Trial Outcomes & Findings for Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (NCT NCT02951052)

Last Updated: 2025-12-31

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

618 participants

Primary outcome timeframe

Week 48

Results posted on

2025-12-31

Participant Flow

This was a phase III, randomized, open-label, active-controlled, multi-center, parallel-group, non-inferiority study to evaluate the antiviral activity and safety of two long-acting (LA) injectable drugs, cabotegravir (CAB) plus rilpivirine (RPV) when compared to current standard of care conducted in virologically suppressed human immunodeficiency.

A total of 618 participants were enrolled in the study. Two randomized participants did not receive study treatment. A total of 616 participants contributed to the Intent-to-treat exposed Population and Safety Population. The results presented are based on Week 48 primary analysis.

Participant milestones

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 Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During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

Reasons for withdrawal

Reasons for withdrawal
Measure	CAB LA+RPV LA (Q4W) During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Study Adverse Event	13	5
Overall Study Withdrawal by Subject	1	5
Overall Study Physician Decision	2	0
Overall Study Lost to Follow-up	1	1
Overall Study Protocol-specified withdrawal criterion	1	0
Overall Study Protocol Violation	5	3
Overall Study Lack of Efficacy	3	4
Overall Study Ongoing	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA	Total n=616 Participants Total of all reporting groups
Age, Continuous	41.6 Years STANDARD_DEVIATION 9.99 • n=1000 Participants	43.2 Years STANDARD_DEVIATION 11.43 • n=1986 Participants	42.4 Years STANDARD_DEVIATION 10.76 • n=2008 Participants
Sex: Female, Male Female	99 Participants n=1000 Participants	104 Participants n=1986 Participants	203 Participants n=2008 Participants
Sex: Female, Male Male	209 Participants n=1000 Participants	204 Participants n=1986 Participants	413 Participants n=2008 Participants
Race/Ethnicity, Customized American Indian (AI) or Alaska Native (AN)	8 Participants n=1000 Participants	8 Participants n=1986 Participants	16 Participants n=2008 Participants
Race/Ethnicity, Customized Asian-Central South Asian Heritage	1 Participants n=1000 Participants	0 Participants n=1986 Participants	1 Participants n=2008 Participants
Race/Ethnicity, Customized Asian-Japanese/East/South-East Asian Heritage	21 Participants n=1000 Participants	13 Participants n=1986 Participants	34 Participants n=2008 Participants
Race/Ethnicity, Customized Black or African American	62 Participants n=1000 Participants	77 Participants n=1986 Participants	139 Participants n=2008 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=1000 Participants	1 Participants n=1986 Participants	1 Participants n=2008 Participants
Race/Ethnicity, Customized White	214 Participants n=1000 Participants	207 Participants n=1986 Participants	421 Participants n=2008 Participants
Race/Ethnicity, Customized AI or AN & Black/African American	0 Participants n=1000 Participants	1 Participants n=1986 Participants	1 Participants n=2008 Participants
Race/Ethnicity, Customized AI or AN & Black/African American & White	1 Participants n=1000 Participants	1 Participants n=1986 Participants	2 Participants n=2008 Participants
Race/Ethnicity, Customized Black/African American or White	1 Participants n=1000 Participants	0 Participants n=1986 Participants	1 Participants n=2008 Participants

PRIMARY outcome

Timeframe: Week 48

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48	285 Participants	294 Participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48	286 Participants	295 Participants

SECONDARY outcome

Timeframe: Weeks 8, 12, 20, 24, 32 and 40

Population: ITT-E Population

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=265 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=292 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Absolute Values for Plasma HIV-1 RNA at Week 48	1.505 log10 copies/mL Standard Deviation 0.0470	1.518 log10 copies/mL Standard Deviation 0.1123

SECONDARY outcome

Timeframe: Baseline and Week 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 48

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=263 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=290 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Absolute Values for CD4+ Lymphocyte Count at Week 48	685.3 Cells per cubic millimeter Standard Deviation 262.97	716.7 Cells per cubic millimeter Standard Deviation 292.85

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=263 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=290 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline Values for CD4+ Lymphocyte Count at Week 48	9.9 Cells per cubic millimeter Standard Deviation 187.24	19.4 Cells per cubic millimeter Standard Deviation 168.80

SECONDARY outcome

Timeframe: Up to Week 48

Population: ITT-E Population

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

Outcome measures

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

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

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

Outcome measures

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

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Absolute Values for Hematology Parameters: Erythrocytes Baseline, n=308, 308	4.55 10^12 cells per liter Standard Deviation 0.563	4.49 10^12 cells per liter Standard Deviation 0.570
Absolute Values for Hematology Parameters: Erythrocytes Week 4, n=300, 300	4.59 10^12 cells per liter Standard Deviation 0.503	4.45 10^12 cells per liter Standard Deviation 0.567
Absolute Values for Hematology Parameters: Erythrocytes Week 8, n=218, 301	4.68 10^12 cells per liter Standard Deviation 0.479	4.49 10^12 cells per liter Standard Deviation 0.566
Absolute Values for Hematology Parameters: Erythrocytes Week 12, n=294, 293	4.79 10^12 cells per liter Standard Deviation 0.464	4.51 10^12 cells per liter Standard Deviation 0.580
Absolute Values for Hematology Parameters: Erythrocytes Week 16, n=280, 296	4.84 10^12 cells per liter Standard Deviation 0.475	4.48 10^12 cells per liter Standard Deviation 0.549
Absolute Values for Hematology Parameters: Erythrocytes Week 20, n=276, 298	4.86 10^12 cells per liter Standard Deviation 0.459	4.48 10^12 cells per liter Standard Deviation 0.586
Absolute Values for Hematology Parameters: Erythrocytes Week 24, n=279, 294	4.86 10^12 cells per liter Standard Deviation 0.471	4.48 10^12 cells per liter Standard Deviation 0.572
Absolute Values for Hematology Parameters: Erythrocytes Week 28, n=268, 297	4.85 10^12 cells per liter Standard Deviation 0.456	4.47 10^12 cells per liter Standard Deviation 0.565
Absolute Values for Hematology Parameters: Erythrocytes Week 48, n=255, 284	4.81 10^12 cells per liter Standard Deviation 0.448	4.50 10^12 cells per liter Standard Deviation 0.600
Absolute Values for Hematology Parameters: Erythrocytes Week 44, n=273, 286	4.86 10^12 cells per liter Standard Deviation 0.448	4.49 10^12 cells per liter Standard Deviation 0.572
Absolute Values for Hematology Parameters: Erythrocytes Week 32, n=268, 291	4.84 10^12 cells per liter Standard Deviation 0.452	4.48 10^12 cells per liter Standard Deviation 0.550
Absolute Values for Hematology Parameters: Erythrocytes Week 36, n=267, 288	4.81 10^12 cells per liter Standard Deviation 0.462	4.49 10^12 cells per liter Standard Deviation 0.561
Absolute Values for Hematology Parameters: Erythrocytes Week 40, n=264, 289	4.84 10^12 cells per liter Standard Deviation 0.456	4.49 10^12 cells per liter Standard Deviation 0.572

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline for Hematology Parameters: Erythrocytes Week 20, n=276, 298	0.30 10^12 cells per liter Standard Deviation 0.408	-0.01 10^12 cells per liter Standard Deviation 0.273
Change From Baseline for Hematology Parameters: Erythrocytes Week 24, n=279, 294	0.32 10^12 cells per liter Standard Deviation 0.397	-0.01 10^12 cells per liter Standard Deviation 0.246
Change From Baseline for Hematology Parameters: Erythrocytes Week 28, n=268, 297	0.28 10^12 cells per liter Standard Deviation 0.386	-0.01 10^12 cells per liter Standard Deviation 0.246
Change From Baseline for Hematology Parameters: Erythrocytes Week 32, n=268, 291	0.29 10^12 cells per liter Standard Deviation 0.393	-0.01 10^12 cells per liter Standard Deviation 0.261
Change From Baseline for Hematology Parameters: Erythrocytes Week 36, n=267, 288	0.26 10^12 cells per liter Standard Deviation 0.401	-0.01 10^12 cells per liter Standard Deviation 0.259
Change From Baseline for Hematology Parameters: Erythrocytes Week 40, n=264, 289	0.27 10^12 cells per liter Standard Deviation 0.396	-0.01 10^12 cells per liter Standard Deviation 0.260
Change From Baseline for Hematology Parameters: Erythrocytes Week 44, n=273, 286	0.31 10^12 cells per liter Standard Deviation 0.391	-0.01 10^12 cells per liter Standard Deviation 0.264
Change From Baseline for Hematology Parameters: Erythrocytes Week 48, n=255, 284	0.25 10^12 cells per liter Standard Deviation 0.394	-0.01 10^12 cells per liter Standard Deviation 0.262
Change From Baseline for Hematology Parameters: Erythrocytes Week 4, n=300, 300	0.04 10^12 cells per liter Standard Deviation 0.255	-0.03 10^12 cells per liter Standard Deviation 0.226
Change From Baseline for Hematology Parameters: Erythrocytes Week 8, n=218, 301	0.14 10^12 cells per liter Standard Deviation 0.331	-0.01 10^12 cells per liter Standard Deviation 0.249
Change From Baseline for Hematology Parameters: Erythrocytes Week 12, n=294, 293	0.23 10^12 cells per liter Standard Deviation 0.374	0.01 10^12 cells per liter Standard Deviation 0.252
Change From Baseline for Hematology Parameters: Erythrocytes Week 16, n=280, 296	0.28 10^12 cells per liter Standard Deviation 0.380	-0.01 10^12 cells per liter Standard Deviation 0.256

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Baseline, n=308, 308	100.5 Milliliter per minute per 1.73meter^2 Standard Deviation 18.30	101.1 Milliliter per minute per 1.73meter^2 Standard Deviation 17.72
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 4, n=301, 301	98.7 Milliliter per minute per 1.73meter^2 Standard Deviation 17.26	98.9 Milliliter per minute per 1.73meter^2 Standard Deviation 17.93
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 8, n=227, 303	100.1 Milliliter per minute per 1.73meter^2 Standard Deviation 17.19	99.5 Milliliter per minute per 1.73meter^2 Standard Deviation 17.59
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 12, n=295, 297	100.9 Milliliter per minute per 1.73meter^2 Standard Deviation 17.72	99.2 Milliliter per minute per 1.73meter^2 Standard Deviation 18.34
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 16, n=284, 297	100.5 Milliliter per minute per 1.73meter^2 Standard Deviation 17.26	99.0 Milliliter per minute per 1.73meter^2 Standard Deviation 18.32
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 20, n=277, 302	99.4 Milliliter per minute per 1.73meter^2 Standard Deviation 17.37	98.7 Milliliter per minute per 1.73meter^2 Standard Deviation 17.73
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 24, n=283, 298	98.9 Milliliter per minute per 1.73meter^2 Standard Deviation 17.04	98.9 Milliliter per minute per 1.73meter^2 Standard Deviation 17.44
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 28, n=267, 296	98.5 Milliliter per minute per 1.73meter^2 Standard Deviation 17.66	99.0 Milliliter per minute per 1.73meter^2 Standard Deviation 17.33
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 32, n=274, 294	99.1 Milliliter per minute per 1.73meter^2 Standard Deviation 16.89	98.4 Milliliter per minute per 1.73meter^2 Standard Deviation 17.54
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 36, n=273, 292	99.0 Milliliter per minute per 1.73meter^2 Standard Deviation 17.19	98.6 Milliliter per minute per 1.73meter^2 Standard Deviation 16.85
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 40, n=268, 293	98.5 Milliliter per minute per 1.73meter^2 Standard Deviation 17.32	98.5 Milliliter per minute per 1.73meter^2 Standard Deviation 17.37
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 44, n=274, 293	98.2 Milliliter per minute per 1.73meter^2 Standard Deviation 16.96	99.0 Milliliter per minute per 1.73meter^2 Standard Deviation 17.39
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 48, n=264, 291	97.6 Milliliter per minute per 1.73meter^2 Standard Deviation 16.97	99.3 Milliliter per minute per 1.73meter^2 Standard Deviation 17.09

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48.

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin,Baseline (Day 1),Trace, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Baseline (Day 1), 1+, n=303, 301	6 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Baseline (Day 1), 2+, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Baseline (Day 1), 3+, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Baseline (Day 1), Trace, n=303, 301	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Baseline (Day 1), 1+, n=303, 301	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Baseline (Day 1), 2+, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Baseline (Day 1), 3+, n=303, 301	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Baseline (Day 1), Trace, n=303, 301	16 Participants	17 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Baseline (Day 1), 1+, n=303, 301	4 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Baseline (Day 1), 2+, n=303, 301	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Baseline (Day 1), 3+, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase,Baseline,Trace,n=303,301	25 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 24, 1+, n=279, 298	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 24, 2+, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 24, 3+, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Baseline, 1+, n=303, 301	14 Participants	16 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Baseline, 2+, n=303, 301	14 Participants	8 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Baseline, 3+, n=303, 301	5 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine nitrite, Baseline, positive, n=303, 301	11 Participants	11 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Baseline, Trace, n=303, 301	19 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase,Week 24, Trace, n=279,298	22 Participants	17 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Baseline, 1+, n=303, 301	8 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Baseline, 2+, n=303, 301	7 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Baseline, 3+, n=303, 301	5 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Baseline, Trace, n=303, 301	14 Participants	20 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Baseline, 1+, n=303, 301	6 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Baseline, 2+, n=303, 301	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Baseline, 3+, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Baseline, 4+, n=303, 301	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 4, Trace, n=303, 302	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 4, 1+, n=303, 302	9 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 4, 2+, n=303, 302	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 4, 3+, n=303, 302	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 4, Trace, n=303, 302	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 4, 1+, n=303, 302	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 4, 2+, n=303, 302	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 4, 3+, n=303, 302	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 4, Trace, n=303, 302	9 Participants	15 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 4, 1+, n=303, 302	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 4, 2+, n=303, 302	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 4, 3+, n=303, 302	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 4, Trace,n=303, 302	25 Participants	29 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 4, 1+, n=303, 302	14 Participants	15 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 4, 2+, n=303, 302	14 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 4, 3+, n=303, 302	3 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine nitrite, Week 4, positive, n=303, 302	10 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 4, Trace, n=303, 302	15 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 4, 1+, n=303, 302	9 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 4, 2+, n=303, 302	5 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 4, 3+, n=303, 302	4 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 4, Trace, n=303, 302	10 Participants	13 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 4, 1+, n=303, 302	8 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 4, 2+, n=303, 302	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 4, 3+, n=303, 302	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 4, 4+, n=303, 302	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 24, Trace, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 24, 1+, n=279, 298	10 Participants	13 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 24, 2+, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 24, 3+, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 24, Trace, n=279, 298	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 24, 1+, n=279, 298	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 24, 2+, n=279, 298	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 24, 3+, n=279, 298	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 24, Trace, n=279, 298	16 Participants	13 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 24, 1+, n=279, 298	14 Participants	14 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 24, 2+, n=279, 298	6 Participants	14 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 24, 3+, n=279, 298	3 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine nitrite, Week 24, positive, n=279, 298	9 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 24, Trace, n=279, 298	13 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 24, 1+, n=279, 298	5 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 24, 2+, n=279, 298	6 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 24, 3+, n=279, 298	0 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 24, Trace, n=279, 298	10 Participants	21 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 24, 1+, n=279, 298	4 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 24, 2+, n=279, 298	1 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 24, 3+, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 24, 4+, n=279, 298	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 48, Trace, n=279, 290	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 48, 1+, n=279, 290	9 Participants	8 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 48, 2+, n=279, 290	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine bilirubin, Week 48, 3+, n=279, 290	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 48, Trace, n=279, 290	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 48, 1+, n=279, 290	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 48, Trace, n=279, 290	11 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 48, 2+, n=279, 290	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine glucose, Week 48, 3+, n=279, 290	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 48, Trace, n=279, 290	13 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 48, 1+, n=279, 290	5 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 48, 2+, n=279, 290	4 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine occult blood, Week 48, 3+, n=279, 290	6 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 48, Trace, n=279, 290	10 Participants	15 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 48, 1+, n=279, 290	4 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 48, 2+, n=279, 290	3 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 48, 3+, n=279, 290	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine protein, Week 48, 4+, n=279, 290	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 48, 1+, n=279, 290	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 48, 2+, n=279, 290	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine ketones, Week 48, 3+, n=279, 290	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 48, Trace,n=279,290	24 Participants	27 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 48, 1+, n=279, 290	13 Participants	15 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 48, 2+, n=279, 290	7 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine leukocyte esterase, Week 48, 3+, n=279, 290	5 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48 Urine nitrite, Week 48, positive, n=279, 290	10 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=6.5, n=303, 301	47 Participants	45 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=6, n=303, 301	85 Participants	72 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=5, n=303, 301	44 Participants	42 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=5.5, n=303, 301	78 Participants	80 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=7, n=303, 301	32 Participants	34 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=7.5, n=303, 301	12 Participants	19 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=8, n=303, 301	3 Participants	7 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH=8.5, n=303, 301	0 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline, pH>9.0, n=303, 301	2 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=5, n=303, 302	41 Participants	53 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=5.5, n=303, 302	78 Participants	93 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=6, n=303, 302	73 Participants	67 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=6.5, n=303, 302	49 Participants	41 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=7, n=303, 302	38 Participants	28 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=7.5, n=303, 302	12 Participants	14 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=8, n=279, 298	7 Participants	8 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=6, n=279, 298	66 Participants	67 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=8, n=303, 302	8 Participants	3 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=8.5, n=303, 302	3 Participants	2 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH>9.0, n=303, 302	1 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=5, n=279, 298	23 Participants	26 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=5.5, n=279, 298	85 Participants	96 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=6.5, n=279, 298	44 Participants	52 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=7, n=279, 298	32 Participants	31 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=7.5, n=279, 298	16 Participants	15 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=8.5, n=279, 298	2 Participants	2 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH>9.0, n=279, 298	4 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=5, n=279, 290	45 Participants	43 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=5.5, n=279, 290	69 Participants	83 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=6, n=279, 290	61 Participants	58 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=6.5, n=279, 290	47 Participants	48 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=7, n=279, 290	31 Participants	30 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=7.5, n=279, 290	17 Participants	17 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=8, n=279, 290	6 Participants	5 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=8.5, n=279, 290	0 Participants	4 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH>9.0, n=279, 290	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 4, n=301, 301	-1.8 Milliliters per minute per 1.73meter^2 Standard Deviation 9.51	-2.3 Milliliters per minute per 1.73meter^2 Standard Deviation 9.18
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 8, n=227, 303	0.4 Milliliters per minute per 1.73meter^2 Standard Deviation 9.88	-1.5 Milliliters per minute per 1.73meter^2 Standard Deviation 8.06
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 12, n=295, 297	0.3 Milliliters per minute per 1.73meter^2 Standard Deviation 10.28	-1.9 Milliliters per minute per 1.73meter^2 Standard Deviation 8.02
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 16, n=284, 297	0.4 Milliliters per minute per 1.73meter^2 Standard Deviation 10.63	-1.9 Milliliters per minute per 1.73meter^2 Standard Deviation 8.69
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 20, n=277, 302	-1.0 Milliliters per minute per 1.73meter^2 Standard Deviation 10.37	-2.4 Milliliters per minute per 1.73meter^2 Standard Deviation 8.55
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 24, n=283, 298	-1.0 Milliliters per minute per 1.73meter^2 Standard Deviation 10.52	-2.3 Milliliters per minute per 1.73meter^2 Standard Deviation 8.76
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 28, n=267, 296	-1.8 Milliliters per minute per 1.73meter^2 Standard Deviation 11.47	-2.4 Milliliters per minute per 1.73meter^2 Standard Deviation 8.93
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 32, n=274, 294	-1.2 Milliliters per minute per 1.73meter^2 Standard Deviation 11.11	-3.0 Milliliters per minute per 1.73meter^2 Standard Deviation 8.94
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 36, n=273, 292	-1.2 Milliliters per minute per 1.73meter^2 Standard Deviation 11.26	-2.6 Milliliters per minute per 1.73meter^2 Standard Deviation 8.52
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 40, n=268, 293	-1.7 Milliliters per minute per 1.73meter^2 Standard Deviation 10.70	-2.7 Milliliters per minute per 1.73meter^2 Standard Deviation 9.10
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 44, n=274, 293	-2.1 Milliliters per minute per 1.73meter^2 Standard Deviation 10.45	-2.3 Milliliters per minute per 1.73meter^2 Standard Deviation 8.74
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 48, n=264, 291	-2.5 Milliliters per minute per 1.73meter^2 Standard Deviation 11.80	-1.9 Milliliters per minute per 1.73meter^2 Standard Deviation 8.50

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=275 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=284 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48	-1.8913 Nanomoles per liter Standard Deviation 14.10125	1.4289 Nanomoles per liter Standard Deviation 15.70559

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety population.

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48	13 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: At the time of CVF

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=3 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=4 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Phenotypic Resistance Through Week 48 INI, CAB, resistant, n=3, 4	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, CAB, sensitive, n=3, 4	2 Participants	4 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, DTG, resistant, n=3, 4	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, DTG, partially sensitive, n=3, 4	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, DTG, sensitive, n=3, 4	3 Participants	4 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, EVG, resistant, n=3, 4	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, EVG, sensitive, n=3, 4	2 Participants	4 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, RAL, resistant, n=3, 4	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, RAL, sensitive, n=3, 4	2 Participants	4 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, DLV, resistant, n=3, 3	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, DLV, sensitive, n=3, 3	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, EFV, resistant, n=3, 3	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, EFV, sensitive, n=3, 3	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, ETR, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, ETR, partially sensitive, n=3, 3	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, ETR, sensitive, n=3, 3	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, NVP, resistant, n=3, 3	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, NVP, sensitive, n=3, 3	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, RPV, resistant, n=3, 3	3 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, RPV, sensitive, n=3, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, 3TC, resistant, n=3, 3	0 Participants	1 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, 3TC, sensitive, n=3, 3	3 Participants	2 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ABC, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ABC, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ABC, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, FTC, resistant, n=3, 3	0 Participants	1 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, FTC, sensitive, n=3, 3	3 Participants	2 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, TDF, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, TDF, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, TDF, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ZDV, resistant, n=3, 3	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ZDV, sensitive, n=3, 3	2 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, d4T, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, d4T, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ddI, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ddI, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ddI, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, ATV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, ATV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, DRV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, DRV, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, DRV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, FPV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, FPV, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, FPV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, IDV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, IDV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, LPV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, LPV, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, LPV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, NFV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, NFV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, RTV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, RTV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, SQV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, SQV, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, SQV, sensitive, n=3, 3	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, TPV, resistant, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, TPV, partially sensitive, n=3, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, TPV, sensitive, n=3, 3	3 Participants	3 Participants

SECONDARY outcome

Timeframe: At the time of CVF

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=3 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=4 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Genotypic Resistance Through Week 48 INI, RAL, resistant	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, RAL, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, RAL, sensitive	2 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, DLV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, DLV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, DLV, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, EFV, resistant	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, EFV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, EFV, sensitive	2 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, ETR, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, ETR, resistance possible	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, DTG, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, DTG, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, DTG, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EVG, resistant	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EVG, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EVG, sensitive	2 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, ETR, sensitive	1 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, NVP, resistant	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, NVP, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, NVP, sensitive	2 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, RPV, resistant	3 Participants	1 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, RPV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, RPV, sensitive	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, 3TC, resistant	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, 3TC, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, 3TC, sensitive	3 Participants	2 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ABC, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ABC, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ABC, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, FTC, resistant	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, FTC, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, FTC, sensitive	3 Participants	2 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, TDF, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, TDF, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, TDF, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ZDV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ZDV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ZDV, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, d4T, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, d4T, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, d4T, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ddI, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ddI, resistance possible	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ddI, sensitive	3 Participants	2 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV, resistant	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV, sensitive	2 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV/r, resistance possible	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV/r, sensitive	2 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, DRV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, DRV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, DRV/r, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, FPV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, FPV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, FPV/r, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, IDV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, IDV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, IDV/r, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, LPV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, LPV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, LPV/r, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, NFV, resistant	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, NFV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, NFV, sensitive	2 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, RTV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, RTV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, RTV, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, SQV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, SQV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, SQV/r, sensitive	3 Participants	4 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, TPV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, TPV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, TPV/r, sensitive	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Week 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48 Any AE, PI, n=51, 54	47 Participants	36 Participants
Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48 Any AE, NNRTI, n=155, 155	148 Participants	116 Participants
Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48 Any AE, INI, n=102, 99	99 Participants	68 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

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

Outcome measures

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety population.

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48 PI	2 Participants	2 Participants
Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48 INI	6 Participants	0 Participants
Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48 NNRTI	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 8, n=252	1.2277 Micrograms per milliliter Interval 1.1293 to 1.3346	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 12, n=261	1.6925 Micrograms per milliliter Interval 1.6005 to 1.7897	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 16, n=248	1.9533 Micrograms per milliliter Interval 1.8492 to 2.0632	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 20, n=233	2.1036 Micrograms per milliliter Interval 1.9924 to 2.2209	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 24, n=234	2.2537 Micrograms per milliliter Interval 2.1177 to 2.3984	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 28, n=232	2.4300 Micrograms per milliliter Interval 2.3093 to 2.5569	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 32, n=219	2.4483 Micrograms per milliliter Interval 2.3321 to 2.5703	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 36, n=209	2.4681 Micrograms per milliliter Interval 2.3377 to 2.6057	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 40, n=209	2.5126 Micrograms per milliliter Interval 2.3477 to 2.689	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 44, n=221	2.7748 Micrograms per milliliter Interval 2.6323 to 2.925	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 48, n=217	2.8378 Micrograms per milliliter Interval 2.6763 to 3.009	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Ctrough for RPV LA Evaluable Pre-dose, Week 8, n=251	38.58 Nanograms per milliliter Interval 35.96 to 41.39	—
Ctrough for RPV LA Evaluable Pre-dose, Week 12, n=261	47.00 Nanograms per milliliter Interval 44.5 to 49.64	—
Ctrough for RPV LA Evaluable Pre-dose, Week 16, n=247	53.87 Nanograms per milliliter Interval 50.92 to 56.98	—
Ctrough for RPV LA Evaluable Pre-dose, Week 20, n=233	54.14 Nanograms per milliliter Interval 51.13 to 57.34	—
Ctrough for RPV LA Evaluable Pre-dose, Week 24, n=231	61.26 Nanograms per milliliter Interval 57.8 to 64.93	—
Ctrough for RPV LA Evaluable Pre-dose, Week 28, n=232	66.53 Nanograms per milliliter Interval 62.87 to 70.4	—
Ctrough for RPV LA Evaluable Pre-dose, Week 32, n=218	70.93 Nanograms per milliliter Interval 66.97 to 75.11	—
Ctrough for RPV LA Evaluable Pre-dose, Week 36, n=209	73.00 Nanograms per milliliter Interval 68.54 to 77.75	—
Ctrough for RPV LA Evaluable Pre-dose, Week 40, n=208	76.24 Nanograms per milliliter Interval 71.71 to 81.07	—
Ctrough for RPV LA Evaluable Pre-dose, Week 44, n=223	83.65 Nanograms per milliliter Interval 78.94 to 88.63	—
Ctrough for RPV LA Evaluable Pre-dose, Week 48, n=216	90.28 Nanograms per milliliter Interval 84.92 to 95.98	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=303 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Area Under the Curve (AUC) for CAB LA	2324.29 Hours*microgram per milliliter Interval 2249.85 to 2401.187	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=303 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
AUC for RPV LA	67119.84 Hours*nanogram per milliliter Interval 64426.092 to 69926.208	—

SECONDARY outcome

Timeframe: Week 41- 1 Week post dose

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=251 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41	3.3862 Micrograms per milliliter Interval 3.1804 to 3.6054	—

SECONDARY outcome

Timeframe: Week 41- 1 Week post dose

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=251 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Cmax in Plasma for RPV LA Evaluable at Week 41	110.36 Nanograms per milliliter Interval 103.28 to 117.93	—

SECONDARY outcome

Timeframe: Week 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent PI, n=51, 54	92 Percentage of participants	94 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent INI, n=102, 99	94 Percentage of participants	96 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent NNRTI, n=155, 155	92 Percentage of participants	95 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety population.

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Severity of Adverse Events by Baseline Third Agents INI, Grade 4	1 Participants	2 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents PI, Grade 1	22 Participants	20 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents PI, Grade 2	20 Participants	11 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents PI, Grade 3	4 Participants	4 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents PI, Grade 4	1 Participants	0 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents PI, Grade 5	0 Participants	1 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents INI, Grade 1	40 Participants	40 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents INI, Grade 2	50 Participants	23 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents INI, Grade 3	8 Participants	3 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents INI, Grade 5	0 Participants	0 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents NNRTI, Grade 1	39 Participants	55 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents NNRTI, Grade 2	88 Participants	47 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents NNRTI, Grade 3	15 Participants	12 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents NNRTI, Grade 4	6 Participants	2 Participants
Number of Participants With Severity of Adverse Events by Baseline Third Agents NNRTI, Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: At the time of CVF

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=3 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=4 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, DTG, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, ETR, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, NVP, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, TDF, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, d4T, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, FPV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, LPV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, NFV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, NFV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, EFV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, ETR, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ABC, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, FTC, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ZDV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, FPV/r, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, IDV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, LPV/r, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, LPV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, LPV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, TPV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, TPV/r, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, DTG, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, DTG, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, EVG, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, EVG, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, EVG, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, RAL, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, RAL, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, RAL, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, DLV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, DLV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, DLV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, EFV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, EFV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, EFV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, ETR, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, ETR, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, NVP, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, NVP, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, RPV, resistant, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, RPV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, RPV, sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, 3TC, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, 3TC, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, 3TC, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ABC, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ABC, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ABC, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, FTC, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, FTC, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, FTC, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, NVP, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, TDF, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, TDF, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ZDV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ZDV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ZDV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, d4T, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, d4T, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ddI, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ddI, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, NVP, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, RPV, resistant, n=0, 3	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, RPV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, RPV, sensitive, n=0, 3	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, 3TC, resistant, n=0, 3	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, 3TC, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, 3TC, sensitive, n=0, 3	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ABC, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ABC, resistance possible,, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, FTC, resistant, n=0, 3	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, FTC, sensitive, n=0, 3	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, TDF, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, TDF, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, TDF, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ZDV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ZDV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, d4T, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, d4T, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, d4T, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ddI, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ddI, resistance possible, n=0, 3	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ddI, sensitive, n=0, 3	0 Participants	2 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV/r, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, DRV/r, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, DRV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, DRV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, FPV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, FPV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, IDV/r, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, IDV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, NFV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, NFV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, NFV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, RTV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, RTV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, RTV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, SQV/r, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, SQV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, SQV/r, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, TPV/r, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, TPV/r, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DTG, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DTG, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DTG, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, EVG, resistant, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, EVG, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, EVG, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, RAL, resistant, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, RAL, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, RAL, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, DLV, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DLV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, DLV, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, EFV, resistant, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, EFV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, EFV, sensitive, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, ETR, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, ETR, resistance possible,n=2, 1	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, ETR, sensitive, n=2, 1	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, NVP, resistant, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, NVP, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, NVP, sensitive, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, RPV, resistant, n=2, 1	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, RPV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, RPV, sensitive, n=2, 1	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, 3TC, resistant, n=2, 1	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, 3TC, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, 3TC, sensitive, n=2, 1	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ABC, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ABC, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ABC, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, FTC, resistant, n=2, 1	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, FTC, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, FTC, sensitive, n=2, 1	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, TDF, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, TDF, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, TDF, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ZDV, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ZDV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ZDV, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, d4T, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, d4T, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, d4T, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ddI, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ddI, resistance possible, n=2, 1	0 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ddI, sensitive, n=2, 1	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV, resistant, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV/r, resistance possible, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV/r, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, DRV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, DRV/r, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, DRV/r, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, FPV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, FPV/r, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, FPV/r, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, IDV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, IDV/r, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, IDV/r, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, LPV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, LPV/r, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, LPV/r, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, NFV, resistant, n=2, 1	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, NFV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, NFV, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, RTV, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, RTV, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, RTV, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, SQV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, SQV/r, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, SQV/r, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, TPV/r, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, TPV/r, resistance possible, n=2, 1	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ddI, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, DRV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, DRV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, DRV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, FPV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, FPV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, IDV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, IDV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, IDV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, LPV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, LPV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, NFV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, RTV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, RTV, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, RTV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, SQV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, SQV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, SQV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, TPV/r, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, TPV/r, resistance possible, n=1, 0	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, TPV/r, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DTG, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DTG, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DTG, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, EVG, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, EVG, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, EVG, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, RAL, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, RAL, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, RAL, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, DLV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DLV, resistance possible, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, DLV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, EFV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, EFV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, ETR, resistant,, n=0, 3	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, ETR, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, NVP, resistant, n=0, 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At the time of CVF

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=3 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=4 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, CAB, resistant , n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, CAB, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, DTG, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, EVG, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, EVG, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, RAL, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, RAL, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, ETR, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, ETR, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, TDF, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, NFV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, DTG, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, INI, DTG, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, DLV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, DLV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, EFV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, EFV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, ETR, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, ETR, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, NVP, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, NVP, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, RPV, resistant, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NNRTI, RPV, sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, 3TC, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, 3TC, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ABC, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ABC, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ABC, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, FTC, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, FTC, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, TDF, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, TDF, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, TDF, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ZDV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ZDV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, d4T, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, d4T, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ddI, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ddI, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, NRTI, ddI, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, ATV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, DRV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, DRV, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, DRV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, FPV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, FPV, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, FPV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, IDV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, IDV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, LPV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, LPV, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, LPV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, NFV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, NFV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, RTV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, RTV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, SQV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, SQV, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, SQV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, TPV, resistant, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, TPV, partially sensitive, n=1, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 PI, PI, TPV, sensitive, n=1, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, CAB, resistant , n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, CAB, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DTG, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DTG, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, DTG, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, EVG, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, EVG, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, RAL, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, INI, RAL, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, DLV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, DLV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, EFV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, EFV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, ETR, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, ETR, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, NVP, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, NVP, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, RPV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NNRTI, RPV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, 3TC, resistant, n=0, 3	0 Participants	1 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, 3TC, sensitive, n=0, 3	0 Participants	2 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ABC, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ABC, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ABC, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, FTC, resistant, n=0, 3	0 Participants	1 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, FTC, sensitive, n=0, 3	0 Participants	2 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, TDF, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, TDF, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ZDV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ZDV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, d4T, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, d4T, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ddI, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ddI, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, NRTI, ddI, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, ATV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, DRV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, DRV, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, DRV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, FPV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, FPV, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, FPV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, IDV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, IDV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, LPV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, LPV, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, LPV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, NFV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, RTV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, RTV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, SQV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, SQV, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, SQV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, TPV, resistant, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, TPV, partially sensitive, n=0, 3	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 INI, PI, TPV, sensitive, n=0, 3	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, CAB, resistant , n=2, 1	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, CAB, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DTG, resistant, n=2, 1	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DTG, partially sensitive, n=2, 1	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, DTG, sensitive, n=2, 1	2 Participants	1 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, EVG, resistant, n=2, 1	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, EVG, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, RAL, resistant, n=2, 1	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, INI, RAL, sensitive, n=2, 1	1 Participants	1 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, DLV, resistant, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, DLV, sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, EFV, resistant, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, EFV, sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, ETR, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, ETR, partially sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, ETR, sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, NVP, resistant, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, NVP, sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, RPV, resistant, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NNRTI, RPV, sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, 3TC, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, 3TC, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ABC, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ABC, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ABC, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, FTC, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, FTC, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, TDF, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, TDF, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, TDF, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ZDV, resistant, n=2, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ZDV, sensitive, n=2, 0	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, d4T, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, d4T, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ddI, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ddI, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, NRTI, ddI, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, ATV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, DRV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, DRV, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, DRV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, FPV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, FPV, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, FPV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, IDV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, IDV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, LPV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, LPV, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, LPV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, NFV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, NFV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, RTV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, RTV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, SQV, resistant, n=2,0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, SQV, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, SQV, sensitive, n=2, 0	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, TPV, resistant, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, TPV, partially sensitive, n=2, 0	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48 NNRTI, PI, TPV, sensitive, n=2, 0	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 5 and at Weeks 41 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=296 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Bother of ISRs, Week 41	-0.21 Scores on the scale Standard Deviation 0.532	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Bother of ISRs, Week 48	-0.21 Scores on the scale Standard Deviation 0.524	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Leg movement, Week 41	-0.52 Scores on the scale Standard Deviation 0.903	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Leg movement, Week 48	-0.59 Scores on the scale Standard Deviation 0.950	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Sleep, Week 41	-0.56 Scores on the scale Standard Deviation 0.877	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Sleep, Week 48	-0.56 Scores on the scale Standard Deviation 0.937	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Acceptance, Week 41	-0.49 Scores on the scale Standard Deviation 1.094	—
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm Acceptance, Week 48	-0.54 Scores on the scale Standard Deviation 1.080	—

SECONDARY outcome

Timeframe: Weeks 5, 41 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 5, total, n=296	141 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction,Week 5, very acceptable, n=296	77 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 5, moderate, n=296	54 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 5, little, n=296	15 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 5, not at all, n=296	9 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 5, total, n=296	86 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 5, very acceptable, n=296	103 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 5, moderate, n=296	59 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 5, little, n=296	29 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 5, not at all, n=296	19 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 41, total, n=300	188 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 41, very acceptable, n=300	77 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 41, moderate, n=300	24 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 41, little, n=300	6 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 41, not at all, n=300	5 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 41, total, n=300	166 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 41, very acceptable, n=300	85 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 41, moderate, n=300	31 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 41, little, n=300	12 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 41, not at all, n=300	6 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, week 48, total, n=303	202 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 48, very acceptable, n=303	69 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 48, moderate, n=303	21 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 48, little, n=303	8 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Local reaction, Week 48, not at all, n=303	3 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 48, total, n=303	168 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 48, very acceptable, n=303	95 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 48, moderate, n=303	26 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 48, little, n=303	11 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm Pain, Week 48, not at all, n=303	3 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 24 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire Week 24, n=292, 291	1.0 Scores on a scale Interval -0.6 to 2.6	1.1 Scores on a scale Interval -0.5 to 2.7
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire Week 48, n=292, 297	1.1 Scores on a scale Interval -0.6 to 2.8	0.1 Scores on a scale Interval -1.6 to 1.7

SECONDARY outcome

Timeframe: Baseline and at Weeks 24 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline in HIV Medication, MEDWO Using HATQoL Week 24, n=292, 290	4.2 Scores on a scale Interval 2.7 to 5.8	-0.7 Scores on a scale Interval -2.2 to 0.9
Change From Baseline in HIV Medication, MEDWO Using HATQoL Week 48, n=292, 296	4.0 Scores on a scale Interval 2.3 to 5.7	-2.4 Scores on a scale Interval -4.1 to -0.8

SECONDARY outcome

Timeframe: Baseline and at Weeks 24 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline in DISWO Using HATQoL Week 24, n=291, 290	8.3 Scores on a scale Interval 5.6 to 11.0	3.0 Scores on a scale Interval 0.3 to 5.8
Change From Baseline in DISWO Using HATQoL Week 48, n=291, 296	4.6 Scores on a scale Interval 1.7 to 7.6	2.6 Scores on a scale Interval -0.3 to 5.6

SECONDARY outcome

Timeframe: Baseline and at Weeks 24 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) Total score, Week 24, n=291, 289	0.0 Scores on a scale Interval -0.3 to 0.4	-0.2 Scores on a scale Interval -0.5 to 0.1
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) Total score, Week 48, n=293, 296	-0.0 Scores on a scale Interval -0.4 to 0.3	0.0 Scores on a scale Interval -0.3 to 0.4
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) MCS, Week 24, n=289, 286	0.288 Scores on a scale Interval -0.579 to 1.155	-0.388 Scores on a scale Interval -1.259 to 0.484
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) MCS, Week 48, n=291, 293	0.260 Scores on a scale Interval -0.638 to 1.158	-0.375 Scores on a scale Interval -1.27 to 0.52
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) PCS, Week 24, n=286, 288	0.650 Scores on a scale Interval 0.087 to 1.213	-0.047 Scores on a scale Interval -0.608 to 0.514
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) PCS, Week 48, n=288, 295	0.758 Scores on a scale Interval 0.184 to 1.332	0.062 Scores on a scale Interval -0.505 to 0.629

SECONDARY outcome

Timeframe: Baseline and at Weeks 4b, 24 and 44

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 48

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=275 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change in Treatment Satisfaction Over Time Using HIVTSQ Change (HIVTSQc) at Week 48 in Q4W Arm	29.05 Scores on a scale Standard Deviation 6.978	—

SECONDARY outcome

Timeframe: Baseline and at Weeks 8, 24 and 48

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire Week 8, n=302, 287	8.9 Scores on a scale Interval 6.3 to 11.6	1.0 Scores on a scale Interval -1.7 to 3.8
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire Week 24, 303, 295	12.3 Scores on a scale Interval 9.9 to 14.8	5.5 Scores on a scale Interval 3.0 to 8.0
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire Week 48, n=302, 298	13.7 Scores on a scale Interval 11.2 to 16.3	3.0 Scores on a scale Interval 0.4 to 5.6

SECONDARY outcome

Timeframe: Weeks 4b, 5, 40 and 41

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

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

Outcome measures

Outcome measures
Measure	CAB LA+RPV LA (Q4W) n=278 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm Week 5	2.0 Scores on a scale Standard Deviation 2.94	—
Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm Week 40	0.5 Scores on a scale Standard Deviation 2.79	—
Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm Week 41	0.4 Scores on a scale Standard Deviation 2.83	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4b, 24 and 44

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

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

Outcome measures

OTHER_PRE_SPECIFIED outcome

Timeframe: Upto Week 48

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

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

Outcome measures

Outcome data not reported

Adverse Events

CAB LA+RPV LA (Q4W)

Serious events: 13 serious events

Other events: 263 other events

Deaths: 0 deaths

Current ART

Serious events: 14 serious events

Other events: 117 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CAB LA+RPV LA (Q4W) n=308 participants at risk During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 participants at risk During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Nervous system disorders Headache	11.0% 34/308 • Number of events 48 • Up to Week 52 AEs and SAEs were collected in Safety population.	5.5% 17/308 • Number of events 19 • Up to Week 52 AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Diarrhoea	7.1% 22/308 • Number of events 24 • Up to Week 52 AEs and SAEs were collected in Safety population.	4.9% 15/308 • Number of events 17 • Up to Week 52 AEs and SAEs were collected in Safety population.
Musculoskeletal and connective tissue disorders Back pain	6.5% 20/308 • Number of events 22 • Up to Week 52 AEs and SAEs were collected in Safety population.	3.2% 10/308 • Number of events 12 • Up to Week 52 AEs and SAEs were collected in Safety population.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 16/308 • Number of events 20 • Up to Week 52 AEs and SAEs were collected in Safety population.	4.5% 14/308 • Number of events 16 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Influenza	5.5% 17/308 • Number of events 19 • Up to Week 52 AEs and SAEs were collected in Safety population.	4.5% 14/308 • Number of events 15 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Respiratory tract infection viral	3.6% 11/308 • Number of events 12 • Up to Week 52 AEs and SAEs were collected in Safety population.	5.5% 17/308 • Number of events 23 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Injection site pain	75.0% 231/308 • Number of events 1208 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Injection site nodule	12.0% 37/308 • Number of events 54 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Injection site induration	9.7% 30/308 • Number of events 54 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Pyrexia	6.8% 21/308 • Number of events 29 • Up to Week 52 AEs and SAEs were collected in Safety population.	2.9% 9/308 • Number of events 9 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Fatigue	7.1% 22/308 • Number of events 29 • Up to Week 52 AEs and SAEs were collected in Safety population.	1.9% 6/308 • Number of events 9 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Injection site swelling	7.5% 23/308 • Number of events 48 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Nasopharyngitis	16.9% 52/308 • Number of events 87 • Up to Week 52 AEs and SAEs were collected in Safety population.	13.6% 42/308 • Number of events 58 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Upper respiratory tract infection	10.4% 32/308 • Number of events 48 • Up to Week 52 AEs and SAEs were collected in Safety population.	8.1% 25/308 • Number of events 30 • Up to Week 52 AEs and SAEs were collected in Safety population.

Additional Information

GSK Reponse Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

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

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

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

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

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

Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 28, n=42, 53	100.6 Milliliters per minute per 1.73meter^2 Standard Deviation 16.62	100.8 Milliliters per minute per 1.73meter^2 Standard Deviation 14.58
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Baseline, n=51, 54	105.2 Milliliters per minute per 1.73meter^2 Standard Deviation 15.67	104.9 Milliliters per minute per 1.73meter^2 Standard Deviation 15.22
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 4, n=51, 53	103.0 Milliliters per minute per 1.73meter^2 Standard Deviation 15.59	102.1 Milliliters per minute per 1.73meter^2 Standard Deviation 15.68
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 8, n=34, 53	104.3 Milliliters per minute per 1.73meter^2 Standard Deviation 14.52	103.5 Milliliters per minute per 1.73meter^2 Standard Deviation 15.61
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 12, n=50, 52	107.1 Milliliters per minute per 1.73meter^2 Standard Deviation 14.95	101.1 Milliliters per minute per 1.73meter^2 Standard Deviation 15.94
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 16, n=48, 53	105.4 Milliliters per minute per 1.73meter^2 Standard Deviation 15.88	101.8 Milliliters per minute per 1.73meter^2 Standard Deviation 15.99
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 20, n=46, 53	102.9 Milliliters per minute per 1.73meter^2 Standard Deviation 17.17	99.8 Milliliters per minute per 1.73meter^2 Standard Deviation 16.53
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 24, n=47, 53	103.3 Milliliters per minute per 1.73meter^2 Standard Deviation 14.64	101.0 Milliliters per minute per 1.73meter^2 Standard Deviation 15.54
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 32, n=45, 51	101.0 Milliliters per minute per 1.73meter^2 Standard Deviation 17.38	100.4 Milliliters per minute per 1.73meter^2 Standard Deviation 16.04
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 36, n=44, 50	100.7 Milliliters per minute per 1.73meter^2 Standard Deviation 16.68	101.7 Milliliters per minute per 1.73meter^2 Standard Deviation 14.42
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 40, n=42, 51	100.2 Milliliters per minute per 1.73meter^2 Standard Deviation 14.54	100.3 Milliliters per minute per 1.73meter^2 Standard Deviation 15.51
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 44, n=47, 51	99.8 Milliliters per minute per 1.73meter^2 Standard Deviation 18.00	101.0 Milliliters per minute per 1.73meter^2 Standard Deviation 15.31
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 48, n=43, 50	98.8 Milliliters per minute per 1.73meter^2 Standard Deviation 17.31	102.2 Milliliters per minute per 1.73meter^2 Standard Deviation 15.45
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Baseline, n=102, 99	92.3 Milliliters per minute per 1.73meter^2 Standard Deviation 17.62	94.9 Milliliters per minute per 1.73meter^2 Standard Deviation 18.82
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 4, n=99, 95	93.4 Milliliters per minute per 1.73meter^2 Standard Deviation 15.07	93.1 Milliliters per minute per 1.73meter^2 Standard Deviation 18.22
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 8, n=72, 98	94.4 Milliliters per minute per 1.73meter^2 Standard Deviation 17.05	93.0 Milliliters per minute per 1.73meter^2 Standard Deviation 18.12
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 12, n=99, 93	94.5 Milliliters per minute per 1.73meter^2 Standard Deviation 16.82	91.6 Milliliters per minute per 1.73meter^2 Standard Deviation 18.81
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 16, n=93, 96	94.9 Milliliters per minute per 1.73meter^2 Standard Deviation 16.02	94.4 Milliliters per minute per 1.73meter^2 Standard Deviation 18.30
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 20, n=93, 97	95.3 Milliliters per minute per 1.73meter^2 Standard Deviation 15.97	93.3 Milliliters per minute per 1.73meter^2 Standard Deviation 17.48
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 24, n=94, 94	95.6 Milliliters per minute per 1.73meter^2 Standard Deviation 15.88	93.1 Milliliters per minute per 1.73meter^2 Standard Deviation 17.21
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 28, n=89, 93	95.4 Milliliters per minute per 1.73meter^2 Standard Deviation 17.00	93.6 Milliliters per minute per 1.73meter^2 Standard Deviation 17.89
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 32, n=92, 95	94.8 Milliliters per minute per 1.73meter^2 Standard Deviation 17.16	93.1 Milliliters per minute per 1.73meter^2 Standard Deviation 16.94
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 36, n=94, 95	95.6 Milliliters per minute per 1.73meter^2 Standard Deviation 15.81	92.7 Milliliters per minute per 1.73meter^2 Standard Deviation 15.65
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 40, n=89, 95	94.8 Milliliters per minute per 1.73meter^2 Standard Deviation 16.32	92.9 Milliliters per minute per 1.73meter^2 Standard Deviation 18.15
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 44, n=91, 94	94.8 Milliliters per minute per 1.73meter^2 Standard Deviation 15.64	93.4 Milliliters per minute per 1.73meter^2 Standard Deviation 17.94
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 48, n=90, 94	95.4 Milliliters per minute per 1.73meter^2 Standard Deviation 16.20	93.5 Milliliters per minute per 1.73meter^2 Standard Deviation 17.00
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Baseline, n=155, 155	104.4 Milliliters per minute per 1.73meter^2 Standard Deviation 17.78	103.7 Milliliters per minute per 1.73meter^2 Standard Deviation 16.85
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 4, n=151, 153	100.8 Milliliters per minute per 1.73meter^2 Standard Deviation 18.35	101.5 Milliliters per minute per 1.73meter^2 Standard Deviation 17.72
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 8, n=121, 152	102.3 Milliliters per minute per 1.73meter^2 Standard Deviation 17.23	102.2 Milliliters per minute per 1.73meter^2 Standard Deviation 16.85
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 12, n=146, 152	103.1 Milliliters per minute per 1.73meter^2 Standard Deviation 18.02	103.2 Milliliters per minute per 1.73meter^2 Standard Deviation 17.47
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 16, n=143, 148	102.5 Milliliters per minute per 1.73meter^2 Standard Deviation 17.66	101.0 Milliliters per minute per 1.73meter^2 Standard Deviation 18.66
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 20, n=138, 152	101.0 Milliliters per minute per 1.73meter^2 Standard Deviation 17.94	101.8 Milliliters per minute per 1.73meter^2 Standard Deviation 17.61
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 24, n=142, 151	99.6 Milliliters per minute per 1.73meter^2 Standard Deviation 18.18	101.7 Milliliters per minute per 1.73meter^2 Standard Deviation 17.43
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 28, n=136, 150	99.9 Milliliters per minute per 1.73meter^2 Standard Deviation 18.23	101.7 Milliliters per minute per 1.73meter^2 Standard Deviation 17.20
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 32, n=137, 148	101.3 Milliliters per minute per 1.73meter^2 Standard Deviation 16.10	101.0 Milliliters per minute per 1.73meter^2 Standard Deviation 17.79
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 36, n=135, 147	100.8 Milliliters per minute per 1.73meter^2 Standard Deviation 18.02	101.4 Milliliters per minute per 1.73meter^2 Standard Deviation 17.46
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 40, n=137, 147	100.5 Milliliters per minute per 1.73meter^2 Standard Deviation 18.40	101.6 Milliliters per minute per 1.73meter^2 Standard Deviation 16.68
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 44, n=136, 148	99.9 Milliliters per minute per 1.73meter^2 Standard Deviation 17.23	101.8 Milliliters per minute per 1.73meter^2 Standard Deviation 16.96
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 48, n=131, 147	98.7 Milliliters per minute per 1.73meter^2 Standard Deviation 17.35	102.1 Milliliters per minute per 1.73meter^2 Standard Deviation 16.83

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

Measure	CAB LA+RPV LA (Q4W) n=308 Participants During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 Participants During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 48, n=90, 94	3.0 Milliliters per minute per 1.73meter^2 Standard Deviation 9.74	-1.6 Milliliters per minute per 1.73meter^2 Standard Deviation 9.73
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 4, n=51, 53	-2.2 Milliliters per minute per 1.73meter^2 Standard Deviation 9.77	-2.8 Milliliters per minute per 1.73meter^2 Standard Deviation 8.02
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 8, n=34, 53	-1.1 Milliliters per minute per 1.73meter^2 Standard Deviation 10.19	-1.3 Milliliters per minute per 1.73meter^2 Standard Deviation 6.58
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 12, n=50, 52	2.2 Milliliters per minute per 1.73meter^2 Standard Deviation 11.04	-3.7 Milliliters per minute per 1.73meter^2 Standard Deviation 6.99
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 16, n=48, 53	0.9 Milliliters per minute per 1.73meter^2 Standard Deviation 11.02	-3.1 Milliliters per minute per 1.73meter^2 Standard Deviation 7.63
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 20, n=46, 53	-2.2 Milliliters per minute per 1.73meter^2 Standard Deviation 10.80	-5.0 Milliliters per minute per 1.73meter^2 Standard Deviation 9.26
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 24, n=47, 53	-1.0 Milliliters per minute per 1.73meter^2 Standard Deviation 8.60	-3.8 Milliliters per minute per 1.73meter^2 Standard Deviation 8.51
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 28, n=42, 53	-4.2 Milliliters per minute per 1.73meter^2 Standard Deviation 11.82	-4.0 Milliliters per minute per 1.73meter^2 Standard Deviation 8.46
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 32, n=45, 51	-3.2 Milliliters per minute per 1.73meter^2 Standard Deviation 12.30	-5.2 Milliliters per minute per 1.73meter^2 Standard Deviation 7.56
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 36, n=44, 50	-3.8 Milliliters per minute per 1.73meter^2 Standard Deviation 8.68	-3.6 Milliliters per minute per 1.73meter^2 Standard Deviation 8.08
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 40, n=42, 51	-2.4 Milliliters per minute per 1.73meter^2 Standard Deviation 10.71	-4.9 Milliliters per minute per 1.73meter^2 Standard Deviation 7.25
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 44, n=47, 51	-4.5 Milliliters per minute per 1.73meter^2 Standard Deviation 10.63	-4.2 Milliliters per minute per 1.73meter^2 Standard Deviation 7.58
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance PI, Week 48, n=43, 50	-5.6 Milliliters per minute per 1.73meter^2 Standard Deviation 12.22	-3.1 Milliliters per minute per 1.73meter^2 Standard Deviation 6.54
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 4, n=99, 95	1.0 Milliliters per minute per 1.73meter^2 Standard Deviation 9.51	-2.0 Milliliters per minute per 1.73meter^2 Standard Deviation 11.28
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 8, n=72, 98	3.9 Milliliters per minute per 1.73meter^2 Standard Deviation 9.84	-1.9 Milliliters per minute per 1.73meter^2 Standard Deviation 9.28
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 12, n=99, 93	2.1 Milliliters per minute per 1.73meter^2 Standard Deviation 11.32	-3.1 Milliliters per minute per 1.73meter^2 Standard Deviation 9.60
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 16, n=93, 96	3.6 Milliliters per minute per 1.73meter^2 Standard Deviation 9.71	-0.7 Milliliters per minute per 1.73meter^2 Standard Deviation 8.59
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 20, n=93, 97	3.5 Milliliters per minute per 1.73meter^2 Standard Deviation 9.77	-1.7 Milliliters per minute per 1.73meter^2 Standard Deviation 9.58
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 24, n=94, 94	3.9 Milliliters per minute per 1.73meter^2 Standard Deviation 9.26	-1.8 Milliliters per minute per 1.73meter^2 Standard Deviation 10.38
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 28, n=89, 93	3.1 Milliliters per minute per 1.73meter^2 Standard Deviation 11.02	-1.6 Milliliters per minute per 1.73meter^2 Standard Deviation 9.55
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 32, n=92, 95	3.0 Milliliters per minute per 1.73meter^2 Standard Deviation 10.40	-2.0 Milliliters per minute per 1.73meter^2 Standard Deviation 9.69
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 36, n=94, 95	3.7 Milliliters per minute per 1.73meter^2 Standard Deviation 11.19	-2.3 Milliliters per minute per 1.73meter^2 Standard Deviation 9.30
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 40, n=89, 95	2.7 Milliliters per minute per 1.73meter^2 Standard Deviation 10.45	-2.6 Milliliters per minute per 1.73meter^2 Standard Deviation 10.14
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance INI, Week 44, n=91, 94	2.6 Milliliters per minute per 1.73meter^2 Standard Deviation 9.88	-1.6 Milliliters per minute per 1.73meter^2 Standard Deviation 10.90
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 4, n=151, 153	-3.4 Milliliters per minute per 1.73meter^2 Standard Deviation 9.06	-2.3 Milliliters per minute per 1.73meter^2 Standard Deviation 8.10
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 8, n=121, 152	-1.1 Milliliters per minute per 1.73meter^2 Standard Deviation 9.35	-1.3 Milliliters per minute per 1.73meter^2 Standard Deviation 7.72
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 12, n=146, 152	-1.7 Milliliters per minute per 1.73meter^2 Standard Deviation 8.90	-0.5 Milliliters per minute per 1.73meter^2 Standard Deviation 7.03
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 16, n=143, 148	-1.8 Milliliters per minute per 1.73meter^2 Standard Deviation 10.60	-2.3 Milliliters per minute per 1.73meter^2 Standard Deviation 9.06
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 20, n=138, 152	-3.7 Milliliters per minute per 1.73meter^2 Standard Deviation 9.64	-1.9 Milliliters per minute per 1.73meter^2 Standard Deviation 7.41
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 24, n=142, 151	-4.3 Milliliters per minute per 1.73meter^2 Standard Deviation 10.67	-2.0 Milliliters per minute per 1.73meter^2 Standard Deviation 7.67
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 28, n=136, 150	-4.3 Milliliters per minute per 1.73meter^2 Standard Deviation 10.68	-2.4 Milliliters per minute per 1.73meter^2 Standard Deviation 8.67
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 32, n=137, 148	-3.3 Milliliters per minute per 1.73meter^2 Standard Deviation 10.42	-2.8 Milliliters per minute per 1.73meter^2 Standard Deviation 8.80
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 36, n=135, 147	-3.8 Milliliters per minute per 1.73meter^2 Standard Deviation 10.97	-2.5 Milliliters per minute per 1.73meter^2 Standard Deviation 8.16
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 40, n=137, 147	-4.4 Milliliters per minute per 1.73meter^2 Standard Deviation 9.97	-2.0 Milliliters per minute per 1.73meter^2 Standard Deviation 8.90
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 44, n=136, 148	-4.4 Milliliters per minute per 1.73meter^2 Standard Deviation 9.75	-2.0 Milliliters per minute per 1.73meter^2 Standard Deviation 7.45
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance NNRTI, Week 48, n=131, 147	-5.2 Milliliters per minute per 1.73meter^2 Standard Deviation 11.72	-1.6 Milliliters per minute per 1.73meter^2 Standard Deviation 8.25

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

Measure	CAB LA+RPV LA (Q4W) n=308 participants at risk During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	Current ART n=308 participants at risk During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor \[PI\] or integrase inhibitor \[INI\] or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Infections and infestations Anal abscess	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Appendicitis	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Gastroenteritis Escherichia coli	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Liver abscess	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Pneumonia	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Pyelonephritis acute	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Viral infection	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Colitis	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.65% 2/308 • Number of events 3 • Up to Week 52 AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Pancreatitis acute	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Vomiting	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Animal bite	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Eye injury	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Overdose	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Hepatobiliary disorders Cholecystitis acute	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Hepatobiliary disorders Hepatocellular injury	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Hepatobiliary disorders Hyperbilirubinaemia	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
General disorders Chest discomfort	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Investigations Liver function test abnormal	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Musculoskeletal and connective tissue disorders Back pain	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.
Nervous system disorders Cerebrovascular accident	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Psychiatric disorders Suicidal ideation	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Hepatitis A	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.
Infections and infestations Acute hepatitis B	0.32% 1/308 • Number of events 1 • Up to Week 52 AEs and SAEs were collected in Safety population.	0.00% 0/308 • Up to Week 52 AEs and SAEs were collected in Safety population.