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

• ClinicalTrials.gov Identifier: NCT02951052
• Recruitment Status: Active, not recruiting
• First Posted: November 1, 2016
• Results First Posted: June 13, 2019
• Last Update Posted: November 23, 2022
• Sponsor: ViiV Healthcare
• Collaborators: Janssen Pharmaceuticals; GlaxoSmithKline
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Infection, Human Immunodeficiency Virus; HIV Infections
• Interventions: Drug: Cabotegravir (CAB) tablet; Drug: Rilpivirine (RPV) tablet; Drug: Cabotegravir - Injectable Suspension (CAB LA); Drug: Rilpivirine - Injectable Suspension (RPV LA); Drug: 2 NRTIs plus an INI, NNRTI, or PI
• Enrollment: 618

Participant Flow

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

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Period Title: Overall Study
Started	308	308
Completed	281	290
Not Completed	27	18
Reason Not Completed
Adverse Event	13	5
Withdrawal by Subject	1	5
Physician Decision	2	0
Lost to Follow-up	1	1
Protocol-specified withdrawal criterion	1	0
Protocol Violation	5	3
Lack of Efficacy	3	4
Ongoing	1	0

Baseline Characteristics

Arm/Group Title		CAB LA+RPV LA (Q4W)	Current ART	Total
Arm/Group Description		During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA	Total of all reporting groups
Overall Number of Baseline Participants		308	308	616
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	308 participants	308 participants	616 participants
		41.6 (9.99)	43.2 (11.43)	42.4 (10.76)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	308 participants	308 participants	616 participants
	Female	99 32.1%	104 33.8%	203 33.0%
	Male	209 67.9%	204 66.2%	413 67.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	308 participants	308 participants	616 participants
American Indian (AI) or Alaska Native (AN)		8 2.6%	8 2.6%	16 2.6%
Asian-Central South Asian Heritage		1 0.3%	0 0.0%	1 0.2%
Asian-Japanese/East/South-East Asian Heritage		21 6.8%	13 4.2%	34 5.5%
Black or African American		62 20.1%	77 25.0%	139 22.6%
Native Hawaiian or other Pacific Islander		0 0.0%	1 0.3%	1 0.2%
White		214 69.5%	207 67.2%	421 68.3%
AI or AN & Black/African American		0 0.0%	1 0.3%	1 0.2%
AI or AN & Black/African American & White		1 0.3%	1 0.3%	2 0.3%
Black/African American or White		1 0.3%	0 0.0%	1 0.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed	308	308
Measure Type: Count of Participants; Unit of Measure: Participants
	5 1.6%	3 1.0%

Statistical Analysis 1

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

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT-E Population

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

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA+RPV LA (Q4W), Current ART
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in the proportion of participants with HIV-1 RNA<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.
Method of Estimation	Estimation Parameter	Adjusted difference in proportion
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -6.7 to 0.7
	Estimation Comments	Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT-E Population

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

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed	308	308
Measure Type: Count of Participants; Unit of Measure: Participants
Week 8	1 0.3%	0 0.0%
Week 12	2 0.6%	0 0.0%
Week 20	2 0.6%	2 0.6%
Week 24	3 1.0%	2 0.6%
Week 32	3 1.0%	3 1.0%
Week 40	3 1.0%	4 1.3%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT-E Population

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

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed	308	308
Measure Type: Count of Participants; Unit of Measure: Participants
Any non-SAE	263 85.4%	117 38.0%
Any SAE	13 4.2%	14 4.5%

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:	During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed	308	308
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	101 32.8%	115 37.3%
Grade 2	158 51.3%	81 26.3%
Grade 3	27 8.8%	19 6.2%
Grade 4	8 2.6%	4 1.3%
Grade 5	0 0.0%	1 0.3%

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:		During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed		308	308
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Basophils, Baseline, n=308, 307	Number Analyzed	308 participants	307 participants
		0.021 (0.0147)	0.021 (0.0148)
Basophils, Week 4, n=299, 291	Number Analyzed	299 participants	291 participants
		0.024 (0.0153)	0.023 (0.0161)
Basophils, Week 8, n=216, 294	Number Analyzed	216 participants	294 participants
		0.023 (0.0188)	0.022 (0.0155)
Basophils, Week 12, n=293, 290	Number Analyzed	293 participants	290 participants
		0.022 (0.0154)	0.022 (0.0157)
Basophils, Week 16, n=274, 292	Number Analyzed	274 participants	292 participants
		0.022 (0.0147)	0.022 (0.0140)
Basophils, Week 20, n=273, 292	Number Analyzed	273 participants	292 participants
		0.023 (0.0182)	0.024 (0.0195)
Basophils, Week 24, n=277, 292	Number Analyzed	277 participants	292 participants
		0.023 (0.0139)	0.024 (0.0133)
Basophils, Week 28, n=266, 295	Number Analyzed	266 participants	295 participants
		0.024 (0.0150)	0.023 (0.0138)
Basophils, Week 32, n=262, 283	Number Analyzed	262 participants	283 participants
		0.025 (0.0171)	0.024 (0.0159)
Basophils, Week 36, n=260, 282	Number Analyzed	260 participants	282 participants
		0.029 (0.0211)	0.028 (0.0190)
Basophils, Week 40, n=258, 280	Number Analyzed	258 participants	280 participants
		0.035 (0.0266)	0.031 (0.0206)
Basophils, Week 44, n=258, 268	Number Analyzed	258 participants	268 participants
		0.037 (0.0275)	0.033 (0.0222)
Basophils, Week 48, n=246, 274	Number Analyzed	246 participants	274 participants
		0.040 (0.0253)	0.039 (0.0249)
Eosinophils, Baseline, n=308, 307	Number Analyzed	308 participants	307 participants
		0.142 (0.1409)	0.140 (0.1538)
Eosinophils, Week 4, n=299, 291	Number Analyzed	299 participants	291 participants
		0.168 (0.1587)	0.145 (0.1422)
Eosinophils, Week 8, n=216, 294	Number Analyzed	216 participants	294 participants
		0.154 (0.1379)	0.131 (0.1333)
Eosinophils, Week 12, n=293, 290	Number Analyzed	293 participants	290 participants
		0.142 (0.1172)	0.132 (0.1471)
Eosinophils, Week 16, n=274, 292	Number Analyzed	274 participants	292 participants
		0.153 (0.1395)	0.131 (0.1584)
Eosinophils, Week 20, n=273, 292	Number Analyzed	273 participants	292 participants
		0.152 (0.1480)	0.116 (0.1094)
Eosinophils, Week 24, n=277, 292	Number Analyzed	277 participants	292 participants
		0.143 (0.1323)	0.121 (0.1337)
Eosinophils, Week 28, n=266, 295	Number Analyzed	266 participants	295 participants
		0.144 (0.1266)	0.129 (0.1320)
Eosinophils, Week 32, n=262, 283	Number Analyzed	262 participants	283 participants
		0.170 (0.1643)	0.131 (0.1319)
Eosinophils, Week 36, n=260, 282	Number Analyzed	260 participants	282 participants
		0.150 (0.1403)	0.132 (0.1162)
Eosinophils, Week 40, n=258, 280	Number Analyzed	258 participants	280 participants
		0.161 (0.1206)	0.132 (0.1124)
Eosinophils, Week 44, n=258, 268	Number Analyzed	258 participants	268 participants
		0.175 (0.1471)	0.136 (0.1126)
Eosinophils, Week 48, n=246, 274	Number Analyzed	246 participants	274 participants
		0.174 (0.1412)	0.140 (0.1265)
Leukocytes, Baseline, n=308, 307	Number Analyzed	308 participants	307 participants
		5.87 (1.928)	5.65 (1.897)
Leukocytes, Week 4, n=300, 298	Number Analyzed	300 participants	298 participants
		6.43 (2.154)	5.81 (1.733)
Leukocytes, Week 8, n=217, 301	Number Analyzed	217 participants	301 participants
		6.14 (1.875)	5.64 (1.663)
Leukocytes, Week 12, n=294, 293	Number Analyzed	294 participants	293 participants
		6.24 (1.876)	5.77 (1.751)
Leukocytes, Week 16, n=279, 295	Number Analyzed	279 participants	295 participants
		6.27 (1.920)	5.82 (1.756)
Leukocytes, Week 20, n=276, 298	Number Analyzed	276 participants	298 participants
		6.27 (1.947)	5.70 (1.721)
Leukocytes, Week 24, n=279, 294	Number Analyzed	279 participants	294 participants
		6.18 (1.931)	5.78 (1.756)
Leukocytes, Week 28, n=268, 297	Number Analyzed	268 participants	297 participants
		6.08 (1.949)	5.73 (1.637)
Leukocytes, Week 32, n=267, 288	Number Analyzed	267 participants	288 participants
		6.30 (1.914)	5.73 (1.666)
Leukocytes, Week 36, n=264, 285	Number Analyzed	264 participants	285 participants
		6.14 (1.831)	5.80 (1.968)
Leukocytes, Week 40, n=264, 286	Number Analyzed	264 participants	286 participants
		6.24 (2.046)	5.74 (1.713)
Leukocytes, Week 44, n=269, 279	Number Analyzed	269 participants	279 participants
		6.15 (1.884)	5.66 (1.745)
Leukocytes, Week 48, n=252, 282	Number Analyzed	252 participants	282 participants
		6.01 (1.943)	5.62 (1.679)
Lymphocytes, Baseline, n=308, 307	Number Analyzed	308 participants	307 participants
		1.943 (0.6073)	1.940 (0.6880)
Lymphocytes, Week 4, n=299, 291	Number Analyzed	299 participants	291 participants
		2.127 (0.6942)	2.059 (0.6929)
Lymphocytes, Week 8, n=216, 294	Number Analyzed	216 participants	294 participants
		1.995 (0.6347)	1.975 (0.6549)
Lymphocytes, Week 12, n=293, 290	Number Analyzed	293 participants	290 participants
		1.984 (0.6428)	2.026 (0.6996)
Lymphocytes, Week 16, n=274, 292	Number Analyzed	274 participants	292 participants
		2.057 (0.6840)	2.029 (0.6584)
Lymphocytes, Week 20, n=273, 292	Number Analyzed	273 participants	292 participants
		2.035 (0.6140)	2.030 (0.6906)
Lymphocytes, Week 24, n=277, 292	Number Analyzed	277 participants	292 participants
		2.016 (0.6523)	1.980 (0.6047)
Lymphocytes, Week 28, n=266, 295	Number Analyzed	266 participants	295 participants
		2.049 (0.6960)	2.016 (0.6476)
Lymphocytes, Week 32, n=262, 283	Number Analyzed	262 participants	283 participants
		2.020 (0.6157)	2.007 (0.6511)
Lymphocytes, Week 36, n=260, 282	Number Analyzed	260 participants	282 participants
		1.960 (0.6009)	1.984 (0.6444)
Lymphocytes, Week 40, n=258, 280	Number Analyzed	258 participants	280 participants
		1.994 (0.6149)	1.957 (0.6305)
Lymphocytes, Week 44, n=258, 268	Number Analyzed	258 participants	268 participants
		2.016 (0.6457)	1.970 (0.6219)
Lymphocytes, Week 48, n=246, 274	Number Analyzed	246 participants	274 participants
		1.900 (0.5725)	1.915 (0.6204)
Neutrophils, Baseline, n=308, 307	Number Analyzed	308 participants	307 participants
		3.437 (1.6106)	3.209 (1.5748)
Neutrophils, Week 4, n=299, 291	Number Analyzed	299 participants	291 participants
		3.708 (1.8763)	3.244 (1.3931)
Neutrophils, Week 8, n=216, 294	Number Analyzed	216 participants	294 participants
		3.597 (1.6128)	3.190 (1.3370)
Neutrophils, Week 12, n=293, 290	Number Analyzed	293 participants	290 participants
		3.724 (1.5751)	3.268 (1.4153)
Neutrophils, Week 16, n=274, 292	Number Analyzed	274 participants	292 participants
		3.670 (1.6777)	3.308 (1.3870)
Neutrophils, Week 20, n=273, 292	Number Analyzed	273 participants	292 participants
		3.707 (1.6532)	3.188 (1.3345)
Neutrophils, Week 24, n=277, 292	Number Analyzed	277 participants	292 participants
		3.613 (1.5978)	3.289 (1.4381)
Neutrophils, Week 28, n=266, 295	Number Analyzed	266 participants	295 participants
		3.528 (1.5464)	3.221 (1.2962)
Neutrophils, Week 32, n=262, 283	Number Analyzed	262 participants	283 participants
		3.704 (1.6196)	3.228 (1.2909)
Neutrophils, Week 36, n=260, 282	Number Analyzed	260 participants	282 participants
		3.629 (1.5688)	3.314 (1.6341)
Neutrophils, Week 40, n=258, 280	Number Analyzed	258 participants	280 participants
		3.688 (1.7685)	3.280 (1.4190)
Neutrophils, Week 44, n=258, 268	Number Analyzed	258 participants	268 participants
		3.571 (1.5425)	3.169 (1.4140)
Neutrophils, Week 48, n=246, 274	Number Analyzed	246 participants	274 participants
		3.450 (1.5649)	3.172 (1.3627)
Monocytes, Baseline, n=308, 307	Number Analyzed	308 participants	307 participants
		0.353 (0.1745)	0.339 (0.1596)
Monocytes, Week 4, n=299, 291	Number Analyzed	299 participants	291 participants
		0.404 (0.1951)	0.367 (0.1694)
Monocytes, Week 8, n=216, 294	Number Analyzed	216 participants	294 participants
		0.369 (0.1628)	0.358 (0.1875)
Monocytes, Week 12, n=293, 290	Number Analyzed	293 participants	290 participants
		0.375 (0.1563)	0.342 (0.1693)
Monocytes, Week 16, n=274, 292	Number Analyzed	274 participants	292 participants
		0.364 (0.1537)	0.345 (0.1645)
Monocytes, Week 20, n=273, 292	Number Analyzed	273 participants	292 participants
		0.356 (0.1526)	0.342 (0.1632)
Monocytes, Week 24, n=277, 292	Number Analyzed	277 participants	292 participants
		0.370 (0.1632)	0.341 (0.1632)
Monocytes, Week 28, n=266, 295	Number Analyzed	266 participants	295 participants
		0.354 (0.1631)	0.333 (0.1592)
Monocytes, Week 32, n=262, 283	Number Analyzed	262 participants	283 participants
		0.378 (0.1629)	0.351 (0.1801)
Monocytes, Week 36, n=260, 282	Number Analyzed	260 participants	282 participants
		0.376 (0.1593)	0.366 (0.1824)
Monocytes, Week 40, n=258, 280	Number Analyzed	258 participants	280 participants
		0.402 (0.1612)	0.359 (0.1823)
Monocytes, Week 44, n=258, 268	Number Analyzed	258 participants	268 participants
		0.409 (0.1643)	0.388 (0.1795)
Monocytes, Week 48, n=246, 274	Number Analyzed	246 participants	274 participants
		0.407 (0.1600)	0.384 (0.1742)
Platelets, Baseline, n=308, 308	Number Analyzed	308 participants	308 participants
		231.1 (56.75)	232.9 (59.28)
Platelets, Week 4, n=300, 298	Number Analyzed	300 participants	298 participants
		233.5 (55.09)	238.1 (61.98)
Platelets, Week 8, n=216, 298	Number Analyzed	216 participants	298 participants
		227.4 (47.04)	234.0 (61.84)
Platelets, Week 12, n=294, 290	Number Analyzed	294 participants	290 participants
		230.2 (57.32)	237.8 (64.42)
Platelets, Week 16, n=279, 294	Number Analyzed	279 participants	294 participants
		226.1 (56.82)	236.4 (61.63)
Platelets, Week 20, n=274, 297	Number Analyzed	274 participants	297 participants
		226.5 (58.11)	237.7 (61.51)
Platelets, Week 24, n=279, 292	Number Analyzed	279 participants	292 participants
		224.9 (53.19)	239.8 (64.11)
Platelets, Week 28, n=268, 295	Number Analyzed	268 participants	295 participants
		224.7 (54.15)	239.0 (62.32)
Platelets, Week 32, n=267, 289	Number Analyzed	267 participants	289 participants
		226.5 (50.84)	239.3 (59.53)
Platelets, Week 36, n=267, 284	Number Analyzed	267 participants	284 participants
		229.0 (53.90)	242.9 (66.12)
Platelets, Week 40, n=263, 288	Number Analyzed	263 participants	288 participants
		230.1 (53.48)	240.8 (61.92)
Platelets, Week 44, n=270, 286	Number Analyzed	270 participants	286 participants
		235.5 (55.80)	241.4 (61.73)
Platelets, Week 48, n=253, 281	Number Analyzed	253 participants	281 participants
		230.5 (54.33)	240.2 (62.95)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:		During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed		308	308
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liters
Basophils, Week 4, n=299, 290	Number Analyzed	299 participants	290 participants
		0.003 (0.0202)	0.003 (0.0185)
Basophils, Week 8, n=216, 293	Number Analyzed	216 participants	293 participants
		0.003 (0.0204)	0.000 (0.0181)
Basophils, Week 12, n=293, 289	Number Analyzed	293 participants	289 participants
		0.002 (0.0205)	0.001 (0.0197)
Basophils, Week 16, n=274, 291	Number Analyzed	274 participants	291 participants
		0.001 (0.0186)	0.001 (0.0181)
Basophils, Week 20, n=273, 291	Number Analyzed	273 participants	291 participants
		0.002 (0.0225)	0.002 (0.0212)
Basophils, Week 24, n=277, 291	Number Analyzed	277 participants	291 participants
		0.002 (0.0169)	0.003 (0.0167)
Basophils, Week 28, n=266, 294	Number Analyzed	266 participants	294 participants
		0.003 (0.0200)	0.002 (0.0181)
Basophils, Week 32, n=262, 282	Number Analyzed	262 participants	282 participants
		0.005 (0.0199)	0.003 (0.0189)
Basophils, Week 36, n=260, 281	Number Analyzed	260 participants	281 participants
		0.009 (0.0231)	0.007 (0.0217)
Basophils, Week 40, n=258, 279	Number Analyzed	258 participants	279 participants
		0.014 (0.0292)	0.011 (0.0233)
Basophils, Week 44, n=258, 267	Number Analyzed	258 participants	267 participants
		0.017 (0.0283)	0.012 (0.0239)
Basophils, Week 48, n=246, 273	Number Analyzed	246 participants	273 participants
		0.019 (0.0273)	0.018 (0.0263)
Eosinophils, Week 4, n=299, 290	Number Analyzed	299 participants	290 participants
		0.026 (0.1394)	0.009 (0.1409)
Eosinophils, Week 8, n=216, 293	Number Analyzed	216 participants	293 participants
		0.015 (0.1278)	-0.008 (0.1319)
Eosinophils, Week 12, n=293, 289	Number Analyzed	293 participants	289 participants
		-0.003 (0.1155)	-0.010 (0.1533)
Eosinophils, Week 16, n=274, 291	Number Analyzed	274 participants	291 participants
		0.009 (0.1246)	-0.011 (0.1759)
Eosinophils, Week 20, n=273, 291	Number Analyzed	273 participants	291 participants
		0.009 (0.1410)	-0.027 (0.1352)
Eosinophils, Week 24, n=277, 291	Number Analyzed	277 participants	291 participants
		0.002 (0.1228)	-0.021 (0.1490)
Eosinophils, Week 28, n=266, 294	Number Analyzed	266 participants	294 participants
		-0.002 (0.1298)	-0.011 (0.1387)
Eosinophils, Week 32, n=262, 282	Number Analyzed	262 participants	282 participants
		0.022 (0.1629)	-0.012 (0.1511)
Eosinophils, Week 36, n=260, 281	Number Analyzed	260 participants	281 participants
		0.002 (0.1413)	-0.012 (0.1382)
Eosinophils, Week 40, n=258, 279	Number Analyzed	258 participants	279 participants
		0.019 (0.1319)	-0.006 (0.1283)
Eosinophils, Week 44, n=258, 267	Number Analyzed	258 participants	267 participants
		0.032 (0.1388)	-0.004 (0.1061)
Eosinophils, Week 48, n=246, 273	Number Analyzed	246 participants	273 participants
		0.032 (0.1321)	0.002 (0.1253)
Leukocytes, Week 4, n=300, 297	Number Analyzed	300 participants	297 participants
		0.54 (1.599)	0.13 (1.544)
Leukocytes, Week 8, n=217, 300	Number Analyzed	217 participants	300 participants
		0.19 (1.579)	-0.02 (1.548)
Leukocytes, Week 12, n=294, 292	Number Analyzed	294 participants	292 participants
		0.35 (1.743)	0.10 (1.571)
Leukocytes, Week 16, n=279, 294	Number Analyzed	279 participants	294 participants
		0.34 (1.653)	0.17 (1.558)
Leukocytes, Week 20, n=276, 297	Number Analyzed	276 participants	297 participants
		0.46 (1.565)	0.04 (1.529)
Leukocytes, Week 24, n=279, 293	Number Analyzed	279 participants	293 participants
		0.32 (1.720)	0.10 (1.661)
Leukocytes, Week 28, n=268, 296	Number Analyzed	268 participants	296 participants
		0.25 (1.651)	0.07 (1.471)
Leukocytes, Week 32, n=267, 287	Number Analyzed	267 participants	287 participants
		0.43 (1.602)	0.07 (1.631)
Leukocytes, Week 36, n=264, 284	Number Analyzed	264 participants	284 participants
		0.33 (1.699)	0.13 (1.821)
Leukocytes, Week 40, n=264, 285	Number Analyzed	264 participants	285 participants
		0.35 (1.808)	0.12 (1.675)
Leukocytes, Week 44, n=269, 278	Number Analyzed	269 participants	278 participants
		0.22 (1.581)	-0.03 (1.561)
Leukocytes, Week 48, n=252, 281	Number Analyzed	252 participants	281 participants
		0.09 (1.646)	-0.06 (1.538)
Lymphocytes, Week 4, n=299, 290	Number Analyzed	299 participants	290 participants
		0.174 (0.5185)	0.128 (0.5618)
Lymphocytes, Week 8, n=216, 293	Number Analyzed	216 participants	293 participants
		0.068 (0.5319)	0.023 (0.5250)
Lymphocytes, Week 12, n=293, 289	Number Analyzed	293 participants	289 participants
		0.033 (0.5073)	0.079 (0.5844)
Lymphocytes, Week 16, n=274, 291	Number Analyzed	274 participants	291 participants
		0.114 (0.5596)	0.095 (0.5389)
Lymphocytes, Week 20, n=273, 291	Number Analyzed	273 participants	291 participants
		0.071 (0.5274)	0.086 (0.5411)
Lymphocytes, Week 24, n=277, 291	Number Analyzed	277 participants	291 participants
		0.079 (0.5408)	0.049 (0.4863)
Lymphocytes, Week 28, n=266, 294	Number Analyzed	266 participants	294 participants
		0.101 (0.6133)	0.069 (0.6005)
Lymphocytes, Week 32, n=262, 282	Number Analyzed	262 participants	282 participants
		0.063 (0.5392)	0.064 (0.5757)
Lymphocytes, Week 36, n=260, 281	Number Analyzed	260 participants	281 participants
		0.008 (0.5333)	0.036 (0.5525)
Lymphocytes, Week 40, n=258, 279	Number Analyzed	258 participants	279 participants
		0.020 (0.5171)	0.035 (0.5280)
Lymphocytes, Week 44, n=258, 267	Number Analyzed	258 participants	267 participants
		0.045 (0.5430)	0.045 (0.5472)
Lymphocytes, Week 48, n=246, 273	Number Analyzed	246 participants	273 participants
		-0.063 (0.5528)	-0.035 (0.5115)
Neutrophils, Week 4, n=299, 290	Number Analyzed	299 participants	290 participants
		0.258 (1.5445)	0.004 (1.3601)
Neutrophils, Week 8, n=216, 293	Number Analyzed	216 participants	293 participants
		0.080 (1.4401)	-0.031 (1.3599)
Neutrophils, Week 12, n=293, 289	Number Analyzed	293 participants	289 participants
		0.283 (1.6227)	0.028 (1.3884)
Neutrophils, Week 16, n=274, 291	Number Analyzed	274 participants	291 participants
		0.181 (1.5415)	0.080 (1.4451)
Neutrophils, Week 20, n=273, 291	Number Analyzed	273 participants	291 participants
		0.341 (1.4475)	-0.019 (1.4228)
Neutrophils, Week 24, n=277, 291	Number Analyzed	277 participants	291 participants
		0.175 (1.5883)	0.056 (1.5091)
Neutrophils, Week 28, n=266, 294	Number Analyzed	266 participants	294 participants
		0.129 (1.4052)	-0.001 (1.3377)
Neutrophils, Week 32, n=262, 282	Number Analyzed	262 participants	282 participants
		0.291 (1.6015)	0.008 (1.4430)
Neutrophils, Week 36, n=260, 281	Number Analyzed	260 participants	281 participants
		0.289 (1.5702)	0.077 (1.6758)
Neutrophils, Week 40, n=258, 279	Number Analyzed	258 participants	279 participants
		0.245 (1.6621)	0.075 (1.5336)
Neutrophils, Week 44, n=258, 267	Number Analyzed	258 participants	267 participants
		0.063 (1.4874)	-0.105 (1.4587)
Neutrophils, Week 48, n=246, 273	Number Analyzed	246 participants	273 participants
		0.009 (1.5413)	-0.066 (1.3969)
Monocytes, Week 4, n=299, 290	Number Analyzed	299 participants	290 participants
		0.049 (0.1663)	0.030 (0.1270)
Monocytes Week 8, n=216, 293	Number Analyzed	216 participants	293 participants
		0.014 (0.1433)	0.018 (0.1591)
Monocytes, Week 12, n=293, 289	Number Analyzed	293 participants	289 participants
		0.018 (0.1553)	0.001 (0.1367)
Monocytes, Week 16, n=274, 291	Number Analyzed	274 participants	291 participants
		0.005 (0.1588)	0.003 (0.1403)
Monocytes, Week 20, n=273, 291	Number Analyzed	273 participants	291 participants
		0.003 (0.1527)	0.004 (0.1328)
Monocytes, Week 24, n=277, 291	Number Analyzed	277 participants	291 participants
		0.012 (0.1484)	0.002 (0.1331)
Monocytes, Week 28, n=266, 294	Number Analyzed	266 participants	294 participants
		0.001 (0.1548)	-0.004 (0.1343)
Monocytes, Week 32, n=262, 282	Number Analyzed	262 participants	282 participants
		0.019 (0.1535)	0.011 (0.1585)
Monocytes, Week 36, n=260, 281	Number Analyzed	260 participants	281 participants
		0.016 (0.1501)	0.024 (0.1551)
Monocytes, Week 40, n=258, 279	Number Analyzed	258 participants	279 participants
		0.039 (0.1507)	0.020 (0.1550)
Monocytes, Week 44, n=258, 267	Number Analyzed	258 participants	267 participants
		0.045 (0.1673)	0.045 (0.1539)
Monocytes, Week 48, n=246, 273	Number Analyzed	246 participants	273 participants
		0.047 (0.1502)	0.039 (0.1499)
Platelets, Week 4, n=300, 298	Number Analyzed	300 participants	298 participants
		1.8 (38.02)	4.3 (36.15)
Platelets, Week 8, n=216, 298	Number Analyzed	216 participants	298 participants
		-5.5 (31.98)	0.7 (35.15)
Platelets, Week 12, n=294, 290	Number Analyzed	294 participants	290 participants
		-0.8 (40.83)	5.5 (36.76)
Platelets, Week 16, n=279, 294	Number Analyzed	279 participants	294 participants
		-5.2 (40.67)	4.3 (34.61)
Platelets, Week 20, n=274, 297	Number Analyzed	274 participants	297 participants
		-3.7 (36.87)	5.5 (38.86)
Platelets, Week 24, n=279, 292	Number Analyzed	279 participants	292 participants
		-4.7 (35.22)	6.7 (41.78)
Platelets, Week 28, n=268, 295	Number Analyzed	268 participants	295 participants
		-5.3 (35.22)	5.4 (38.41)
Platelets, Week 32, n=267, 289	Number Analyzed	267 participants	289 participants
		-2.6 (36.51)	6.5 (35.99)
Platelets, Week 36, n=267, 284	Number Analyzed	267 participants	284 participants
		-1.2 (37.26)	9.8 (44.52)
Platelets, Week 40, n=263, 288	Number Analyzed	263 participants	288 participants
		0.0 (40.74)	9.7 (39.91)
Platelets, Week 44, n=270, 286	Number Analyzed	270 participants	286 participants
		4.5 (38.31)	9.2 (42.82)
Platelets, Week 48, n=253, 281	Number Analyzed	253 participants	281 participants
		0.0 (38.63)	10.4 (41.75)

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

21. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

22. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

23. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

24. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

25. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

26. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

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

28. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:		During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed		308	308
Measure Type: Count of Participants; Unit of Measure: Participants
Urine bilirubin,Baseline (Day 1),Trace, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine bilirubin, Baseline (Day 1), 1+, n=303, 301	Number Analyzed	303 participants	301 participants
		6 2.0%	7 2.3%
Urine bilirubin, Baseline (Day 1), 2+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine bilirubin, Baseline (Day 1), 3+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine glucose, Baseline (Day 1), Trace, n=303, 301	Number Analyzed	303 participants	301 participants
		1 0.3%	1 0.3%
Urine glucose, Baseline (Day 1), 1+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	1 0.3%
Urine glucose, Baseline (Day 1), 2+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine glucose, Baseline (Day 1), 3+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	1 0.3%
Urine ketones, Baseline (Day 1), Trace, n=303, 301	Number Analyzed	303 participants	301 participants
		16 5.3%	17 5.6%
Urine ketones, Baseline (Day 1), 1+, n=303, 301	Number Analyzed	303 participants	301 participants
		4 1.3%	0 0.0%
Urine ketones, Baseline (Day 1), 2+, n=303, 301	Number Analyzed	303 participants	301 participants
		2 0.7%	1 0.3%
Urine ketones, Baseline (Day 1), 3+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine leukocyte esterase,Baseline,Trace,n=303,301	Number Analyzed	303 participants	301 participants
		25 8.3%	18 6.0%
Urine leukocyte esterase, Baseline, 1+, n=303, 301	Number Analyzed	303 participants	301 participants
		14 4.6%	16 5.3%
Urine leukocyte esterase, Baseline, 2+, n=303, 301	Number Analyzed	303 participants	301 participants
		14 4.6%	8 2.7%
Urine leukocyte esterase, Baseline, 3+, n=303, 301	Number Analyzed	303 participants	301 participants
		5 1.7%	5 1.7%
Urine nitrite, Baseline, positive, n=303, 301	Number Analyzed	303 participants	301 participants
		11 3.6%	11 3.7%
Urine occult blood, Baseline, Trace, n=303, 301	Number Analyzed	303 participants	301 participants
		19 6.3%	12 4.0%
Urine occult blood, Baseline, 1+, n=303, 301	Number Analyzed	303 participants	301 participants
		8 2.6%	9 3.0%
Urine occult blood, Baseline, 2+, n=303, 301	Number Analyzed	303 participants	301 participants
		7 2.3%	5 1.7%
Urine occult blood, Baseline, 3+, n=303, 301	Number Analyzed	303 participants	301 participants
		5 1.7%	3 1.0%
Urine protein, Baseline, Trace, n=303, 301	Number Analyzed	303 participants	301 participants
		14 4.6%	20 6.6%
Urine protein, Baseline, 1+, n=303, 301	Number Analyzed	303 participants	301 participants
		6 2.0%	12 4.0%
Urine protein, Baseline, 2+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	1 0.3%
Urine protein, Baseline, 3+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine protein, Baseline, 4+, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 4, Trace, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 4, 1+, n=303, 302	Number Analyzed	303 participants	302 participants
		9 3.0%	5 1.7%
Urine bilirubin, Week 4, 2+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 4, 3+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	0 0.0%
Urine glucose, Week 4, Trace, n=303, 302	Number Analyzed	303 participants	302 participants
		3 1.0%	2 0.7%
Urine glucose, Week 4, 1+, n=303, 302	Number Analyzed	303 participants	302 participants
		1 0.3%	2 0.7%
Urine glucose, Week 4, 2+, n=303, 302	Number Analyzed	303 participants	302 participants
		2 0.7%	0 0.0%
Urine glucose, Week 4, 3+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	1 0.3%
Urine ketones, Week 4, Trace, n=303, 302	Number Analyzed	303 participants	302 participants
		9 3.0%	15 5.0%
Urine ketones, Week 4, 1+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	2 0.7%
Urine ketones, Week 4, 2+, n=303, 302	Number Analyzed	303 participants	302 participants
		1 0.3%	1 0.3%
Urine ketones, Week 4, 3+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	0 0.0%
Urine leukocyte esterase, Week 4, Trace,n=303, 302	Number Analyzed	303 participants	302 participants
		25 8.3%	29 9.6%
Urine leukocyte esterase, Week 4, 1+, n=303, 302	Number Analyzed	303 participants	302 participants
		14 4.6%	15 5.0%
Urine leukocyte esterase, Week 4, 2+, n=303, 302	Number Analyzed	303 participants	302 participants
		14 4.6%	9 3.0%
Urine leukocyte esterase, Week 4, 3+, n=303, 302	Number Analyzed	303 participants	302 participants
		3 1.0%	4 1.3%
Urine nitrite, Week 4, positive, n=303, 302	Number Analyzed	303 participants	302 participants
		10 3.3%	12 4.0%
Urine occult blood, Week 4, Trace, n=303, 302	Number Analyzed	303 participants	302 participants
		15 5.0%	18 6.0%
Urine occult blood, Week 4, 1+, n=303, 302	Number Analyzed	303 participants	302 participants
		9 3.0%	10 3.3%
Urine occult blood, Week 4, 2+, n=303, 302	Number Analyzed	303 participants	302 participants
		5 1.7%	5 1.7%
Urine occult blood, Week 4, 3+, n=303, 302	Number Analyzed	303 participants	302 participants
		4 1.3%	3 1.0%
Urine protein, Week 4, Trace, n=303, 302	Number Analyzed	303 participants	302 participants
		10 3.3%	13 4.3%
Urine protein, Week 4, 1+, n=303, 302	Number Analyzed	303 participants	302 participants
		8 2.6%	7 2.3%
Urine protein, Week 4, 2+, n=303, 302	Number Analyzed	303 participants	302 participants
		2 0.7%	4 1.3%
Urine protein, Week 4, 3+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	0 0.0%
Urine protein, Week 4, 4+, n=303, 302	Number Analyzed	303 participants	302 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 24, Trace, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 24, 1+, n=279, 298	Number Analyzed	279 participants	298 participants
		10 3.6%	13 4.4%
Urine bilirubin, Week 24, 2+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 24, 3+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine glucose, Week 24, Trace, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	1 0.3%
Urine glucose, Week 24, 1+, n=279, 298	Number Analyzed	279 participants	298 participants
		2 0.7%	0 0.0%
Urine glucose, Week 24, 2+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	1 0.3%
Urine glucose, Week 24, 3+, n=279, 298	Number Analyzed	279 participants	298 participants
		1 0.4%	1 0.3%
Urine ketones, Week 24, Trace, n=279, 298	Number Analyzed	279 participants	298 participants
		16 5.7%	13 4.4%
Urine ketones, Week 24, 1+, n=279, 298	Number Analyzed	279 participants	298 participants
		1 0.4%	1 0.3%
Urine ketones, Week 24, 2+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine ketones, Week 24, 3+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine leukocyte esterase,Week 24, Trace, n=279,298	Number Analyzed	279 participants	298 participants
		22 7.9%	17 5.7%
Urine leukocyte esterase, Week 24, 1+, n=279, 298	Number Analyzed	279 participants	298 participants
		14 5.0%	14 4.7%
Urine leukocyte esterase, Week 24, 2+, n=279, 298	Number Analyzed	279 participants	298 participants
		6 2.2%	14 4.7%
Urine leukocyte esterase, Week 24, 3+, n=279, 298	Number Analyzed	279 participants	298 participants
		3 1.1%	7 2.3%
Urine nitrite, Week 24, positive, n=279, 298	Number Analyzed	279 participants	298 participants
		9 3.2%	10 3.4%
Urine occult blood, Week 24, Trace, n=279, 298	Number Analyzed	279 participants	298 participants
		13 4.7%	10 3.4%
Urine occult blood, Week 24, 1+, n=279, 298	Number Analyzed	279 participants	298 participants
		5 1.8%	6 2.0%
Urine occult blood, Week 24, 2+, n=279, 298	Number Analyzed	279 participants	298 participants
		6 2.2%	4 1.3%
Urine occult blood, Week 24, 3+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	6 2.0%
Urine protein, Week 24, Trace, n=279, 298	Number Analyzed	279 participants	298 participants
		10 3.6%	21 7.0%
Urine protein, Week 24, 1+, n=279, 298	Number Analyzed	279 participants	298 participants
		4 1.4%	12 4.0%
Urine protein, Week 24, 2+, n=279, 298	Number Analyzed	279 participants	298 participants
		1 0.4%	3 1.0%
Urine protein, Week 24, 3+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine protein, Week 24, 4+, n=279, 298	Number Analyzed	279 participants	298 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 48, Trace, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	0 0.0%
Urine bilirubin, Week 48, 1+, n=279, 290	Number Analyzed	279 participants	290 participants
		9 3.2%	8 2.8%
Urine bilirubin, Week 48, 2+, n=279, 290	Number Analyzed	279 participants	290 participants
		1 0.4%	0 0.0%
Urine bilirubin, Week 48, 3+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	0 0.0%
Urine glucose, Week 48, Trace, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	1 0.3%
Urine glucose, Week 48, 1+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	2 0.7%
Urine glucose, Week 48, 2+, n=279, 290	Number Analyzed	279 participants	290 participants
		1 0.4%	0 0.0%
Urine glucose, Week 48, 3+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	2 0.7%
Urine ketones, Week 48, Trace, n=279, 290	Number Analyzed	279 participants	290 participants
		13 4.7%	9 3.1%
Urine ketones, Week 48, 1+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	0 0.0%
Urine ketones, Week 48, 2+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	0 0.0%
Urine ketones, Week 48, 3+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	0 0.0%
Urine leukocyte esterase, Week 48, Trace,n=279,290	Number Analyzed	279 participants	290 participants
		24 8.6%	27 9.3%
Urine leukocyte esterase, Week 48, 1+, n=279, 290	Number Analyzed	279 participants	290 participants
		13 4.7%	15 5.2%
Urine leukocyte esterase, Week 48, 2+, n=279, 290	Number Analyzed	279 participants	290 participants
		7 2.5%	7 2.4%
Urine leukocyte esterase, Week 48, 3+, n=279, 290	Number Analyzed	279 participants	290 participants
		5 1.8%	6 2.1%
Urine nitrite, Week 48, positive, n=279, 290	Number Analyzed	279 participants	290 participants
		10 3.6%	6 2.1%
Urine occult blood, Week 48, Trace, n=279, 290	Number Analyzed	279 participants	290 participants
		11 3.9%	12 4.1%
Urine occult blood, Week 48, 1+, n=279, 290	Number Analyzed	279 participants	290 participants
		5 1.8%	5 1.7%
Urine occult blood, Week 48, 2+, n=279, 290	Number Analyzed	279 participants	290 participants
		4 1.4%	4 1.4%
Urine occult blood, Week 48, 3+, n=279, 290	Number Analyzed	279 participants	290 participants
		6 2.2%	0 0.0%
Urine protein, Week 48, Trace, n=279, 290	Number Analyzed	279 participants	290 participants
		10 3.6%	15 5.2%
Urine protein, Week 48, 1+, n=279, 290	Number Analyzed	279 participants	290 participants
		4 1.4%	6 2.1%
Urine protein, Week 48, 2+, n=279, 290	Number Analyzed	279 participants	290 participants
		3 1.1%	3 1.0%
Urine protein, Week 48, 3+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	0 0.0%
Urine protein, Week 48, 4+, n=279, 290	Number Analyzed	279 participants	290 participants
		0 0.0%	1 0.3%

29. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		CAB LA+RPV LA (Q4W)	Current ART
Arm/Group Description:		During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period	During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
Overall Number of Participants Analyzed		308	308
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline, pH=5, n=303, 301	Number Analyzed	303 participants	301 participants
		44 14.5%	42 14.0%
Baseline, pH=5.5, n=303, 301	Number Analyzed	303 participants	301 participants
		78 25.7%	80 26.6%
Baseline, pH=6, n=303, 301	Number Analyzed	303 participants	301 participants
		85 28.1%	72 23.9%
Baseline, pH=6.5, n=303, 301	Number Analyzed	303 participants	301 participants
		47 15.5%	45 15.0%
Baseline, pH=7, n=303, 301	Number Analyzed	303 participants	301 participants
		32 10.6%	34 11.3%
Baseline, pH=7.5, n=303, 301	Number Analyzed	303 participants	301 participants
		12 4.0%	19 6.3%
Baseline, pH=8, n=303, 301	Number Analyzed	303 participants	301 participants
		3 1.0%	7 2.3%
Baseline, pH=8.5, n=303, 301	Number Analyzed	303 participants	301 participants
		0 0.0%	1 0.3%
Baseline, pH>9.0, n=303, 301	Number Analyzed	303 participants	301 participants
		2 0.7%	1 0.3%
Week 4, pH=5, n=303, 302	Number Analyzed	303 participants	302 participants
		41 13.5%	53 17.5%
Week 4, pH=5.5, n=303, 302	Number Analyzed	303 participants	302 participants
		78 25.7%	93 30.8%
Week 4, pH=6, n=303, 302	Number Analyzed	303 participants	302 participants
		73 24.1%	67 22.2%
Week 4, pH=6.5, n=303, 302	Number Analyzed	303 participants	302 participants
		49 16.2%	41 13.6%
Week 4, pH=7, n=303, 302	Number Analyzed	303 participants	302 participants
		38 12.5%	28 9.3%
Week 4, pH=7.5, n=303, 302	Number Analyzed	303 participants	302 participants
		12 4.0%	14 4.6%
Week 4, pH=8, n=303, 302	Number Analyzed	303 participants	302 participants
		8 2.6%	3 1.0%
Week 4, pH=8.5, n=303, 302	Number Analyzed	303 participants	302 participants
		3 1.0%	2 0.7%
Week 4, pH>9.0, n=303, 302	Number Analyzed	303 participants	302 participants
		1 0.3%	1 0.3%
Week 24, pH=5, n=279, 298	Number Analyzed	279 participants	298 participants
		23 8.2%	26 8.7%
Week 24, pH=5.5, n=279, 298	Number Analyzed	279 participants	298 participants
		85 30.5%	96 32.2%
Week 24, pH=6, n=279, 298	Number Analyzed	279 participants	298 participants
		66 23.7%	67 22.5%
Week 24, pH=6.5, n=279, 298	Number Analyzed	279 participants	298 participants
		44 15.8%	52 17.4%
Week 24, pH=7, n=279, 298	Number Analyzed	279 participants	298 participants
		32 11.5%	31 10.4%
Week 24, pH=7.5, n=279, 298	Number Analyzed