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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

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ClinicalTrials.gov Identifier: NCT02951052
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Results First Posted : June 13, 2019
Last Update Posted : November 19, 2019
Sponsor:
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
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
Hide 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 Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period During Maintenance phase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
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART Total
Hide 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
Hide 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%
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART
Hide 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
Hide Description Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Time Frame Week 48
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title CAB LA+RPV LA (Q4W) Current ART
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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