Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

Sponsor

ViiV Healthcare (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03639311

Collaborator

Janssen, LP (Industry)

Enrollment

Locations

Arms

52.6

Anticipated Duration (Months)

3.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than [<]50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regimen receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 participants. Any participant who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those participants must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: CAB LA Drug: RPV LA Drug: RPV Drug: DTG	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.

Masking:

None (Open Label)

Masking Description:

This is an open-label study, thus no masking.

Primary Purpose:

Treatment

Official Title:

A Phase IIb, Multicenter, Open-label, Rollover Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months in HIV-1 Infected Adults Who Are Virologically Suppressed and Participated in Study LAI116482

Actual Study Start Date :

Aug 20, 2018

Actual Primary Completion Date :

Dec 11, 2019

Anticipated Study Completion Date :

Jan 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants receiving Injection CAB LA plus RPV LA The eligible participants in the arm (participants from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections will be administered 1 month after initial loading dose (CAB LA 600 mg plus RPV LA 900 mg), with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants will continue to receive the treatment until the study intervention is locally approved and commercially available. HAART therapy will be initiated within 8 weeks after the last Q2M injection.	Drug: CAB LA Administered CAB LA (600 mg) Q2M, as intramuscular injection. Drug: RPV LA Administered RPV LA (900 mg), Q2M, as intramuscular injection.
Experimental: Participants receiving Oral DTG plus RPV The eligible participants in the arm (participants from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose of the DTG 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants will continue to receive the treatment until the study intervention is locally approved and commercially available.	Drug: RPV Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12 Drug: DTG Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.

Arm

Intervention/Treatment

Experimental: Participants receiving Injection CAB LA plus RPV LA

The eligible participants in the arm (participants from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections will be administered 1 month after initial loading dose (CAB LA 600 mg plus RPV LA 900 mg), with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants will continue to receive the treatment until the study intervention is locally approved and commercially available. HAART therapy will be initiated within 8 weeks after the last Q2M injection.

Drug: CAB LA

Administered CAB LA (600 mg) Q2M, as intramuscular injection.

Drug: RPV LA

Administered RPV LA (900 mg), Q2M, as intramuscular injection.

Experimental: Participants receiving Oral DTG plus RPV

The eligible participants in the arm (participants from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose of the DTG 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants will continue to receive the treatment until the study intervention is locally approved and commercially available.

Drug: RPV

Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12

Drug: DTG

Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.

Outcome Measures

Primary Outcome Measures

Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Month 12]
Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received.

Secondary Outcome Measures

Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Month 12]
Percentage of participants with HIV-1 RNA <50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Percentage of Participants With Protocol-defined Confirmed Virologic Failure Overtime [Up to Month 12]
Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12]
Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Absolute Values for HIV-1 RNA of DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Change From Baseline in HIV-1 RNA for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 6, 8, and 12]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Absolute Values for CD4+ for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 6, 8, and 12]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Change From Baseline Values for CD4+ for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) [Up to Month 17]
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
Number of Participants With Severity of Adverse Events [Up to Month 17]
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Number of Participants With Maximum Post-Baseline Chemistry Toxicities [Up to Month 12]
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Number of Participants With Maximum Post-Baseline Hematology Toxicities [Up to Month 12]
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Percentage of Participants Who Permanently Discontinued Treatment Due to Adverse Events [Up to Month 12]
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to permanent withdrawal has been presented.
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase Over Time for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for DTG+ RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for DTG+ RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, LDL Cholesterol Direct and Triglycerides for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Month 12]
Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, direct HDL cholesterol, LDL cholesterol calculation, direct LDL cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm [At Day 1]
Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of clinical chemical parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Month 12]
Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm [Baseline (Day 1) and at Month 6]
Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm [Baseline (Day 1) and at Months 2, 4, 8 and 12]
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm [Baseline (Day 1) and at Months 3, 6, 9 and 12]
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio [At Day 1]
Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.
Absolute Values of Urine Creatinine [At Day 1]
Urine samples were collected for the analysis of urine creatinine.
Absolute Values of Urine Phosphate [At Day 1]
Urine samples were collected for the analysis of urine phosphate.
Absolute Values of Urine Specific Gravity [At Day 1]
Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Absolute Values of Urine Potential of Hydrogen (pH) [At Day 1]
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Number of Participants With Treatment Emergent Genotypic Resistance [Up to Month 12]
Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.
Number of Participants With Treatment Emergent Phenotypic Resistance [Up to Month 12]
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) [Baseline (Day 1) and at Months 6 and 12]
HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted impact score was calculated for 26 individual domain items by multiplying impact score (-3[maximum negative impact] to +1[maximum positive impact] by the corresponding importance score (3 [very important] to 0[not all important]). Average Weighted impact (AWI) score was calculated by summing individual weighted impact scores and dividing by the number of domain items. The ranges of weighted impact score and average impact score were from -9(maximum negative impact) to +3(maximum positive impact); higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value).
Change From Baseline in Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) [Baseline (Day 1) and at Months 6 and 12]
HIVTSQs total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Individual Item Score of HIVTSQs [Baseline (Day 1) and at Months 6 and 12]
HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.
Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) [At Month 12]
HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and remain missing.

Other Outcome Measures

Plasma Trough Concentration (Ctrough) for CAB LA [Pre-dose (Day 1) and Month 12]
Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted.
Ctrough for RPV LA [Pre-dose (Day 1) and Month 12]
Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.
A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test at Day 1), not lactating, and at least with one of following conditions:

(a) Non-reproductive potential defined as: (i) Pre-menopausal females with one of the conditions as documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy.

(ii) Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

(b) Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA.

The investigator is responsible for ensuring that participants understand how to properly use the methods of contraception.
Capable of giving signed informed consent.
Must have been on oral CAB 30 mg plus RPV 25 mg regimen through at minimum Week 300 of the LATTE study as per LATTE protocol dosing requirements and until Day 1 of the POLAR study. Any disruptions in dosing during LATTE must be discussed with the Medical Monitor for a final determination of eligibility.
Plasma HIV-1 RNA <50 c/mL at Week 300. If participant has plasma HIV-1 RNA >= 50 c/mL at Week 300 in LATTE, a single repeat to determine eligibility may be allowed ONLY after consultation with the medical monitor.

Exclusion Criteria:

During the last 6 months of participation in LATTE, consecutive (2 or more sequential) plasma HIV-1 RNA measurements >=50 c/mL.
During the last 6 months of participation in LATTE, any HIV-1 RNA measurement >=200 c/mL.
Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy.
Participants with moderate to severe hepatic impairment determined by Child-Pugh classification.
Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low.
Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
Participants has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows; Participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted, following consultation with the medical monitor).
Participants with HCV co-infection will be allowed entry into this study if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced.
Additional information (where available) on participants, with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis- 4 (Fib-4) score will be used to verify eligibility where Fib-4 score >3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation where the Fibrosis 4 Score Formula: age multiplied by aspartate amino transferase (AST) divided by platelets multiplied by square of alanine aminotransferase (ALT).
Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
History of liver cirrhosis with or without hepatitis viral co-infection.
Ongoing or clinically relevant pancreatitis.
Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization.
Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant 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 pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
Corrected QT interval (QTc (Bazett)) >450 millisecond (msec) or QTc (Bazett) >480 msec for participants with bundle branch block.
Any verified Grade 4 laboratory abnormality over the last 6 months in LATTE. A single repeat test is allowed to verify a result.
Any acute laboratory abnormality over the last 6 months in LATTE, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
ALT>=5 times upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5 times ULN (with >35 percent [%] direct bilirubin) over the last 6 months in LATTE.
Exposure to an experimental drug (with the exception of those in the LATTE study including CAB and RPV) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.
Treatment with any of the following agents within 28 days of Day 1: radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]); anti-coagulation agents.
Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility.
Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Phoenix	Arizona	United States	85015
2	GSK Investigational Site	Bakersfield	California	United States	93301
3	GSK Investigational Site	Beverly Hills	California	United States	90211
4	GSK Investigational Site	Long Beach	California	United States	90813
5	GSK Investigational Site	Los Angeles	California	United States	90069
6	GSK Investigational Site	Denver	Colorado	United States	80209
7	GSK Investigational Site	Washington	District of Columbia	United States	20007
8	GSK Investigational Site	Washington	District of Columbia	United States	20037
9	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
10	GSK Investigational Site	Fort Pierce	Florida	United States	34982
11	GSK Investigational Site	Orlando	Florida	United States	32803
12	GSK Investigational Site	West Palm Beach	Florida	United States	33407
13	GSK Investigational Site	Augusta	Georgia	United States	30912-3130
14	GSK Investigational Site	Macon	Georgia	United States	31201
15	GSK Investigational Site	Savannah	Georgia	United States	31401
16	GSK Investigational Site	Indianapolis	Indiana	United States	46202
17	GSK Investigational Site	Omaha	Nebraska	United States	68198
18	GSK Investigational Site	Las Vegas	Nevada	United States	89106
19	GSK Investigational Site	Buffalo	New York	United States	14215
20	GSK Investigational Site	New York	New York	United States	10032
21	GSK Investigational Site	New York	New York	United States	10065
22	GSK Investigational Site	Charleston	South Carolina	United States	29425
23	GSK Investigational Site	Austin	Texas	United States	78705
24	GSK Investigational Site	Dallas	Texas	United States	75246
25	GSK Investigational Site	Annandale	Virginia	United States	22003
26	GSK Investigational Site	Vancouver	British Columbia	Canada	V6Z 2T1
27	GSK Investigational Site	Toronto	Ontario	Canada	M4N 3M5
28	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1K2
29	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4E9
30	GSK Investigational Site	Montreal	Quebec	Canada	H3A 1T1

Sponsors and Collaborators

ViiV Healthcare
Janssen, LP

Investigators

Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT03639311

Other Study ID Numbers:

209035

First Posted:

Aug 21, 2018

Last Update Posted:

Jul 6, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ViiV Healthcare

HIV

Antiretroviral therapy

Maintenance

Long acting

LATTE

Additional relevant MeSH terms:

HIV Infections

Study Results

Participant Flow

Recruitment Details	This was a multicenter, open-label, rollover study evaluating the efficacy, safety and tolerability of long acting (LA) cabotegravir (CAB) plus LA rilpivirine (RPV) administered every 2 months (Q2M) in human immunodeficiency virus-1 (HIV-1) adult participants who were virologically suppressed and participated in study LAI116482 (NCT01641809).
Pre-assignment Detail	A total of 97 participants were enrolled in the study. The results presented are based on the Month 12 primary analysis. Data collection is still on-going and additional results will be provided after study completion analysis.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Period Title: Overall Study
STARTED	90	7
COMPLETED	0	7
NOT COMPLETED	90	0

Baseline Characteristics

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV	Total
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.	Total of all reporting groups
Overall Participants	90	7	97
Age (Years) [Mean (Standard Deviation) ]
Overall Study	41.2 (9.49)	49.1 (11.42)	41.7 (9.80)
Sex: Female, Male (Count of Participants)
Female	2 2.2%	0 0%	2 2.1%
Male	88 97.8%	7 100%	95 97.9%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 1.1%	0 0%	1 1%
Asian-Japanese/East Asian/South East Asian Heritage	1 1.1%	0 0%	1 1%
Black or African American	21 23.3%	3 42.9%	24 24.7%
White	63 70%	4 57.1%	67 69.1%
Multiple	4 4.4%	0 0%	4 4.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12
Description	Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Number (95% Confidence Interval) [Percentage of participants]	0 0%	0 0%

2. Secondary Outcome

Title	Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12
Description	Percentage of participants with HIV-1 RNA <50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Number (95% Confidence Interval) [Percentage of participants]	98 108.9%	100 1428.6%

3. Secondary Outcome

Title	Percentage of Participants With Protocol-defined Confirmed Virologic Failure Overtime
Description	Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Number [Percentage of participants]	0 0%	0 0%

4. Secondary Outcome

Title	Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm
Description	Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Baseline (Day 1)	0 0%
Month 2	0 0%
Month 4	1 1.1%
Month 6	0 0%
Month 8	0 0%
Month 10	0 0%
Month 12	0 0%

5. Secondary Outcome

Title	Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV
Description	Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Baseline (Day 1)	0.0 0%
Month 3	0.0 0%
Month 6	0.0 0%
Month 9	0.0 0%
Month 12	0.0 0%

6. Secondary Outcome

Title	Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Baseline (Day 1), n=89	1.591 (0.0085)
Month 2, n=90	1.590 (0.0000)
Month 4, n=89	1.594 (0.0305)
Month 6, n=89	1.590 (0.0042)
Month 8, n=89	1.590 (0.0000)
Month 10, n=88	1.594 (0.0384)
Month 12, n=88	1.590 (0.0000)

7. Secondary Outcome

Title	Absolute Values for HIV-1 RNA of DTG + RPV Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
ITT-E Population.

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Baseline (Day 1)	1.590 (0.0000)
Month 3	1.590 (0.0000)
Month 6	1.590 (0.0000)
Month 9	1.590 (0.0000)
Month 12	1.590 (0.0000)

8. Secondary Outcome

Title	Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=89	-0.001 (0.0085)
Month 4, n=88	0.003 (0.0299)
Month 6, n=88	-0.000 (0.0096)
Month 8, n=88	-0.001 (0.0085)
Month 10, n=87	0.003 (0.0396)
Month 12, n=87	-0.001 (0.0086)

9. Secondary Outcome

Title	Change From Baseline in HIV-1 RNA for DTG + RPV Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	0.000 (0.0000)
Month 6	0.000 (0.0000)
Month 9	0.000 (0.0000)
Month 12	0.000 (0.0000)

10. Secondary Outcome

Title	Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Baseline (Day 1), n=90	873.0 (233.37)
Month 2, n= 90	868.1 (261.49)
Month 4, n= 88	879.8 (280.88)
Month 6, n= 5	1046.8 (435.74)
Month 8, n= 88	857 (277.46)
Month 12, n= 88	859.2 (283.23)

11. Secondary Outcome

Title	Absolute Values for CD4+ for DTG + RPV Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Baseline (Day 1)	804.3 (167.73)
Month 3	780.3 (145.22)
Month 6	728.9 (147.06)
Month 9	777.0 (251.37)
Month 12	790.4 (141.80)

12. Secondary Outcome

Title	Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n= 90	-4.9 (196.47)
Month 4, n= 88	5.3 (221.68)
Month 6, n= 5	100.2 (343.66)
Month 8, n= 88	-20.7 (218.39)
Month 12, n= 88	-19.4 (189.19)

13. Secondary Outcome

Title	Change From Baseline Values for CD4+ for DTG + RPV Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-24.0 (118.40)
Month 6	-75.4 (123.71)
Month 9	-27.3 (150.96)
Month 12	-13.9 (145.76)

14. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs)
Description	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
Time Frame	Up to Month 17

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Non-SAE (>=5%)	76 84.4%	3 42.9%
SAE	5 5.6%	0 0%

15. Secondary Outcome

Title	Number of Participants With Severity of Adverse Events
Description	Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time Frame	Up to Month 17

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Grade 1	33 36.7%	0 0%
Grade 2	44 48.9%	3 42.9%
Grade 3	6 6.7%	0 0%
Grade 4	3 3.3%	0 0%
Grade 5	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Chemistry Toxicities
Description	Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
ALT, Grade 1	8 8.9%	1 14.3%
ALT, Grade 2	4 4.4%	0 0%
ALT, Grade 3	1 1.1%	0 0%
ALT, Grade 4	0 0%	0 0%
AST, Grade 1	8 8.9%	0 0%
AST, Grade 2	3 3.3%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	0 0%	0 0%
Bilirubin, Grade 1	2 2.2%	0 0%
Bilirubin, Grade 2	1 1.1%	0 0%
Bilirubin, Grade 3	0 0%	0 0%
Bilirubin, Grade 4	0 0%	0 0%
CO2, Grade 1	8 8.9%	1 14.3%
CO2, Grade 2	0 0%	0 0%
CO2, Grade 3	0 0%	0 0%
CO2, Grade 4	0 0%	0 0%
Cholesterol, Grade 1	6 6.7%	0 0%
Cholesterol, Grade 2	4 4.4%	0 0%
Cholesterol, Grade 3	0 0%	0 0%
Cholesterol, Grade 4	0 0%	0 0%
Creatine kinase, Grade 1	5 5.6%	0 0%
Creatine kinase, Grade 2	2 2.2%	0 0%
Creatine kinase, Grade 3	4 4.4%	0 0%
Creatine kinase, Grade 4	2 2.2%	0 0%
Creatinine, Grade 1	1 1.1%	0 0%
Creatinine, Grade 2	0 0%	0 0%
Creatinine, Grade 3	0 0%	0 0%
Creatinine, Grade 4	0 0%	0 0%
Direct bilirubin, Grade 1	0 0%	0 0%
Direct bilirubin, Grade 2	0 0%	0 0%
Direct bilirubin, Grade 3	1 1.1%	0 0%
Direct bilirubin, Grade 4	0 0%	0 0%
GFR from creatinine adjusted using CKD-EPI, Grade 1	0 0%	0 0%
GFR from creatinine adjusted using CKD-EPI, Grade 2	12 13.3%	5 71.4%
GFR from creatinine adjusted using CKD-EPI, Grade 3	1 1.1%	1 14.3%
GFR from creatinine adjusted using CKD-EPI, Grade 4	0 0%	0 0%
GFR from creatinine adjusted for BSA, Grade 1	0 0%	0 0%
GFR from creatinine adjusted for BSA, Grade 2	12 13.3%	5 71.4%
GFR from creatinine adjusted for BSA, Grade 3	1 1.1%	1 14.3%
GFR from creatinine adjusted for BSA, Grade 4	0 0%	0 0%
Glucose, Grade 1	13 14.4%	1 14.3%
Glucose, Grade 2	12 13.3%	0 0%
Glucose, Grade 3	0 0%	0 0%
Glucose, Grade 4	0 0%	0 0%
LDL cholesterol calculation, Grade 1	6 6.7%	0 0%
LDL cholesterol calculation, Grade 2	3 3.3%	0 0%
LDL cholesterol calculation, Grade 3	0 0%	0 0%
LDL cholesterol calculation, Grade 4	0 0%	0 0%
Lipase, Grade 1	6 6.7%	0 0%
Lipase, Grade 2	5 5.6%	2 28.6%
Lipase, Grade 3	2 2.2%	0 0%
Lipase, Grade 4	1 1.1%	0 0%
Phosphate, Grade 1	6 6.7%	0 0%
Phosphate, Grade 2	1 1.1%	0 0%
Phosphate, Grade 3	0 0%	0 0%
Phosphate, Grade 4	0 0%	0 0%
Sodium, Grade 1	4 4.4%	0 0%
Sodium, Grade 2	0 0%	0 0%
Sodium, Grade 3	0 0%	0 0%
Sodium, Grade 4	0 0%	0 0%
Triglycerides, Grade 1	5 5.6%	0 0%
Triglycerides, Grade 2	4 4.4%	0 0%
Triglycerides, Grade 3	1 1.1%	0 0%
Triglycerides, Grade 4	1 1.1%	0 0%

17. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Hematology Toxicities
Description	The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description
Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Platelets, Grade 1	2 2.2%	0 0%
Platelets, Grade 2	0 0%	0 0%
Platelets, Grade 3	0 0%	0 0%
Platelets, Grade 4	0 0%	0 0%

18. Secondary Outcome

Title	Percentage of Participants Who Permanently Discontinued Treatment Due to Adverse Events
Description	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to permanent withdrawal has been presented.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Number [Percentage of participants]	1 1.1%	0 0%

19. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
ALT, Month 2, n=90	-1.1 (16.99)
ALT, Month 4, n=89	-1.0 (26.15)
ALT, Month 8, n=89	0.0 (29.86)
ALT, Month 12, n=88	4.0 (44.62)
ALP, Month 2, n=90	0.2 (8.29)
ALP, Month 4, n=89	0.2 (14.20)
ALP, Month 8, n=89	2.0 (11.58)
ALP, Month 12, n=88	2.1 (12.39)
AST, Month 2, n=90	-5.6 (47.9)
AST, Month 4, n=89	-5.0 (50.5)
AST, Month 8, n=89	-5.3 (49.56)
AST, Month 12, n=88	-2.7 (54.93)
Creatine kinase, Month 2, n=90	-255.2 (2327.32)
Creatine kinase, Month 4, n=89	-204.0 (2483.41)
Creatine kinase, Month 8, n=89	-237.0 (2362.99)
Creatine kinase, Month 12, n=88	-252.0 (2429.86)

20. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
ALT, Month 3	-0.7 (22.37)
ALT, Month 6	-4.3 (19.99)
ALT, Month 9	1.7 (8.16)
ALT, Month 12	-0.3 (32.32)
ALP, Month 3	1.4 (10.11)
ALP, Month 6	1.6 (8.04)
ALP, Month 9	-1.1 (11.74)
ALP, Month 12	10.0 (33.16)
AST, Month 3	-0.6 (10.61)
AST, Month 6	-3.3 (7.30)
AST, Month 9	-1.4 (6.68)
AST, Month 12	-0.6 (14.68)
Creatine kinase, Month 3	-66.6 (287.66)
Creatine kinase, Month 6	-107.9 (112.18)
Creatine kinase, Month 9	-90.6 (163.40)
Creatine kinase, Month 12	-134.0 (149.59)

21. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=90	-0.8 (2.31)
Month 4, n=89	-0.9 (2.46)
Month 8, n=89	-0.8 (2.63)
Month 12, n=88	-0.9 (2.67)

22. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for DTG+ RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-1.6 (3.87)
Month 6	-1.4 (2.30)
Month 9	-1.3 (2.63)
Month 12	-2.6 (2.37)

23. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Bilirubin, Month 2, n=90	-1.0 (4.33)
Bilirubin, Month 4, n=89	-1.0 (5.14)
Bilirubin, Month 8, n=89	-1.0 (4.83)
Bilirubin, Month 12, n=88	-0.5 (4.35)
Creatinine, Month 2, n=90	-1.84 (7.121)
Creatinine, Month 4, n=89	-1.70 (9.393)
Creatinine, Month 8, n=89	-0.98 (7.977)
Creatinine, Month 12, n=88	-1.14 (9.204)

24. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for DTG+ RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

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

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Bilirubin, Month 3, n=7	-1.7 (4.23)
Bilirubin, Month 6, n=7	-1.4 (3.21)
Bilirubin, Month 9, n=7	-0.9 (2.54)
Bilirubin, Month 12, n=7	-1.4 (3.78)
Creatinine, Month 3, n=7	11.89 (8.89)
Creatinine, Month 6, n=7	8.36 (4.419)
Creatinine, Month 9, n=7	16.56 (10.131)
Creatinine, Month 12, n=7	7.47 (7.328)

25. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Carbon dioxide, Month 2, n=90	-0.4 (1.86)
Carbon dioxide, Month 4, n=89	-0.1 (2.00)
Carbon dioxide, Month 8, n=89	-0.2 (2.22)
Carbon dioxide, Month 12, n=88	-0.7 (2.18)
Chloride, Month 2, n=90	1.0 (2.06)
Chloride, Month 4, n=89	1.1 (2.20)
Chloride, Month 8, n=89	1.2 (2.07)
Chloride, Month 12, n=88	1.0 (2.24)
Glucose, Month 2, n=64	0.32 (0.568)
Glucose, Month 4, n=62	0.42 (0.684)
Glucose, Month 8, n=62	0.47 (0.842)
Glucose, Month 12, n=87	0.32 (0.662)
Phosphate, Month 2, n=90	-0.00 (0.176)
Phosphate, Month 4, n=89	-0.00 (0.191)
Phosphate, Month 8, n=89	-0.02 (0.206)
Phosphate, Month 12, n=88	-0.02 (0.199)
Potassium, Month 2, n=90	0.06 (0.392)
Potassium, Month 4, n=89	-0.02 (0.450)
Potassium, Month 8, n=89	0.05 (0.408)
Potassium, Month 12, n=88	0.06 (0.375)
Sodium, Month 2, n=90	0.2 (1.84)
Sodium, Month 4, n=89	0.6 (2.10)
Sodium, Month 8, n=89	0.6 (1.96)
Sodium, Month 12, n=88	0.2 (1.88)
Urea, Month 2, n=90	0.13 (1.253)
Urea, Month 4, n=89	-0.06 (1.346)
Urea, Month 8, n=89	0.28 (1.131)
Urea, Month 12, n=88	-0.11 (1.318)

26. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

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

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Carbon dioxide, Month 3, n=7	-1.0 (1.53)
Carbon dioxide, Month 6, n=7	-1.7 (1.50)
Carbon dioxide, Month 9, n=7	-1.9 (2.85)
Carbon dioxide, Month 12, n=7	-1.9 (2.48)
Chloride, Month 3, n=7	1.0 (1.83)
Chloride, Month 6, n=7	1.7 (2.14)
Chloride, Month 9, n=7	1.0 (0.82)
Chloride, Month 12, n=7	1.0 (2.08)
Glucose, Month 3, n=5	0.08 (0.259)
Glucose, Month 6, n=5	0.16 (0.483)
Glucose, Month 9, n=4	0.15 (0.700)
Glucose, Month 12, n=7	0.07 (0.55)
Phosphate, Month 3, n=7	0.02 (0.131)
Phosphate, Month 6, n=7	0.08 (0.177)
Phosphate, Month 9, n=7	0.05 (0.178)
Phosphate, Month 12, n=7	-0.05 (0.101)
Potassium, Month 3, n=7	-0.26 (0.378)
Potassium, Month 6, n=7	-0.03 (0.250)
Potassium, Month 9, n=7	0.01 (0.135)
Potassium, Month 12, n=7	-0.06 (0.257)
Sodium, Month 3, n=7	0.1 (1.68)
Sodium, Month 6, n=7	-0.9 (0.90)
Sodium, Month 9, n=7	-1.0 (2.58)
Sodium, Month 12, n=7	-1.1 (1.07)
Urea, Month 3, n=7	1.43 (0.732)
Urea, Month 6, n=7	1.14 (1.144)
Urea, Month 9, n=7	1.86 (1.994)
Urea, Month 12, n=7	0.71 (0.756)

27. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, LDL Cholesterol Direct and Triglycerides for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, direct HDL cholesterol, LDL cholesterol calculation, direct LDL cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Month 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Cholesterol, n=88	0.12 (0.760)
Direct HDL cholesterol, n=88	-0.05 (0.224)
LDL cholesterol calculation, n=83	0.10 (0.718)
Direct LDL cholesterol, n=2	0.21 (0.367)
Triglycerides, n=88	0.28 (1.965)

28. Secondary Outcome

Title	Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.
Time Frame	At Day 1

Outcome Measure Data

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

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Cholesterol, n=7	4.88 (1.352)
Direct HDL cholesterol, n=7	1.59 (0.258)
LDL cholesterol calculation, n=6	2.29 (0.52)
Direct LDL cholesterol, n=1	4.45 (NA)
Triglycerides, n=7	1.52 (1.493)

29. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=90	1.9 (7.70)
Month 4, n=89	1.7 (10.09)
Month 8, n=88	0.8 (8.63)
Month 12, n=88	0.3 (10.32)

30. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-11.7 (10.83)
Month 6	-7.4 (4.28)
Month 9	-16.6 (12.27)
Month 12	-7.3 (8.71)

31. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=90	0.03 (0.128)
Month 4, n=89	0.02 (0.168)
Month 8, n=88	0.01 (0.143)
Month 12, n=88	0.00 (0.172)

32. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-0.19 (0.180)
Month 6	-0.12 (0.071)
Month 9	-0.27 (0.204)
Month 12	-0.12 (0.145)

33. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=90	-0.1 (29.11)
Month 4, n=89	3.7 (47.68)
Month 8, n=89	-1.3 (29.43)
Month 12, n=88	-2.9 (36.83)

34. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	2.6 (6.90)
Month 6	4.4 (4.35)
Month 9	1.3 (6.85)
Month 12	26.0 (49.76)

35. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Month 12

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	88
Mean (Standard Deviation) [Ratio]	0.20 (1.698)

36. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Month 6

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	2
Mean (Standard Deviation) [Ratio]	0.55 (0.679)

37. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Basophils, Month 2, n=85	-0.000 (0.02200)
Basophils, Month 4, n=82	0.009 (0.02913)
Basophils, Month 8, n=86	0.003 (0.02524)
Basophils, Month 12, n=86	-0.003 (0.02501)
Eosinophils, Month 2, n=85	0.017 (0.11886)
Eosinophils, Month 4, n=82	0.004 (0.12341)
Eosinophils, Month 8, n=86	0.003 (0.14555)
Eosinophils, Month 12, n=86	-0.000 (0.13671)
Leukocytes, Month 2, n=85	-0.054 (1.1875)
Leukocytes, Month 4, n=82	0.276 (1.4416)
Leukocytes, Month 8, n=86	0.257 (1.4252)
Leukocytes, Month 12, n=86	-0.153 (1.1961)
Lymphocytes, Month 2, n=88	0.196 (0.49569)
Lymphocytes, Month 4, n=86	0.178 (0.52066)
Lymphocytes, Month 8, n=86	0.139 (0.50957)
Lymphocytes, Month 12, n=86	0.021 (0.60569)
Monocytes, Month 2, n=85	0.022 (0.11715)
Monocytes, Month 4, n=82	0.048 (0.14689)
Monocytes, Month 8, n=86	0.026 (0.16979)
Monocytes, Month 12, n=86	-0.021 (0.15241)
Neutrophils, Month 2, n=85	-0.197 (0.99349)
Neutrophils, Month 4, n=82	0.056 (1.19574)
Neutrophils, Month 8, n=86	0.120 (1.18605)
Neutrophils, Month 12, n=86	-0.134 (1.03311)
Platelets, Month 2, n=82	3.77 (23.389)
Platelets, Month 4, n=81	5.40 (30.889)
Platelets, Month 8, n=84	3.74 (24.695)
Platelets, Month 12, n=84	1.14 (32.005)

38. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Basophils, Month 3	-0.008 (0.01464)
Basophils, Month 6	-0.010 (0.02309)
Basophils, Month 9	-0.005 (0.01512)
Basophils, Month 12	-0.010 (0.01732)
Eosinophils, Month 3	-0.072 (0.16307)
Eosinophils, Month 6	-0.057 (0.11236)
Eosinophils, Month 9	-0.051 (0.10040)
Eosinophils, Month 12	-0.030 (0.17127)
Leukocytes, Month 3	0.014 (0.7669)
Leukocytes, Month 6	-0.386 (0.8355)
Leukocytes, Month 9	0.014 (1.3508)
Leukocytes, Month 12	-0.057 (0.9343)
Lymphocytes, Month 3	0.053 (0.43811)
Lymphocytes, Month 6	-0.019 (0.35435)
Lymphocytes, Month 9	0.085 (0.59379)
Lymphocytes, Month 12	-0.001 (0.39121)
Monocytes, Month 3	0.098 (0.08877)
Monocytes, Month 6	0.020 (0.07211)
Monocytes, Month 9	-0.021 (0.06644)
Monocytes, Month 12	0.004 (0.07435)
Neutrophils, Month 3	0.097 (0.47612)
Neutrophils, Month 6	-0.295 (0.64143)
Neutrophils, Month 9	0.115 (1.20803)
Neutrophils, Month 12	-0.034 (0.80715)
Platelets, Month 3	-1.00 (18.841)
Platelets, Month 6	-12.57 (35.298)
Platelets, Month 9	-21.29 (61.372)
Platelets, Month 12	-2.86 (47.544)

39. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=85	-1.07 (1.731)
Month 4, n=82	-2.04 (2.186)
Month 8, n=86	-1.42 (2.527)
Month 12, n=86	-1.28 (2.528)

40. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-1.00 (1.000)
Month 6	0.14 (1.574)
Month 9	0.29 (1.704)
Month 12	-0.14 (1.952)

41. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=85	-0.064 (0.2773)
Month 4, n=82	-0.021 (0.3185)
Month 8, n=86	-0.085 (0.3164)
Month 12, n=86	-0.063 (0.3279)

42. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-0.114 (0.1464)
Month 6	-0.171 (0.1113)
Month 9	-0.171 (0.1704)
Month 12	-0.143 (0.0976)

43. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=85	-0.011 (0.02762)
Month 4, n=82	-0.012 (0.02935)
Month 8, n=86	-0.015 (0.02809)
Month 12, n=86	-0.011 (0.02760)

44. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-0.015 (0.01516)
Month 6	-0.013 (0.01287)
Month 9	-0.013 (0.01332)
Month 12	-0.013 (0.01491)

45. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Measure Participants	90
Month 2, n=85	-2.11 (8.801)
Month 4, n=82	-1.57 (9.433)
Month 8, n=86	-3.29 (8.542)
Month 12, n=86	-3.19 (8.814)

46. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	7
Month 3	-3.57 (6.554)
Month 6	-4.29 (2.928)
Month 9	-4.86 (3.891)
Month 12	-4.57 (5.062)

47. Secondary Outcome

Title	Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio
Description	Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.
Time Frame	At Day 1

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Urine albumin/creatinine ratio, n=68, 5	0.7 (0.980)	0.4 (0.122)
Urine protein/creatinine ratio, n=73, 5	7.6 (4.528)	9.1 (7.237)

48. Secondary Outcome

Title	Absolute Values of Urine Creatinine
Description	Urine samples were collected for the analysis of urine creatinine.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description
Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Mean (Standard Deviation) [Micromoles per liter]	14875.6 (9267.95)	12112.9 (7186.16)

49. Secondary Outcome

Title	Absolute Values of Urine Phosphate
Description	Urine samples were collected for the analysis of urine phosphate.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description
Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Mean (Standard Deviation) [Millimoles per liter]	18.2 (15.306)	14.7 (6.917)

50. Secondary Outcome

Title	Absolute Values of Urine Specific Gravity
Description	Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at specified time points has been presented.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	89	7
Mean (Standard Deviation) [Ratio]	1.0 (0.007)	1.0 (0.007)

51. Secondary Outcome

Title	Absolute Values of Urine Potential of Hydrogen (pH)
Description	Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at specified time points has been presented.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	89	7
Mean (Standard Deviation) [pH]	6.1 (0.739)	6.5 (0.345)

52. Secondary Outcome

Title	Number of Participants With Treatment Emergent Genotypic Resistance
Description	Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants reporting confirmed virologic failure were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	0	0

53. Secondary Outcome

Title	Number of Participants With Treatment Emergent Phenotypic Resistance
Description	Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants reporting confirmed virologic failure were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	0	0

54. Other Pre-specified Outcome

Title	Plasma Trough Concentration (Ctrough) for CAB LA
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted.
Time Frame	Pre-dose (Day 1) and Month 12

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population

Arm/Group Title	CAB LA
Arm/Group Description	Participants in this arm received their first dose CAB LA (600 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (CAB LA 600 mg) occurring Q2M thereafter.
Measure Participants	0

55. Other Pre-specified Outcome

Title	Ctrough for RPV LA
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted.
Time Frame	Pre-dose (Day 1) and Month 12

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population

Arm/Group Title	RPV LA
Arm/Group Description	Participants in this arm received their first dose RPV LA (900 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (RPV LA 900 mg) occurring Q2M thereafter.
Measure Participants	0

56. Secondary Outcome

Title	Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV)
Description	HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted impact score was calculated for 26 individual domain items by multiplying impact score (-3[maximum negative impact] to +1[maximum positive impact] by the corresponding importance score (3 [very important] to 0[not all important]). Average Weighted impact (AWI) score was calculated by summing individual weighted impact scores and dividing by the number of domain items. The ranges of weighted impact score and average impact score were from -9(maximum negative impact) to +3(maximum positive impact); higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value).
Time Frame	Baseline (Day 1) and at Months 6 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Overview Item 1, Month 6, n=89, 7	0.1 (0.65)	0.4 (0.53)
Overview Item 1, Month 12, n=88, 7	0.0 (0.75)	-0.1 (0.38)
Overview Item 2, Month 6, n=89, 7	0.0 (1.11)	0.3 (1.25)
Overview Item 2, Month 12, n=88, 7	0.2 (1.05)	-0.6 (1.13)
Leisure, Month 6, n=89, 7	0.1 (2.20)	0.9 (1.46)
Leisure, Month 12, n=87, 7	0.2 (2.02)	-1.6 (3.74)
Work, Month 6, n=86, 7	-0.3 (2.07)	-0.9 (4.14)
Work, Month 12, n=84, 7	-0.1 (2.48)	-0.7 (2.75)
Holiday, Month 6, n=84, 7	-0.5 (2.24)	-0.3 (3.55)
Holiday, Month 12, n=84, 5	-0.1 (2.76)	-2.0 (2.83)
Getting out and about, Month 6, n=89, 7	0.0 (1.83)	-1.1 (3.76)
Getting out and about, Month 12, n=88, 7	-0.2 (2.01)	-1.9 (2.48)
Long journey, Month 6, n=89, 7	0.3 (2.24)	-0.4 (2.70)
Long journey, Month 12, n=88, 7	0.4 (2.45)	-2.3 (2.93)
Do Physically, Month 6, n=89, 7	-0.2 (2.09)	-0.7 (2.36)
Do Physically, Month 12, n=88, 7	-0.3 (2.39)	-1.7 (2.63)
Family, Month 6, n=83, 7	-0.1 (1.38)	-0.9 (2.27)
Family, Month 12, n=82, 6	-0.3 (2.30)	-1.5 (2.51)
Friends, Month 6, n=89, 7	-0.7 (1.93)	-1.1 (2.85)
Friends, Month 12, n=88, 7	-0.3 (2.57)	-2.0 (2.38)
Go on dates, Month 6, n=62, 2	-0.4 (2.04)	-3.5 (3.54)
Go on dates, Month 12, n=60, 2	-0.2 (3.11)	-3.5 (3.54)
Close relationships, Month 6, n=71, 6	0.4 (3.10)	-0.5 (2.95)
Close relationships, Month 12, n=68, 6	0.2 (3.13)	-0.5 (2.95)
Sex life, Month 6, n=80, 6	0.2 (2.74)	-1.3 (2.80)
Sex life, Month 12, n=80, 5	-0.2 (2.62)	-1.0 (3.00)
Physical appearance, Month 6, n=89, 7	-0.3 (1.78)	-1.1 (2.85)
Physical appearance, Month 12, n=88, 7	-0.2 (2.28)	-1.4 (2.23)
Self-confidence, Month 6, n=88, 7	0.0 (2.35)	-1.7 (2.43)
Self-confidence, Month 12, n=86, 7	0.2 (2.83)	-2.9 (3.48)
Motivation, Month 6, n=89, 7	-0.3 (2.04)	-0.6 (2.51)
Motivation, Month 12, n=86, 7	-0.3 (2.85)	-2.1 (2.85)
Stigma, Month 6, n=40, 0	-1.1 (2.38)
Stigma, Month 12, n=38, 1	0.0 (3.03)	-2.0 (NA)
Conceal, Month 6, n=55, 5	-0.6 (2.91)	-1.6 (3.51)
Conceal, Month 12, n=55, 5	0.3 (3.04)	-0.4 (4.10)
Feelings About the Future, Month 6, n=89, 7	0.0 (2.89)	1.0 (2.24)
Feelings About the Future, Month 12, n=87, 7	0.3 (3.02)	-0.9 (2.85)
Financial Situation, Month 6, n=89, 7	-0.1 (2.76)	1.1 (1.46)
Financial Situation, Month 12, n=88, 7	-0.1 (2.59)	-0.6 (4.61)
Depend on Others, Month 6, n=37, 4	-0.4 (3.11)	0.0 (0.00)
Depend on Others, Month 12, n=35, 6	-0.2 (2.73)	-1.2 (3.25)
Others Fuss or Worry, Month 6, n=42, 5	0.0 (3.00)	-1.6 (3.36)
Others Fuss or Worry, Month 12, n=35, 6	0.1 (3.21)	-0.3 (3.50)
Freedom to Eat, Month 6, n=89, 7	0.0 (1.98)	-1.3 (3.40)
Freedom to Eat, Month 12, n=88, 7	0.1 (2.62)	-1.1 (2.48)
Freedom to Drink, Month 6, n=88, 7	-0.2 (1.81)	-0.7 (4.42)
Freedom to Drink, Month 12, n=87, 7	-0.1 (2.47)	-1.7 (3.40)
Spiritual/Religious Life, Month 6, n=46, 6	-0.1 (2.46)	-0.5 (1.22)
Spiritual/Religious Life, Month 12, n=45, 6	-0.1 (1.14)	-1.0 (2.45)
Feelings About the Past, Month 6, n=88, 7	-0.3 (2.69)	0.7 (2.21)
Feelings About the Past, Month 12, n=87, 7	0.0 (2.74)	-1.3 (2.21)
Having Children or More Children, Month 6, n=30, 4	0.3 (1.86)	1.3 (4.27)
Having Children or More Children, Month 12,n=35, 4	-0.3 (2.82)	-1.5 (3.00)
Sleep, Month 6, n=87, 7	-0.2 (2.32)	0.7 (1.25)
Sleep, Month 12, n=87, 7	0.0 (2.56)	-0.4 (2.70)
Average Weighted Impact, Month 6, n=89, 7	-0.17 (1.084)	-0.43 (1.792)
Average Weighted Impact, Month 12, n=88, 7	-0.07 (1.690)	-1.27 (1.695)

57. Secondary Outcome

Title	Change From Baseline in Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
Description	HIVTSQs total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 6 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Month 6, n=89, 7	-0.19 (6.419)	0.71 (3.773)
Month 12, n=88, 7	-0.42 (6.659)	0.14 (6.256)

58. Secondary Outcome

Title	Change From Baseline in Individual Item Score of HIVTSQs
Description	HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 6 and 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	90	7
Item 1, Month 6, n=89, 7	-0.1 (0.82)	0.0 (0.00)
Item 1, Month 12, n=88, 7	-0.1 (0.75)	-0.1 (0.38)
Item 2, Month 6, n=89, 7	-0.1 (0.46)	-0.3 (0.49)
Item 2, Month 12, n=88, 7	0.0 (0.34)	-0.1 (0.38)
Item 3, Month 6, n=89, 7	-0.5 (1.41)	0.1 (0.38)
Item 3, Month 12, n=88, 7	-0.5 (1.21)	-0.1 (0.38)
Item 4, Month 6, n=89, 7	0.0 (0.95)	0.0 (0.00)
Item 4, Month 12, n=88, 7	0.1 (0.93)	0.1 (0.69)
Item 5, Month 6, n=89, 7	0.1 (1.00)	0.3 (0.49)
Item 5, Month 12, n=87, 7	0.1 (1.14)	0.1 (0.38)
Item 6, Month 6, n=88, 7	0.1 (1.13)	0.4 (1.62)
Item 6, Month 12, n=88, 7	0.0 (1.31)	0.3 (1.80)
Item 7, Month 6, n=89, 7	0.1 (0.74)	0.0 (0.58)
Item 7, Month 12, n=88, 7	0.0 (1.06)	0.1 (0.69)
Item 8, Month 6, n=89, 7	0.2 (0.93)	0.0 (0.58)
Item 8, Month 12, n=88, 7	0.1 (0.95)	0.0 (0.58)
Item 9, Month 6, n=89, 7	-0.1 (0.61)	0.0 (0.00)
Item 9, Month 12, n=88, 7	-0.2 (0.80)	-0.1 (0.38)
Item 10, Month 6, n=89, 7	0.1 (0.91)	0.3 (0.76)
Item 10, Month 12, n=88, 7	0.1 (1.03)	0.1 (0.90)
Item 11, Month 6, n=89, 7	0.0 (1.09)	-0.1 (0.38)
Item 11, Month 12, n=88, 7	0.1 (0.79)	-0.1 (0.90)
Item 12, Month 6, n=89, 7	-1.3 (1.59)	-0.6 (1.13)
Item 12, Month 12, n=88, 7	-1.1 (1.58)	-0.1 (0.38)

59. Secondary Outcome

Title	Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)
Description	HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and remain missing.
Time Frame	At Month 12

Outcome Measure Data

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

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Measure Participants	88	7
Mean (Standard Deviation) [Scores on a scale]	28.0 (6.78)	27.7 (6.97)

Adverse Events

	CAB LA + RPV LA Q2M		DTG + RPV
Time Frame	Non-SAEs and SAEs were collected from Day 1 and up to Month 17
Adverse Event Reporting Description	Non-SAEs and SAEs were collected in Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M		DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/7 (0%)
Serious Adverse Events
	CAB LA + RPV LA Q2M		DTG + RPV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/90 (5.6%)		0/7 (0%)
Gastrointestinal disorders
Proctitis	1/90 (1.1%)	1	0/7 (0%)	0
General disorders
Injection site extravasation	1/90 (1.1%)	1	0/7 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	1/90 (1.1%)	1	0/7 (0%)	0
Cholelithiasis	1/90 (1.1%)	1	0/7 (0%)	0
Infections and infestations
Anal abscess	1/90 (1.1%)	1	0/7 (0%)	0
Orchitis	1/90 (1.1%)	1	0/7 (0%)	0
Urinary tract infection bacterial	1/90 (1.1%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	CAB LA + RPV LA Q2M		DTG + RPV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	76/90 (84.4%)		3/7 (42.9%)
Gastrointestinal disorders
Diarrhoea	9/90 (10%)	13	0/7 (0%)	0
Haemorrhoids	5/90 (5.6%)	5	0/7 (0%)	0
Nausea	5/90 (5.6%)	5	0/7 (0%)	0
Abdominal pain	2/90 (2.2%)	3	1/7 (14.3%)	1
General disorders
Injection site pain	67/90 (74.4%)	414	0/7 (0%)	0
Injection site discomfort	10/90 (11.1%)	20	0/7 (0%)	0
Pyrexia	9/90 (10%)	20	0/7 (0%)	0
Fatigue	6/90 (6.7%)	16	0/7 (0%)	0
Injection site nodule	5/90 (5.6%)	6	0/7 (0%)	0
Injection site swelling	5/90 (5.6%)	11	0/7 (0%)	0
Hepatobiliary disorders
Hepatic steatosis	0/90 (0%)	0	1/7 (14.3%)	1
Infections and infestations
Nasopharyngitis	10/90 (11.1%)	10	0/7 (0%)	0
Upper respiratory tract infection	10/90 (11.1%)	11	0/7 (0%)	0
Syphilis	6/90 (6.7%)	6	0/7 (0%)	0
Injury, poisoning and procedural complications
Muscle strain	1/90 (1.1%)	1	1/7 (14.3%)	1
Nervous system disorders
Headache	6/90 (6.7%)	7	1/7 (14.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	5/90 (5.6%)	5	0/7 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	0/90 (0%)	0	1/7 (14.3%)	1

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.

Results Point of Contact

Name/Title	GSK Response Center
Organization	ViiV Healthcare
Phone	866-435-7343
Email	GSKClinicalSupportHD@gsk.com

Responsible Party:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT03639311

Other Study ID Numbers:

209035

First Posted:

Aug 21, 2018

Last Update Posted:

Jul 6, 2022

Last Verified:

Jul 1, 2022