drug user, n=98,90,40	96 31.1%	94 NaN	90 NaN
No HC and not injectable drug user, n=17,25,16	88 28.5%	92 NaN	94 NaN

60. Secondary Outcome

Title	Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period)
Description	Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).
Time Frame	Up to Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W	CAB LA 400 mg+RPV LA 600 mg IM-Q4W	CAB 30 mg+ABC/3TC QD
Arm/Group Description	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
Measure Participants	99	94	49
Baseline HIV-1 RNA<100000 c/mL, n=99,87,49	3 1%	1 NaN	0 NaN
Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7	13 4.2%	0 NaN	29 NaN
Baseline HIV-1 RNA<1000 c/mL, n=0,3,1	0 0%	0 NaN
Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13	0 0%	4 NaN	0 NaN
Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25	2 0.6%	0 NaN	0 NaN
Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10	9 2.9%	0 NaN	0 NaN
Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2	11 3.6%	0 NaN	50 NaN
Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5	14 4.5%	0 NaN	20 NaN
Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0	0 0%	0 NaN
Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8	0 0%	0 NaN	13 NaN
Baseline CD4+ count >=350 cells/mm^3, n=82,90,48	6 1.9%	1 NaN	2 NaN
Race-White, n=93,94,39	4 1.3%	1 NaN	0 NaN
Race-Non-White, n=22,21,17	5 1.6%	0 NaN	12 NaN
HC and not injectable drug user, n=98,90,40	3 1%	1 NaN	5 NaN
No HC and not injectable drug user, n=17,25,16	12 3.9%	0 NaN	0 NaN

61. Secondary Outcome

Title	HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 (Maintenance Period)
Description	The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	109	106	50
Mean (Standard Deviation) [Scores on a scale]	68.4 (4.48)	66.6 (6.47)	65.1 (5.83)

62. Secondary Outcome

Title	HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period)
Description	The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	106	100	49
Mean (Standard Deviation) [Scores on a scale]	30.9 (7.56)	28.9 (8.53)	20.5 (14.09)

63. Secondary Outcome

Title	Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period)
Description	The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented.
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

ITT-ME Population. Only those participants available at the specified time points were analyzed

Arm/Group Title	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)	CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.	On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
Measure Participants	109	106	50
Item E, score 0	80 25.9%	73 NaN	16 NaN
Item E, score 1	12 3.9%	14 NaN	13 NaN
Item E, score 2	3 1%	2 NaN	2 NaN
Item E, score 3	2 0.6%	6 NaN	3 NaN
Item E, score 4	0 0%	1 NaN	1 NaN
Item E, score 5	2 0.6%	4 NaN	12 NaN
Item E, score 6	10 3.2%	6 NaN	3 NaN
Item F, Score 0	40 12.9%	33 NaN	29 NaN
Item F, Score 1	35 11.3%	43 NaN	12 NaN
Item F, Score 2	17 5.5%	16 NaN	2 NaN
Item F, Score 3	6 1.9%	5 NaN	2 NaN
Item F, Score 4	7 2.3%	3 NaN	3 NaN
Item F, Score 5	4 1.3%	4 NaN	0 NaN
Item F, Score 6	0 0%	2 NaN	2 NaN

Adverse Events

Time Frame	Non-SAEs and SAEs were collected from start of the study treatment up to an average of 59 weeks.
Adverse Event Reporting Description	Non-SAEs and SAEs are presented for Safety Maintenance Population. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.
Arm/Group Title	CAB 30 mg+ABC/3TC QD (Induction Period)		CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)		CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)		CAB 30 mg+ABC/3TC QD (Maintenance Period)
Arm/Group Description	In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.		On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.		On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.		On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
All Cause Mortality
	CAB 30 mg+ABC/3TC QD (Induction Period)		CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)		CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)		CAB 30 mg+ABC/3TC QD (Maintenance Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Serious Adverse Events
	CAB 30 mg+ABC/3TC QD (Induction Period)		CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)		CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)		CAB 30 mg+ABC/3TC QD (Maintenance Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/309 (2.6%)		9/115 (7.8%)		8/115 (7%)		5/56 (8.9%)
Cardiac disorders
Myocardial infarction	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Gastrointestinal disorders
Gastritis	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Hepatobiliary disorders
Drug-induced liver injury	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Immune system disorders
Allergic granulomatous angiitis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Infections and infestations
Abscess limb	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Anal abscess	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Epididymitis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Orchitis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Peritonsillar abscess	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Pneumonia	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Gastroenteritis	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Injury, poisoning and procedural complications
Overdose	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Epicondylitis	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Mountain sickness acute	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Multiple injuries	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Road traffic accident	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Uterine perforation	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Musculoskeletal and connective tissue disorders
Fistula	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Muscular weakness	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Neck pain	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Pain in extremity	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Rib fracture	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Nervous system disorders
Epilepsy	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Headache	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Migraine	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Nerve root compression	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Psychiatric disorders
Suicide attempt	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Substance abuse	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Renal and urinary disorders
Nephrolithiasis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Reproductive system and breast disorders
Ovarian cyst	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Vascular disorders
Hypertension	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	CAB 30 mg+ABC/3TC QD (Induction Period)		CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)		CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)		CAB 30 mg+ABC/3TC QD (Maintenance Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	246/309 (79.6%)		115/115 (100%)		113/115 (98.3%)		52/56 (92.9%)
Blood and lymphatic system disorders
Anaemia	2/309 (0.6%)		0/115 (0%)		0/115 (0%)		4/56 (7.1%)
Lymphadenopathy	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Neutropenia	2/309 (0.6%)		0/115 (0%)		0/115 (0%)		2/56 (3.6%)
Eosinophilia	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Leukocytosis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Necrotising granulomatous lymphadenitis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Cardiac disorders
Palpitations	2/309 (0.6%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Tachycardia	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Hypertensive heart disease	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Mitral valve incompetence	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Myocardial infarction	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Ventricular dyskinesia	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Ear and labyrinth disorders
Ear pain	2/309 (0.6%)		0/115 (0%)		1/115 (0.9%)		2/56 (3.6%)
Vertigo	0/309 (0%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Deafness	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Tympanic membrane disorder	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Tympanic membrane perforation	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Eye disorders
Eye pruritus	2/309 (0.6%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Conjunctivitis allergic	1/309 (0.3%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Blepharitis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Chalazion	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Chromatopsia	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Conjunctival haemorrhage	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Dry eye	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Erythema of eyelid	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Keratitis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Ocular hyperaemia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Photophobia	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Vision blurred	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Gastrointestinal disorders
Diarrhoea	34/309 (11%)		22/115 (19.1%)		28/115 (24.3%)		9/56 (16.1%)
Nausea	38/309 (12.3%)		14/115 (12.2%)		15/115 (13%)		9/56 (16.1%)
Abdominal pain	9/309 (2.9%)		9/115 (7.8%)		4/115 (3.5%)		4/56 (7.1%)
Vomiting	6/309 (1.9%)		3/115 (2.6%)		7/115 (6.1%)		4/56 (7.1%)
Dyspepsia	13/309 (4.2%)		4/115 (3.5%)		7/115 (6.1%)		1/56 (1.8%)
Constipation	5/309 (1.6%)		4/115 (3.5%)		4/115 (3.5%)		2/56 (3.6%)
Odynophagia	6/309 (1.9%)		4/115 (3.5%)		2/115 (1.7%)		3/56 (5.4%)
Abdominal distension	4/309 (1.3%)		4/115 (3.5%)		3/115 (2.6%)		1/56 (1.8%)
Gastrooesophageal reflux disease	2/309 (0.6%)		2/115 (1.7%)		5/115 (4.3%)		0/56 (0%)
Haemorrhoids	2/309 (0.6%)		5/115 (4.3%)		1/115 (0.9%)		1/56 (1.8%)
Proctitis	1/309 (0.3%)		2/115 (1.7%)		2/115 (1.7%)		2/56 (3.6%)
Abdominal discomfort	5/309 (1.6%)		2/115 (1.7%)		2/115 (1.7%)		1/56 (1.8%)
Proctalgia	2/309 (0.6%)		4/115 (3.5%)		1/115 (0.9%)		0/56 (0%)
Abdominal pain upper	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		1/56 (1.8%)
Anal fissure	2/309 (0.6%)		2/115 (1.7%)		0/115 (0%)		2/56 (3.6%)
Rectal haemorrhage	1/309 (0.3%)		1/115 (0.9%)		3/115 (2.6%)		0/56 (0%)
Anogenital dysplasia	1/309 (0.3%)		3/115 (2.6%)		0/115 (0%)		0/56 (0%)
Flatulence	1/309 (0.3%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Gastritis	2/309 (0.6%)		1/115 (0.9%)		1/115 (0.9%)		1/56 (1.8%)
Oral disorder	3/309 (1%)		0/115 (0%)		3/115 (2.6%)		0/56 (0%)
Anal pruritus	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		1/56 (1.8%)
Aphthous stomatitis	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Dental caries	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Faeces soft	2/309 (0.6%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Frequent bowel movements	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Toothache	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Abdominal pain lower	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Anal ulcer	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Anorectal discomfort	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Cheilosis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Dysphagia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Enteritis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Erosive duodenitis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Food poisoning	2/309 (0.6%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Gastrointestinal disorder	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Gingival oedema	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Gingival pain	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Glossitis	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Haemorrhoids thrombosed	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Irritable bowel syndrome	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Large intestine polyp	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Lip oedema	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Lip swelling	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Lip ulceration	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Loose tooth	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Noninfective gingivitis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Palatal disorder	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Perianal erythema	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Rectal discharge	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Tongue discolouration	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Tongue ulceration	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Umbilical hernia	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Gastric disorder	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
General disorders
Injection site pain	0/309 (0%)		106/115 (92.2%)		106/115 (92.2%)		0/56 (0%)
Injection site swelling	0/309 (0%)		28/115 (24.3%)		30/115 (26.1%)		0/56 (0%)
Injection site nodule	0/309 (0%)		21/115 (18.3%)		28/115 (24.3%)		0/56 (0%)
Injection site induration	0/309 (0%)		22/115 (19.1%)		20/115 (17.4%)		0/56 (0%)
Injection site pruritus	0/309 (0%)		19/115 (16.5%)		18/115 (15.7%)		0/56 (0%)
Injection site warmth	0/309 (0%)		17/115 (14.8%)		16/115 (13.9%)		0/56 (0%)
Fatigue	19/309 (6.1%)		11/115 (9.6%)		14/115 (12.2%)		4/56 (7.1%)
Pyrexia	9/309 (2.9%)		13/115 (11.3%)		11/115 (9.6%)		3/56 (5.4%)
Injection site bruising	0/309 (0%)		15/115 (13%)		10/115 (8.7%)		0/56 (0%)
Asthenia	11/309 (3.6%)		6/115 (5.2%)		8/115 (7%)		9/56 (16.1%)
Injection site erythema	0/309 (0%)		9/115 (7.8%)		11/115 (9.6%)		0/56 (0%)
Influenza like illness	1/309 (0.3%)		3/115 (2.6%)		5/115 (4.3%)		0/56 (0%)
Injection site discolouration	0/309 (0%)		2/115 (1.7%)		3/115 (2.6%)		0/56 (0%)
Injection site haematoma	0/309 (0%)		2/115 (1.7%)		2/115 (1.7%)		0/56 (0%)
Chest pain	2/309 (0.6%)		0/115 (0%)		2/115 (1.7%)		1/56 (1.8%)
Malaise	2/309 (0.6%)		1/115 (0.9%)		0/115 (0%)		1/56 (1.8%)
Pain	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Chest discomfort	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Chills	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Cyst	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Discomfort	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Energy increased	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Feeling hot	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Injection site anaesthesia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Injection site hypoaesthesia	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Injection site inflammation	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Injection site paraesthesia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Injection site rash	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Injection site reaction	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Oedema	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Peripheral swelling	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Secretion discharge	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Temperature intolerance	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Cyst rupture	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Hepatobiliary disorders
Hepatic steatosis	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Gallbladder polyp	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Hepatotoxicity	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Immune system disorders
Seasonal allergy	1/309 (0.3%)		3/115 (2.6%)		3/115 (2.6%)		0/56 (0%)
Allergy to arthropod bite	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Hypersensitivity	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Multiple allergies	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Infections and infestations
Nasopharyngitis	27/309 (8.7%)		27/115 (23.5%)		32/115 (27.8%)		15/56 (26.8%)
Upper respiratory tract infection	11/309 (3.6%)		18/115 (15.7%)		9/115 (7.8%)		3/56 (5.4%)
Syphilis	6/309 (1.9%)		10/115 (8.7%)		8/115 (7%)		3/56 (5.4%)
Gastroenteritis	4/309 (1.3%)		7/115 (6.1%)		10/115 (8.7%)		3/56 (5.4%)
Bronchitis	6/309 (1.9%)		8/115 (7%)		6/115 (5.2%)		4/56 (7.1%)
Pharyngitis	4/309 (1.3%)		9/115 (7.8%)		6/115 (5.2%)		1/56 (1.8%)
Influenza	5/309 (1.6%)		6/115 (5.2%)		9/115 (7.8%)		0/56 (0%)
Respiratory tract infection	5/309 (1.6%)		4/115 (3.5%)		5/115 (4.3%)		6/56 (10.7%)
Gonorrhoea	2/309 (0.6%)		7/115 (6.1%)		5/115 (4.3%)		0/56 (0%)
Rhinitis	3/309 (1%)		3/115 (2.6%)		4/115 (3.5%)		3/56 (5.4%)
Tonsillitis	5/309 (1.6%)		4/115 (3.5%)		4/115 (3.5%)		2/56 (3.6%)
Oral herpes	3/309 (1%)		2/115 (1.7%)		5/115 (4.3%)		2/56 (3.6%)
Sinusitis	5/309 (1.6%)		4/115 (3.5%)		2/115 (1.7%)		3/56 (5.4%)
Urethritis	3/309 (1%)		3/115 (2.6%)		6/115 (5.2%)		0/56 (0%)
Conjunctivitis	4/309 (1.3%)		3/115 (2.6%)		2/115 (1.7%)		3/56 (5.4%)
Pharyngotonsillitis	7/309 (2.3%)		6/115 (5.2%)		1/115 (0.9%)		1/56 (1.8%)
Cellulitis	3/309 (1%)		3/115 (2.6%)		4/115 (3.5%)		0/56 (0%)
Chlamydial infection	3/309 (1%)		4/115 (3.5%)		3/115 (2.6%)		0/56 (0%)
Folliculitis	5/309 (1.6%)		6/115 (5.2%)		1/115 (0.9%)		0/56 (0%)
Ear infection	1/309 (0.3%)		3/115 (2.6%)		3/115 (2.6%)		0/56 (0%)
Genital herpes	2/309 (0.6%)		6/115 (5.2%)		0/115 (0%)		0/56 (0%)
Tinea pedis	2/309 (0.6%)		2/115 (1.7%)		3/115 (2.6%)		1/56 (1.8%)
Viral infection	1/309 (0.3%)		2/115 (1.7%)		2/115 (1.7%)		2/56 (3.6%)
Hordeolum	3/309 (1%)		1/115 (0.9%)		3/115 (2.6%)		1/56 (1.8%)
Pharyngitis streptococcal	2/309 (0.6%)		2/115 (1.7%)		3/115 (2.6%)		0/56 (0%)
Subcutaneous abscess	0/309 (0%)		3/115 (2.6%)		2/115 (1.7%)		0/56 (0%)
Tooth infection	3/309 (1%)		2/115 (1.7%)		3/115 (2.6%)		0/56 (0%)
Acute sinusitis	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		1/56 (1.8%)
Gingivitis	2/309 (0.6%)		3/115 (2.6%)		0/115 (0%)		1/56 (1.8%)
Herpes zoster	1/309 (0.3%)		0/115 (0%)		4/115 (3.5%)		0/56 (0%)
Lymphogranuloma venereum	1/309 (0.3%)		2/115 (1.7%)		2/115 (1.7%)		0/56 (0%)
Acute hepatitis C	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		1/56 (1.8%)
Fungal infection	1/309 (0.3%)		2/115 (1.7%)		0/115 (0%)		1/56 (1.8%)
Furuncle	2/309 (0.6%)		1/115 (0.9%)		1/115 (0.9%)		1/56 (1.8%)
Gastroenteritis viral	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		2/56 (3.6%)
Hepatitis C	1/309 (0.3%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Proctitis chlamydial	2/309 (0.6%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Secondary syphilis	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Tinea versicolour	1/309 (0.3%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Urinary tract infection	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		1/56 (1.8%)
Acarodermatitis	1/309 (0.3%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Anal chlamydia infection	1/309 (0.3%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Cystitis	2/309 (0.6%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Enterobiasis	2/309 (0.6%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Fungal skin infection	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Giardiasis	2/309 (0.6%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Herpes simplex	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Herpes virus infection	2/309 (0.6%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Lung infection	2/309 (0.6%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Onychomycosis	0/309 (0%)		0/115 (0%)		0/115 (0%)		2/56 (3.6%)
Oropharyngeal gonococcal infection	0/309 (0%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Pneumonia	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Skin infection	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Tooth abscess	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Viral upper respiratory tract infection	0/309 (0%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
AIDS dementia complex	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Abscess	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Abscess limb	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Acute tonsillitis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Anal infection	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Anorectal human papilloma virus infection	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Blastocystis infection	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Body tinea	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Bronchitis bacterial	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Carbuncle	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Cervicitis	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Chronic sinusitis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Cryptosporidiosis infection	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Diarrhoea infectious	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Epididymitis	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Escherichia urinary tract infection	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Eye infection	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Gastroenteritis norovirus	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Gastrointestinal infection	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Genital infection bacterial	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Haemophilus infection	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Hand-foot-and-mouth disease	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Hepatitis syphilitic	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Herpes ophthalmic	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Impetigo	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Infection	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Injection site abscess	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Lice infestation	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Lower respiratory tract infection	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Molluscum contagiosum	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Oral candidiasis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Osteomyelitis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Otitis externa	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Otitis media	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Pilonidal cyst	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Proctitis gonococcal	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Respiratory tract infection bacterial	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Respiratory tract infection viral	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Rhinovirus infection	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Shigella infection	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Spirochaetal infection	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Tracheobronchitis	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Urethritis chlamydial	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Urethritis gonococcal	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Vaginal infection	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Viral tonsillitis	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Visceral leishmaniasis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Vulvovaginitis trichomonal	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Injury, poisoning and procedural complications
Ligament sprain	1/309 (0.3%)		1/115 (0.9%)		4/115 (3.5%)		0/56 (0%)
Contusion	0/309 (0%)		0/115 (0%)		4/115 (3.5%)		0/56 (0%)
Wound	2/309 (0.6%)		1/115 (0.9%)		1/115 (0.9%)		2/56 (3.6%)
Arthropod bite	2/309 (0.6%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Hand fracture	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		1/56 (1.8%)
Joint injury	0/309 (0%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Limb injury	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		1/56 (1.8%)
Post-traumatic neck syndrome	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Post-traumatic pain	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Tendon rupture	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Compression fracture	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Epicondylitis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Exposure to communicable disease	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Fall	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Foot fracture	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Injury	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Joint dislocation	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Ligament rupture	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Muscle contusion	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Periorbital contusion	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Procedural complication	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Rib fracture	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Scratch	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Thermal burn	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Investigations
Blood creatine phosphokinase increased	3/309 (1%)		3/115 (2.6%)		3/115 (2.6%)		2/56 (3.6%)
Lipase increased	2/309 (0.6%)		2/115 (1.7%)		1/115 (0.9%)		1/56 (1.8%)
Transaminases increased	4/309 (1.3%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Blood creatinine increased	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Blood pressure increased	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Eosinophil count decreased	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Lymphocyte count increased	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Weight decreased	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Weight increased	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Metabolism and nutrition disorders
Hypercholesterolaemia	3/309 (1%)		2/115 (1.7%)		4/115 (3.5%)		1/56 (1.8%)
Decreased appetite	1/309 (0.3%)		3/115 (2.6%)		1/115 (0.9%)		0/56 (0%)
Vitamin D deficiency	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		1/56 (1.8%)
Hypertriglyceridaemia	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Carbohydrate intolerance	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Diabetes mellitus	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Glucose tolerance impaired	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Hyperglycaemia	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Increased appetite	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Vitamin B complex deficiency	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Hyperlipidaemia	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Musculoskeletal and connective tissue disorders
Back pain	10/309 (3.2%)		12/115 (10.4%)		7/115 (6.1%)		4/56 (7.1%)
Myalgia	4/309 (1.3%)		6/115 (5.2%)		5/115 (4.3%)		1/56 (1.8%)
Arthralgia	2/309 (0.6%)		4/115 (3.5%)		4/115 (3.5%)		2/56 (3.6%)
Pain in extremity	3/309 (1%)		3/115 (2.6%)		3/115 (2.6%)		0/56 (0%)
Musculoskeletal pain	4/309 (1.3%)		4/115 (3.5%)		1/115 (0.9%)		0/56 (0%)
Muscle spasms	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		1/56 (1.8%)
Musculoskeletal chest pain	2/309 (0.6%)		2/115 (1.7%)		1/115 (0.9%)		1/56 (1.8%)
Neck pain	0/309 (0%)		1/115 (0.9%)		2/115 (1.7%)		1/56 (1.8%)
Musculoskeletal stiffness	1/309 (0.3%)		3/115 (2.6%)		0/115 (0%)		0/56 (0%)
Chondropathy	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		2/56 (3.6%)
Groin pain	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Intervertebral disc protrusion	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Muscle contracture	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		1/56 (1.8%)
Dactylitis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Extremity contracture	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Finger deformity	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Fistula	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Joint effusion	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Joint swelling	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Osteoarthritis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Osteochondrosis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Osteoporosis	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Rotator cuff syndrome	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Synovial cyst	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Tenosynovitis	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	6/309 (1.9%)		7/115 (6.1%)		9/115 (7.8%)		2/56 (3.6%)
Skin papilloma	4/309 (1.3%)		5/115 (4.3%)		3/115 (2.6%)		1/56 (1.8%)
Benign salivary gland neoplasm	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Kaposi's sarcoma	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Oral papilloma	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Nervous system disorders
Headache	27/309 (8.7%)		24/115 (20.9%)		24/115 (20.9%)		10/56 (17.9%)
Dizziness	12/309 (3.9%)		6/115 (5.2%)		6/115 (5.2%)		2/56 (3.6%)
Paraesthesia	4/309 (1.3%)		1/115 (0.9%)		2/115 (1.7%)		2/56 (3.6%)
Hypersomnia	3/309 (1%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Aphonia	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Hypoaesthesia	1/309 (0.3%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Migraine	1/309 (0.3%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Presyncope	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Sciatica	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Vagus nerve disorder	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Amnesia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Dysaesthesia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Dysgeusia	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Loss of consciousness	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Memory impairment	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Nerve root compression	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Parosmia	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Polyneuropathy	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Poor quality sleep	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Restless legs syndrome	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Tremor	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Psychiatric disorders
Insomnia	12/309 (3.9%)		9/115 (7.8%)		10/115 (8.7%)		3/56 (5.4%)
Anxiety	11/309 (3.6%)		7/115 (6.1%)		10/115 (8.7%)		2/56 (3.6%)
Depression	9/309 (2.9%)		6/115 (5.2%)		6/115 (5.2%)		5/56 (8.9%)
Abnormal dreams	4/309 (1.3%)		2/115 (1.7%)		3/115 (2.6%)		2/56 (3.6%)
Depressed mood	3/309 (1%)		2/115 (1.7%)		0/115 (0%)		3/56 (5.4%)
Irritability	2/309 (0.6%)		4/115 (3.5%)		0/115 (0%)		0/56 (0%)
Nightmare	2/309 (0.6%)		1/115 (0.9%)		3/115 (2.6%)		0/56 (0%)
Libido decreased	2/309 (0.6%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Affect lability	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Affective disorder	2/309 (0.6%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Anxiety disorder	2/309 (0.6%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Psychotic disorder	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Abnormal behaviour	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Acute stress disorder	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Agitation	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Apathy	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Initial insomnia	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Libido increased	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Mood altered	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Mood swings	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Nervousness	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Panic attack	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Paranoia	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Personality disorder	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Sleep disorder	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Stress	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Suicidal ideation	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Tachyphrenia	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Trichotillomania	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Renal and urinary disorders
Dysuria	4/309 (1.3%)		2/115 (1.7%)		3/115 (2.6%)		0/56 (0%)
Nephrolithiasis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		1/56 (1.8%)
Haematuria	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Nephropathy toxic	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Renal colic	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Reproductive system and breast disorders
Erectile dysfunction	0/309 (0%)		1/115 (0.9%)		3/115 (2.6%)		0/56 (0%)
Balanoposthitis	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Genital lesion	2/309 (0.6%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Haematospermia	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Prostatitis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Testis discomfort	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Vaginal discharge	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	7/309 (2.3%)		8/115 (7%)		11/115 (9.6%)		3/56 (5.4%)
Oropharyngeal pain	2/309 (0.6%)		1/115 (0.9%)		5/115 (4.3%)		1/56 (1.8%)
Rhinitis allergic	0/309 (0%)		3/115 (2.6%)		3/115 (2.6%)		0/56 (0%)
Catarrh	5/309 (1.6%)		3/115 (2.6%)		1/115 (0.9%)		1/56 (1.8%)
Rhinorrhoea	1/309 (0.3%)		1/115 (0.9%)		2/115 (1.7%)		2/56 (3.6%)
Nasal congestion	1/309 (0.3%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Sinus congestion	2/309 (0.6%)		2/115 (1.7%)		0/115 (0%)		1/56 (1.8%)
Allergic sinusitis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Asthma	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Chronic obstructive pulmonary disease	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Dysphonia	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Dyspnoea	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Oropharyngeal discomfort	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Pharyngeal erythema	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Pleuritic pain	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Productive cough	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Skin and subcutaneous tissue disorders
Rash	6/309 (1.9%)		6/115 (5.2%)		6/115 (5.2%)		1/56 (1.8%)
Eczema	4/309 (1.3%)		5/115 (4.3%)		0/115 (0%)		3/56 (5.4%)
Pruritus	2/309 (0.6%)		4/115 (3.5%)		3/115 (2.6%)		0/56 (0%)
Night sweats	2/309 (0.6%)		2/115 (1.7%)		2/115 (1.7%)		1/56 (1.8%)
Skin induration	0/309 (0%)		2/115 (1.7%)		2/115 (1.7%)		0/56 (0%)
Urticaria	0/309 (0%)		1/115 (0.9%)		2/115 (1.7%)		1/56 (1.8%)
Acne	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Dermatitis	2/309 (0.6%)		1/115 (0.9%)		2/115 (1.7%)		0/56 (0%)
Dry skin	1/309 (0.3%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Hyperhidrosis	4/309 (1.3%)		1/115 (0.9%)		1/115 (0.9%)		1/56 (1.8%)
Intertrigo	0/309 (0%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Papule	2/309 (0.6%)		2/115 (1.7%)		1/115 (0.9%)		0/56 (0%)
Seborrhoeic dermatitis	1/309 (0.3%)		3/115 (2.6%)		0/115 (0%)		0/56 (0%)
Alopecia	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Hyperkeratosis	0/309 (0%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Photosensitivity reaction	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		1/56 (1.8%)
Rash maculo-papular	0/309 (0%)		2/115 (1.7%)		0/115 (0%)		0/56 (0%)
Rosacea	1/309 (0.3%)		0/115 (0%)		2/115 (1.7%)		0/56 (0%)
Skin lesion	2/309 (0.6%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Alopecia areata	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Dermal cyst	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Dermatitis allergic	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Dermatitis contact	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Dyshidrotic eczema	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Hidradenitis	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Nail discolouration	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Onycholysis	0/309 (0%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Penile ulceration	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Pityriasis	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Psoriasis	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Rash papular	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Rash vesicular	1/309 (0.3%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Skin plaque	1/309 (0.3%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Social circumstances
Stress at work	1/309 (0.3%)		1/115 (0.9%)		1/115 (0.9%)		0/56 (0%)
Surgical and medical procedures
Dental care	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Tooth extraction	2/309 (0.6%)		0/115 (0%)		0/115 (0%)		0/56 (0%)
Vascular disorders
Hypertension	1/309 (0.3%)		4/115 (3.5%)		2/115 (1.7%)		0/56 (0%)
Deep vein thrombosis	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Flushing	1/309 (0.3%)		1/115 (0.9%)		0/115 (0%)		0/56 (0%)
Haematoma	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)
Lymphoedema	0/309 (0%)		0/115 (0%)		0/115 (0%)		1/56 (1.8%)
Thrombophlebitis superficial	0/309 (0%)		0/115 (0%)		1/115 (0.9%)		0/56 (0%)

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.