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Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02938520
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Results First Posted : October 29, 2019
Last Update Posted : March 23, 2020
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
Condition HIV Infections
Interventions Drug: Cabotegravir (CAB) tablet
Drug: Rilpivirine (RPV) tablet
Drug: Cabotegravir - Injectable Suspension (CAB LA)
Drug: Rilpivirine - Injectable Suspension (RPV LA)
Drug: ABC/DTG/3TC STR - Tablet
Drug: DTG Tablet
Enrollment 631
Recruitment Details This non-inferiority study evaluated antiviral activity of switching to intramuscular long acting carbotegravir (CAB) and rilpivirine (RPV) every 4 weeks compared to continuation of abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection
Pre-assignment Details A total of 631 participants were enrolled into the Induction Phase of the study. 566 participants were subsequently randomized. Two randomized participants did not receive study treatment. This study was conducted in 11 countries. The results presented are based on Week 48 primary analysis
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period. During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Period Title: Overall Study
Started 283 283
Completed 0 0
Not Completed 283 283
Reason Not Completed
On-going at the time of analysis             258             261
Physician Decision             2             5
Lost to Follow-up             2             2
Withdrawal by Subject             7             7
Protocol Violation             0             1
Lack of Efficacy             5             3
Adverse Event             9             4
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC Total
Hide Arm/Group Description Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period. During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA Total of all reporting groups
Overall Number of Baseline Participants 283 283 566
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 283 participants 566 participants
35.9  (10.17) 36.0  (9.82) 35.9  (9.99)
[1]
Measure Description: Intent-to-Treat Exposed
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Female
63
  22.3%
64
  22.6%
127
  22.4%
Male
220
  77.7%
219
  77.4%
439
  77.6%
[1]
Measure Description: Intent-to-Treat Exposed
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
American Indian or Alaska Native 3 6 9
Asian-Central/South Asian Heritage 2 1 3
Asian-East Asian Heritage 1 2 3
Asian-South East Asian Heritage 1 0 1
Asian-Japanese Heritage 8 12 20
Black or African American 47 56 103
Native Hawaiian or other Pacific Islander 1 0 1
White-Arabic/North African Heritage 5 3 8
White-White /Caucasian/European Heritage 211 198 409
Multiple 4 3 7
Missing 0 2 2
1.Primary Outcome
Title Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
Hide Description Percentage 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 noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event).
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Number
Unit of Measure: Percentage of Participants
2.1 2.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB LA + RPV LA (Q4W), ABC/ DTG/ 3TC
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 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB – ABC/DTG/3TC) is less than 6%.
Method of Estimation Estimation Parameter Adjusted difference in proportion
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.8 to 2.1
Estimation Comments [Not Specified]
Other Statistical Analysis 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 Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48
Hide Description Percentage 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 ABC/DTG/3TC. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Number
Unit of Measure: Percentage of Participants
94 93
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB LA + RPV LA (Q4W), ABC/ DTG/ 3TC
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 – ABC/DTG/3TC) is more than -10%
Method of Estimation Estimation Parameter Adjusted difference in proportion
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-3.7 to 4.5
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 Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)
3.Secondary Outcome
Title Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48
Hide Description Percentage 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 ABC/DTG/3TC
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
94
(91 to 97)
94
(91 to 97)
4.Secondary Outcome
Title Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase
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.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.4%
3
   1.1%
5.Secondary Outcome
Title Absolute Values for Plasma HIV-1 RNA at Week 48
Hide Description Plasma for quantitative HIV-1 RNA were collected at indicated time points. 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.513  (0.0954) 1.518  (0.1152)
6.Secondary Outcome
Title Change From Baseline Values for Plasma HIV-1 RNA at Week 48
Hide Description Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline.
Time Frame Baseline (Day 1) and at 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-0.006  (0.1026) 0.001  (0.1435)
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 ABC/DTG/3TC
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
703.2  (285.75) 731.2  (272.49)
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 ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
40.2  (195.17) 79.9  (194.55)
9.Secondary Outcome
Title Number of Participants With Disease Progression
Hide Description Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).
Time Frame Day 1 up to an average of 59 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
9
   3.2%
11
   3.9%
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 temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is 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 judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in >=5% of participants within any arm is reported
Time Frame Day 1 up to an average of 59 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
Any non-SAE
252
  89.0%
138
  48.8%
Any SAE
18
   6.4%
12
   4.2%
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 acquired immuno deficiency syndrome (DAIDS) 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. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title CAB LA + RPV LA (Q4W) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
93
  32.9%
119
  42.0%
Grade 2
143
  50.5%
95
  33.6%
Grade 3
23
   8.1%
10
   3.5%
Grade 4
8
   2.8%
1
   0.4%
Grade 5
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per Liter
Basophils, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
0.022  (0.0124) 0.022  (0.0138)
Basophils, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.024  (0.0136) 0.024  (0.0142)
Basophils, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.023  (0.0135) 0.023  (0.0122)
Basophils, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.025  (0.0166) 0.023  (0.0144)
Basophils, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.030  (0.0212) 0.028  (0.0209)
Basophils, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.035  (0.0254) 0.032  (0.0256)
Basophils, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.037  (0.0245) 0.036  (0.0256)
Basophils, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.039  (0.0249) 0.038  (0.0247)
Basophils, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.044  (0.0254) 0.038  (0.0246)
Basophils, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.042  (0.0237) 0.040  (0.0250)
Basophils, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.041  (0.0248) 0.041  (0.0252)
Basophils, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.040  (0.0246) 0.040  (0.0257)
Basophils, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.038  (0.0214) 0.038  (0.0246)
Eosinophils, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
0.142  (0.1238) 0.141  (0.1449)
Eosinophils, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.164  (0.1470) 0.154  (0.1535)
Eosinophils, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.169  (0.1401) 0.150  (0.1393)
Eosinophils, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.165  (0.1375) 0.157  (0.1481)
Eosinophils, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.177  (0.1538) 0.162  (0.1434)
Eosinophils, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.185  (0.1617) 0.166  (0.1675)
Eosinophils, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.193  (0.1591) 0.172  (0.1518)
Eosinophils, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.206  (0.1634) 0.179  (0.1659)
Eosinophils, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.206  (0.1779) 0.169  (0.1466)
Eosinophils, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.209  (0.2043) 0.172  (0.1540)
Eosinophils, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.203  (0.1837) 0.174  (0.1495)
Eosinophils, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.198  (0.1867) 0.180  (0.1723)
Eosinophils, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.182  (0.1508) 0.172  (0.1533)
Leukocytes, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
5.82  (1.792) 5.68  (1.684)
Leukocytes, Week 4, n=279, 272 Number Analyzed 279 participants 272 participants
6.41  (1.989) 6.11  (1.770)
Leukocytes, Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
6.04  (1.806) 6.00  (1.714)
Leukocytes, Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
5.88  (1.590) 6.08  (1.836)
Leukocytes, Week 16, n=252, 265 Number Analyzed 252 participants 265 participants
6.08  (2.045) 6.11  (1.887)
Leukocytes, Week 20, n=254, 265 Number Analyzed 254 participants 265 participants
6.08  (1.788) 6.15  (1.926)
Leukocytes, Week 24, n=258, 264 Number Analyzed 258 participants 264 participants
6.11  (1.841) 6.16  (2.046)
Leukocytes, Week 28, n=244, 263 Number Analyzed 244 participants 263 participants
6.17  (1.929) 6.17  (1.939)
Leukocytes, Week 32, n=253, 266 Number Analyzed 253 participants 266 participants
6.07  (1.925) 6.12  (1.918)
Leukocytes, Week 36, n=252, 259 Number Analyzed 252 participants 259 participants
6.11  (1.992) 6.23  (2.104)
Leukocytes, Week 40, n=246, 253 Number Analyzed 246 participants 253 participants
5.96  (1.773) 6.12  (2.076)
Leukocytes, Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
6.03  (2.000) 6.19  (1.970)
Leukocytes, Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
5.85  (1.884) 5.99  (1.986)
Lymphocytes, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
2.022  (0.6893) 1.957  (0.6408)
Lymphocytes, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
2.227  (0.7321) 2.197  (0.7198)
Lymphocytes, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
2.102  (0.6980) 2.110  (0.7015)
Lymphocytes, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
2.032  (0.6095) 2.117  (0.7162)
Lymphocytes, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
2.028  (0.6931) 2.130  (0.7245)
Lymphocytes, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
2.028  (0.6284) 2.121  (0.6995)
Lymphocytes, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
2.014  (0.6456) 2.111  (0.7092)
Lymphocytes, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
2.051  (0.6592) 2.106  (0.6679)
Lymphocytes, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
2.037  (0.6543) 2.112  (0.6950)
Lymphocytes, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
2.023  (0.6878) 2.098  (0.6921)
Lymphocytes, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
2.021  (0.6646) 2.030  (0.6357)
Lymphocytes, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
1.997  (0.6748) 2.068  (0.6754)
Lymphocytes, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
1.926  (0.6126) 2.003  (0.7651)
Monocytes, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
0.382  (0.1666) 0.366  (0.1705)
Monocytes, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.422  (0.1778) 0.398  (0.1778)
Monocytes, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.415  (0.1824) 0.380  (0.1771)
Monocytes, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.395  (0.1662) 0.383  (0.1570)
Monocytes, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.438  (0.1859) 0.409  (0.1810)
Monocytes, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.455  (0.1927) 0.423  (0.1904)
Monocytes, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.438  (0.1859) 0.438  (0.1897)
Monocytes, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.471  (0.1916) 0.447  (0.2003)
Monocytes, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.462  (0.1898) 0.459  (0.2107)
Monocytes, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.458  (0.2116) 0.456  (0.2021)
Monocytes, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.438  (0.1740) 0.442  (0.2038)
Monocytes, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.440  (0.1907) 0.428  (0.1965)
Monocytes, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.402  (0.1911) 0.396  (0.1857)
Neutrophils, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
3.246  (1.3715) 3.205  (1.2803)
Neutrophils, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
3.573  (1.5681) 3.342  (1.3344)
Neutrophils, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
3.334  (1.3166) 3.316  (1.3588)
Neutrophils, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
3.271  (1.2151) 3.379  (1.4884)
Neutrophils, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
3.410  (1.7208) 3.432  (1.5052)
Neutrophils, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
3.406  (1.4209) 3.433  (1.5620)
Neutrophils, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
3.428  (1.4938) 3.424  (1.6766)
Neutrophils, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
3.439  (1.5379) 3.423  (1.5514)
Neutrophils, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
3.367  (1.5670) 3.392  (1.4892)
Neutrophils, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
3.388  (1.5215) 3.468  (1.6269)
Neutrophils, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
3.274  (1.3654) 3.477  (1.7021)
Neutrophils, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
3.398  (1.5679) 3.503  (1.5486)
Neutrophils, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
3.309  (1.4923) 3.419  (1.5186)
Platelets, Baseline (Day 1), n=283, 282 Number Analyzed 283 participants 282 participants
226.7  (55.39) 230.6  (58.33)
Platelets, Week 4, n=278, 269 Number Analyzed 278 participants 269 participants
233.1  (56.85) 233.4  (56.56)
Platelets, Week 8, n=207, 273 Number Analyzed 207 participants 273 participants
226.9  (53.23) 232.0  (56.31)
Platelets, Week 12, n=269, 271 Number Analyzed 269 participants 271 participants
226.6  (55.07) 235.5  (57.26)
Platelets, Week 16, n=251, 263 Number Analyzed 251 participants 263 participants
225.5  (55.49) 239.9  (70.40)
Platelets, Week 20, n=255, 264 Number Analyzed 255 participants 264 participants
233.8  (60.98) 243.4  (62.06)
Platelets, Week 24, n=256, 261 Number Analyzed 256 participants 261 participants
233.9  (58.12) 244.2  (59.95)
Platelets, Week 28, n=245, 258 Number Analyzed 245 participants 258 participants
233.7  (61.56) 247.2  (63.18)
Platelets, Week 32, n=249, 262 Number Analyzed 249 participants 262 participants
235.0  (62.74) 245.3  (60.25)
Platelets, Week 36, n=248, 259 Number Analyzed 248 participants 259 participants
237.3  (58.56) 248.1  (59.57)
Platelets, Week 40, n=244, 254 Number Analyzed 244 participants 254 participants
233.9  (56.93) 247.4  (63.85)
Platelets, Week 44, n=254, 261 Number Analyzed 254 participants 261 participants
236.7  (58.18) 249.5  (71.56)
Platelets, Week 48, n=240, 255 Number Analyzed 240 participants 255 participants
232.8  (57.07) 246.0  (70.35)
13.Secondary Outcome
Title Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume
Hide Description Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
94.8  (4.94) 94.3  (5.69)
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
94.1  (4.77) 94.6  (5.85)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
92.3  (4.86) 94.6  (5.78)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
91.0  (4.64) 94.0  (5.81)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
89.9  (4.43) 94.1  (5.78)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
89.3  (4.46) 93.9  (5.64)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
89.4  (4.33) 93.8  (5.69)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
89.3  (4.64) 93.5  (5.78)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
89.6  (4.69) 93.6  (5.90)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
89.5  (4.65) 94.1  (5.65)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
90.3  (4.62) 94.4  (6.09)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
90.7  (5.05) 94.6  (6.32)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
91.2  (5.21) 95.4  (6.60)
14.Secondary Outcome
Title Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes
Hide Description Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per Liter
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
4.59  (0.434) 4.65  (0.412)
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
4.67  (0.423) 4.62  (0.406)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
4.76  (0.435) 4.67  (0.410)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
4.82  (0.435) 4.66  (0.419)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
4.87  (0.430) 4.66  (0.407)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
4.89  (0.418) 4.64  (0.410)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
4.87  (0.418) 4.67  (0.425)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
4.87  (0.416) 4.69  (0.395)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
4.83  (0.435) 4.66  (0.418)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
4.82  (0.403) 4.64  (0.395)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
4.81  (0.407) 4.63  (0.409)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
4.79  (0.425) 4.59  (0.403)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
4.74  (0.443) 4.59  (0.437)
15.Secondary Outcome
Title Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin
Hide Description Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
142.5  (13.59) 143.1  (13.51)
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
144.3  (13.34) 143.4  (13.47)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
143.9  (13.84) 144.7  (13.59)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
144.5  (13.89) 144.7  (14.66)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
145.3  (13.52) 144.6  (13.88)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
145.4  (12.69) 144.8  (13.87)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
145.0  (13.14) 145.3  (14.07)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
145.3  (12.80) 146.5  (14.17)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
145.1  (13.37) 146.2  (14.80)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
144.6  (12.27) 146.2  (13.85)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
145.9  (12.32) 146.2  (13.85)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
145.1  (12.79) 145.0  (14.13)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
143.8  (13.56) 145.4  (14.56)
16.Secondary Outcome
Title Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit
Hide Description Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
0.4341  (0.03889) 0.4370  (0.03887)
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
0.4387  (0.03809) 0.4363  (0.03832)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
0.4382  (0.04056) 0.4403  (0.03978)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
0.4377  (0.04020) 0.4373  (0.04144)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
0.4366  (0.03769) 0.4371  (0.03890)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
0.4363  (0.03574) 0.4349  (0.03839)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
0.4351  (0.03580) 0.4366  (0.03901)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
0.4342  (0.03519) 0.4374  (0.03867)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
0.4318  (0.03623) 0.4347  (0.04025)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
0.4301  (0.03392) 0.4349  (0.03774)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
0.4328  (0.03433) 0.4358  (0.03845)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
0.4332  (0.03570) 0.4328  (0.03847)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
0.4310  (0.03875) 0.4361  (0.04156)
17.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 timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALT, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
28.7  (125.27) 19.5  (14.76)
ALT, Week 4, n=281, 277 Number Analyzed 281 participants 277 participants
25.1  (64.74) 17.9  (11.10)
ALT, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
20.8  (17.43) 18.4  (11.34)
ALT, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
21.4  (16.94) 19.2  (11.29)
ALT, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
21.6  (17.61) 20.3  (13.34)
ALT, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
25.8  (72.51) 19.6  (15.78)
ALT, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
23.9  (31.14) 19.1  (11.91)
ALT, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
22.5  (19.78) 19.6  (10.73)
ALT, Week 32, n=256, 268 Number Analyzed 256 participants 268 participants
38.5  (293.55) 19.0  (11.56)
ALT, Week 36, n=255, 261 Number Analyzed 255 participants 261 participants
20.3  (13.92) 21.2  (31.68)
ALT, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
20.9  (17.32) 19.5  (12.35)
ALT, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
22.2  (27.14) 19.8  (17.43)
ALT, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
20.1  (21.78) 19.7  (16.58)
ALP, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
66.5  (22.06) 67.1  (22.98)
ALP, Week 4, n=281, 277 Number Analyzed 281 participants 277 participants
66.2  (19.56) 65.5  (17.07)
ALP, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
66.8  (18.82) 66.3  (17.49)
ALP, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
66.8  (19.80) 66.1  (17.23)
ALP, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
66.7  (19.96) 66.1  (17.89)
ALP, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
67.6  (19.11) 65.6  (16.71)
ALP, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
67.1  (19.68) 66.1  (17.96)
ALP, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
67.4  (20.05) 67.5  (18.07)
ALP, Week 32, n=256, 268 Number Analyzed 256 participants 268 participants
68.0  (22.17) 66.6  (17.65)
ALP, Week 36, n=255, 261 Number Analyzed 255 participants 261 participants
69.5  (26.86) 68.3  (20.19)
ALP, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
67.4  (18.94) 67.7  (18.30)
ALP, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
67.7  (18.59) 68.2  (18.62)
ALP, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
66.4  (17.95) 67.7  (18.15)
AST, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
28.8  (90.66) 22.5  (14.80)
AST, Week 4, n=281, 277 Number Analyzed 281 participants 277 participants
25.1  (32.67) 20.9  (8.47)
AST, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
23.6  (20.85) 20.5  (6.26)
AST, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
22.8  (10.38) 21.0  (8.14)
AST, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
23.0  (10.71) 22.8  (14.03)
AST, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
25.3  (32.64) 22.7  (23.48)
AST, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
25.9  (25.16) 21.2  (9.73)
AST, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
24.8  (16.50) 21.7  (10.61)
AST, Week 32, n=256, 268 Number Analyzed 256 participants 268 participants
37.1  (233.23) 20.7  (6.42)
AST, Week 36, n=255, 261 Number Analyzed 255 participants 261 participants
23.0  (12.44) 22.4  (17.37)
AST, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
23.1  (12.22) 21.0  (6.51)
AST, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
24.4  (15.66) 21.9  (13.25)
AST Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
22.3  (10.98) 23.5  (42.49)
CK, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
197.8  (291.21) 199.8  (482.84)
CK, Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
230.2  (447.94) 173.0  (220.54)
CK, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
258.0  (928.82) 152.9  (146.05)
CK, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
201.8  (348.13) 182.6  (387.61)
CK, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
179.7  (248.71) 234.0  (576.62)
CK, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
215.7  (539.34) 258.9  (1109.04)
CK, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
248.6  (628.44) 183.1  (368.02)
CK, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
252.7  (673.98) 194.5  (506.24)
CK, Week 32, n=256, 268 Number Analyzed 256 participants 268 participants
175.8  (223.16) 160.0  (176.09)
CK, Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
219.0  (507.30) 215.2  (460.38)
CK, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
220.5  (507.68) 149.5  (115.14)
CK, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
254.0  (477.19) 181.9  (428.28)
CK, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
185.5  (227.54) 323.6  (2637.27)
18.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 timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
43.8  (3.04) 44.1  (2.80)
Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
43.7  (3.03) 43.8  (2.70)
Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
43.5  (2.85) 43.9  (2.76)
Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
43.7  (3.06) 44.1  (2.87)
Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
44.1  (2.99) 44.0  (2.78)
Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
44.1  (3.11) 43.9  (2.72)
Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
44.3  (3.08) 44.2  (2.60)
Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
44.4  (3.09) 44.5  (2.66)
Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
44.6  (3.17) 44.4  (2.76)
Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
44.1  (3.05) 44.3  (2.63)
Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
44.8  (3.02) 44.5  (2.76)
Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
44.7  (2.98) 44.4  (2.71)
Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
44.6  (2.98) 44.6  (2.86)
19.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 timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
9.3  (5.12) 9.4  (4.68)
Bilirubin, Week 4, n=281, 277 Number Analyzed 281 participants 277 participants
10.7  (6.37) 8.9  (4.40)
Bilirubin, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
10.1  (4.62) 8.8  (3.85)
Bilirubin, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
10.5  (5.45) 8.6  (3.53)
Bilirubin, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
10.6  (5.49) 8.7  (3.74)
Bilirubin, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
10.3  (5.29) 8.5  (3.40)
Bilirubin, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
10.0  (5.09) 8.9  (3.86)
Bilirubin, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
10.4  (5.67) 8.6  (3.90)
Bilirubin, Week 32, n=256, 268 Number Analyzed 256 participants 268 participants
10.5  (7.86) 8.7  (3.95)
Bilirubin, Week 36, n=255, 260 Number Analyzed 255 participants 260 participants
9.9  (6.35) 8.5  (3.42)
Bilirubin, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
10.2  (5.26) 8.5  (3.52)
Bilirubin, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
10.3  (5.15) 8.8  (3.78)
Bilirubin, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
10.3  (5.23) 8.9  (3.71)
Direct bilirubin, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
2.3  (1.32) 2.2  (1.09)
Direct bilirubin, Week 4, n=277, 277 Number Analyzed 277 participants 277 participants
2.4  (1.47) 2.1  (1.08)
Direct bilirubin, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
2.4  (1.17) 2.1  (0.93)
Direct bilirubin, Week 12, n=269, 273 Number Analyzed 269 participants 273 participants
2.5  (1.26) 2.1  (0.91)
Direct bilirubin, Week 16, n=254, 268 Number Analyzed 254 participants 268 participants
2.4  (1.46) 2.1  (0.95)
Direct bilirubin, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
2.4  (1.54) 2.1  (0.90)
Direct bilirubin, Week 24, n=260, 266 Number Analyzed 260 participants 266 participants
2.3  (1.20) 2.1  (0.96)
Direct bilirubin, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
2.5  (1.29) 2.1  (0.94)
Direct bilirubin, Week 32, n=256, 268 Number Analyzed 256 participants 268 participants
2.5  (3.48) 2.1  (0.94)
Direct bilirubin, Week 36, n=255, 260 Number Analyzed 255 participants 260 participants
2.4  (2.24) 2.0  (0.89)
Direct bilirubin, Week 40, n=249, 266 Number Analyzed 249 participants 266 participants
2.3  (1.29) 2.1  (0.98)
Direct bilirubin, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
2.4  (1.34) 2.1  (0.95)
Direct bilirubin, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
2.3  (1.26) 2.2  (1.00)
Creatinine, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
89.00  (16.061) 85.80  (15.660)
Creatinine, Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
82.99  (15.599) 86.43  (14.655)
Creatinine, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
79.50  (14.103) 85.50  (15.925)
Creatinine, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
79.25  (14.433) 84.63  (15.155)
Creatinine, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
79.58  (14.509) 85.18  (14.997)
Creatinine, Week 20, n=261, 272 Number Analyzed 261 participants 272 participants
78.50  (13.966) 85.02  (15.488)
Creatinine, Week 24, n=262, 268 Number Analyzed 262 participants 268 participants
79.10  (15.340) 85.05  (14.690)
Creatinine, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
78.79  (14.741) 84.38  (15.023)
Creatinine, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
78.89  (14.558) 84.50  (15.047)
Creatinine, Week 36, n=254, 262 Number Analyzed 254 participants 262 participants
79.58  (14.973) 84.75  (14.352)
Creatinine, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
79.50  (15.615) 84.70  (14.808)
Creatinine, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
80.04  (15.401) 83.90  (14.604)
Creatinine, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
79.95  (15.613) 90.88  (87.655)
20.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 timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
CO2, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
22.4  (2.24) 22.4  (2.10)
CO2, Week 4, n=280, 276 Number Analyzed 280 participants 276 participants
23.0  (2.29) 22.6  (2.28)
CO2, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
22.8  (2.07) 22.3  (2.27)
CO2, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
22.6  (2.50) 22.2  (2.34)
CO2, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
22.9  (2.40) 22.3  (2.50)
CO2, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
22.8  (2.30) 22.4  (2.32)
CO2, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
23.0  (2.71) 22.8  (2.19)
CO2, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
23.0  (2.31) 22.8  (2.47)
CO2, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
23.0  (2.31) 22.7  (2.35)
CO2, Week 36, n=253, 261 Number Analyzed 253 participants 261 participants
23.1  (2.37) 22.5  (2.26)
CO2, Week 40, n=249, 265 Number Analyzed 249 participants 265 participants
22.8  (2.34) 22.6  (2.39)
CO2, Week 44, n=257, 263 Number Analyzed 257 participants 263 participants
22.9  (2.34) 22.4  (2.12)
CO2, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
22.5  (2.18) 22.3  (2.04)
Chloride, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
104.6  (2.32) 104.3  (2.32)
Chloride, Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
104.6  (2.22) 104.7  (2.13)
Chloride, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
104.7  (1.96) 104.6  (2.32)
Chloride, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
104.6  (2.16) 104.7  (2.35)
Chloride, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
104.4  (2.31) 104.7  (2.24)
Chloride, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
104.3  (2.28) 104.7  (2.06)
Chloride, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
104.4  (2.33) 104.5  (2.42)
Chloride, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
104.5  (2.20) 104.5  (2.28)
Chloride, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
104.4  (2.46) 104.5  (2.33)
Chloride, Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
104.4  (2.42) 104.7  (2.20)
Chloride, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
104.8  (2.55) 104.7  (2.25)
Chloride, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
104.7  (2.19) 105.0  (2.22)
Chloride, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
104.7  (2.21) 104.7  (2.28)
Glucose, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
5.21  (1.632) 5.17  (0.932)
Glucose, Week 4, n=236, 230 Number Analyzed 236 participants 230 participants
5.27  (1.322) 5.23  (0.734)
Glucose, Week 8, n=172, 227 Number Analyzed 172 participants 227 participants
5.31  (1.347) 5.19  (0.644)
Glucose, Week 12, n=229, 216 Number Analyzed 229 participants 216 participants
5.26  (0.911) 5.27  (0.616)
Glucose, Week 16, n=204, 213 Number Analyzed 204 participants 213 participants
5.36  (1.804) 5.28  (0.801)
Glucose, Week 20, n=209, 218 Number Analyzed 209 participants 218 participants
5.32  (0.735) 5.26  (0.634)
Glucose, Week 24, n=221, 214 Number Analyzed 221 participants 214 participants
5.35  (1.219) 5.21  (0.634)
Glucose, Week 28, n=207, 211 Number Analyzed 207 participants 211 participants
5.35  (1.633) 5.23  (0.614)
Glucose, Week 32, n=201, 213 Number Analyzed 201 participants 213 participants
5.44  (1.355) 5.27  (0.600)
Glucose, Week 36, n=199, 204 Number Analyzed 199 participants 204 participants
5.35  (0.797) 5.31  (0.960)
Glucose, Week 40, n=203, 202 Number Analyzed 203 participants 202 participants
5.44  (1.319) 5.35  (0.753)
Glucose, Week 44, n=208, 202 Number Analyzed 208 participants 202 participants
5.34  (0.991) 5.35  (0.709)
Glucose, Week 48, n=248, 251 Number Analyzed 248 participants 251 participants
5.22  (0.895) 5.22  (0.690)
Phosphate, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
1.103  (0.1747) 1.097  (0.1765)
Phosphate, Week 4, n=279, 277 Number Analyzed 279 participants 277 participants
1.137  (0.1774) 1.112  (0.1850)
Phosphate, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
1.096  (0.1742) 1.114  (0.1858)
Phosphate, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
1.097  (0.1802) 1.106  (0.1876)
Phosphate, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
1.104  (0.1806) 1.119  (0.1823)
Phosphate, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
1.078  (0.1843) 1.114  (0.1812)
Phosphate, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
1.106  (0.1797) 1.109  (0.1791)
Phosphate, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
1.094  (0.1814) 1.119  (0.1893)
Phosphate, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
1.105  (0.1769) 1.104  (0.1945)
Phosphate, Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
1.102  (0.1862) 1.122  (0.1872)
Phosphate, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
1.093  (0.1699) 1.114  (0.1837)
Phosphate, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
1.096  (0.1851) 1.120  (0.1903)
Phosphate, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
1.096  (0.1888) 1.120  (0.2341)
Potassium, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
4.12  (0.301) 4.14  (0.288)
Potassium, Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
4.27  (0.308) 4.20  (0.327)
Potassium, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
4.22  (0.302) 4.22  (0.343)
Potassium, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
4.21  (0.305) 4.19  (0.282)
Potassium, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
4.21  (0.283) 4.18  (0.303)
Potassium, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
4.21  (0.320) 4.19  (0.313)
Potassium, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
4.24  (0.322) 4.21  (0.312)
Potassium, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
4.20  (0.298) 4.23  (0.294)
Potassium, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
4.21  (0.295) 4.21  (0.315)
Potassium, Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
4.21  (0.314) 4.22  (0.314)
Potassium, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
4.19  (0.301) 4.20  (0.305)
Potassium, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
4.21  (0.302) 4.21  (0.324)
Potassium, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
4.13  (0.288) 4.17  (0.449)
Sodium, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
139.2  (1.89) 139.2  (1.76)
Sodium, Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
139.5  (1.98) 139.4  (1.83)
Sodium, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
139.4  (1.78) 139.3  (1.86)
Sodium, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
139.5  (1.80) 139.3  (1.84)
Sodium, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
139.4  (1.76) 139.4  (1.94)
Sodium, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
139.4  (1.75) 139.5  (1.77)
Sodium, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
139.3  (1.82) 139.4  (1.95)
Sodium, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
139.4  (1.80) 139.5  (1.83)
Sodium, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
139.4  (1.83) 139.4  (1.72)
Sodium, Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
139.3  (1.87) 139.5  (1.70)
Sodium, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
139.3  (2.04) 139.5  (1.84)
Sodium, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
139.5  (1.95) 139.6  (1.79)
Sodium, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
139.4  (1.68) 139.5  (1.75)
Urea, Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
5.30  (1.468) 5.17  (1.458)
Urea, Week 4, n=280, 277 Number Analyzed 280 participants 277 participants
5.33  (1.424) 5.14  (1.508)
Urea, Week 8, n=212, 278 Number Analyzed 212 participants 278 participants
5.32  (1.485) 5.12  (1.480)
Urea, Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
5.28  (1.424) 5.20  (1.574)
Urea, Week 16, n=255, 269 Number Analyzed 255 participants 269 participants
5.26  (1.385) 5.20  (1.561)
Urea, Week 20, n=260, 272 Number Analyzed 260 participants 272 participants
5.18  (1.349) 5.22  (1.483)
Urea, Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
5.38  (1.489) 5.11  (1.449)
Urea, Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
5.32  (1.422) 5.21  (1.406)
Urea, Week 32, n=255, 268 Number Analyzed 255 participants 268 participants
5.43  (1.440) 5.17  (1.491)
Urea, Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
5.31  (1.396) 5.23  (1.556)
Urea, Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
5.40  (1.523) 5.26  (1.566)
Urea, Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
5.38  (1.543) 5.24  (1.512)
Urea, Week 48, n=247, 262 Number Analyzed 247 participants 262 participants
5.37  (1.402) 5.27  (2.305)
21.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 timepoints.
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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Units per liter
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
31.0  (21.04) 30.9  (28.89)
Week 4, n=278, 276 Number Analyzed 278 participants 276 participants
31.7  (27.17) 32.6  (24.73)
Week 8, n=211, 278 Number Analyzed 211 participants 278 participants
31.5  (21.15) 31.3  (19.96)
Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
31.4  (23.94) 33.6  (23.37)
Week 16, n=254, 269 Number Analyzed 254 participants 269 participants
30.8  (22.39) 32.1  (18.99)
Week 20, n=260, 270 Number Analyzed 260 participants 270 participants
31.3  (23.46) 31.9  (19.13)
Week 24, n=260, 268 Number Analyzed 260 participants 268 participants
31.3  (22.60) 32.2  (21.08)
Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
30.3  (18.71) 33.0  (22.56)
Week 32, n=254, 268 Number Analyzed 254 participants 268 participants
33.5  (35.38) 33.2  (32.95)
Week 36, n=254, 261 Number Analyzed 254 participants 261 participants
31.5  (20.49) 31.2  (20.03)
Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
32.6  (27.07) 32.1  (22.19)
Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
36.3  (45.04) 33.0  (24.09)
Week 48, n=247, 261 Number Analyzed 247 participants 261 participants
30.1  (20.31) 32.6  (28.96)
22.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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73/m^2
Baseline (Day 1), n=283, 283 Number Analyzed 283 participants 283 participants
94.3  (17.61) 97.9  (17.70)
Week 4, n=278, 277 Number Analyzed 278 participants 277 participants
101.2  (16.56) 96.5  (17.14)
Week 8, n=211, 278 Number Analyzed 211 participants 278 participants
104.9  (15.64) 98.1  (17.46)
Week 12, n=270, 276 Number Analyzed 270 participants 276 participants
104.8  (16.08) 98.6  (17.77)
Week 16, n=254, 269 Number Analyzed 254 participants 269 participants
104.2  (15.03) 97.6  (16.84)
Week 20, n=261, 271 Number Analyzed 261 participants 271 participants
105.5  (15.19) 98.0  (17.67)
Week 24, n=261, 268 Number Analyzed 261 participants 268 participants
105.1  (16.05) 97.9  (17.33)
Week 28, n=253, 268 Number Analyzed 253 participants 268 participants
105.3  (16.18) 98.8  (17.40)
Week 32, n=254, 268 Number Analyzed 254 participants 268 participants
105.1  (16.10) 98.8  (17.39)
Week 36, n=254, 262 Number Analyzed 254 participants 262 participants
104.7  (15.88) 98.0  (16.60)
Week 40, n=250, 266 Number Analyzed 250 participants 266 participants
104.3  (16.47) 98.3  (17.25)
Week 44, n=258, 263 Number Analyzed 258 participants 263 participants
104.4  (16.73) 98.9  (16.67)
Week 48, n=247, 261 Number Analyzed 247 participants 261 participants
103.6  (16.34) 96.9  (18.21)
23.Secondary Outcome
Title Absolute Values for Fasting Lipid Panel Overtime Including Week 48
Hide Description Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.
Time Frame Baseline (Day 1) and at Week 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Total Cholesterol, Baseline (Day 1), n=268, 275 Number Analyzed 268 participants 275 participants
4.44  (0.928) 4.42  (0.986)
Total Cholesterol, Week 48, n=240, 239 Number Analyzed 240 participants 239 participants
4.65  (1.021) 4.46  (0.944)
HDL cholesterol, Baseline (Day 1), n=268, 275 Number Analyzed 268 participants 275 participants
1.249  (0.3761) 1.302  (0.3851)
HDL cholesterol, Week 48, n=240, 239 Number Analyzed 240 participants 239 participants
1.359  (0.4096) 1.376  (0.4335)
LDL cholesterol, Baseline (Day 1), n=267, 275 Number Analyzed 267 participants 275 participants
2.557  (0.7991) 2.529  (0.7870)
LDL cholesterol, Week 48, n=238, 237 Number Analyzed 238 participants 237 participants
2.697  (0.9158) 2.472  (0.7693)
Triglycerides, Baseline (Day 1), n=268, 275 Number Analyzed 268 participants 275 participants
1.387  (0.9142) 1.294  (0.7392)
Triglycerides, Week 48, n=240, 239 Number Analyzed 240 participants 239 participants
1.323  (0.9333) 1.341  (0.9059)
24.Secondary Outcome
Title Number of Participants With Abnormal Urinalysis Parameter 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 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
Urine bilirubin,Baseline (Day 1),Trace, n=276, 276 Number Analyzed 276 participants 276 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Baseline (Day 1), 1+, n=276, 276 Number Analyzed 276 participants 276 participants
15
   5.4%
22
   8.0%
Urine bilirubin, Baseline (Day 1), 2+, n=276, 276 Number Analyzed 276 participants 276 participants
0
   0.0%
1
   0.4%
Urine bilirubin, Baseline (Day 1), 3+, n=276, 276 Number Analyzed 276 participants 276 participants
0
   0.0%
0
   0.0%
Urine glucose, Baseline (Day 1), Trace, n=282, 282 Number Analyzed 282 participants 282 participants
0
   0.0%
1
   0.4%
Urine glucose, Baseline (Day 1), 1+, n=282, 282 Number Analyzed 282 participants 282 participants
2
   0.7%
0
   0.0%
Urine glucose, Baseline (Day 1), 2+, n=282, 282 Number Analyzed 282 participants 282 participants
0
   0.0%
0
   0.0%
Urine glucose, Baseline (Day 1), 3+, n=282, 282 Number Analyzed 282 participants 282 participants
1
   0.4%
1
   0.4%
Urine ketones, Baseline (Day 1), Trace, n=276, 276 Number Analyzed 276 participants 276 participants
30
  10.9%
29
  10.5%
Urine ketones, Baseline (Day 1), 1+, n=276, 276 Number Analyzed 276 participants 276 participants
4
   1.4%
2
   0.7%
Urine ketones, Baseline (Day 1), 2+, n=276, 276 Number Analyzed 276 participants 276 participants
0
   0.0%
1
   0.4%
Urine ketones, Baseline (Day 1), 3+, n=276, 276 Number Analyzed 276 participants 276 participants
0
   0.0%
0
   0.0%
Urine leukocyte esterase,Baseline,Trace,n=276, 276 Number Analyzed 276 participants 276 participants
22
   8.0%
21
   7.6%
Urine leukocyte esterase, Baseline, 1+, n=276, 276 Number Analyzed 276 participants 276 participants
12
   4.3%
14
   5.1%
Urine leukocyte esterase, Baseline, 2+, n=276, 276 Number Analyzed 276 participants 276 participants
9
   3.3%
9
   3.3%
Urine leukocyte esterase, Baseline, 3+, n=276, 276 Number Analyzed 276 participants 276 participants
3
   1.1%
3
   1.1%
Urine nitrite, Baseline, positive, n=276, 276 Number Analyzed 276 participants 276 participants
6
   2.2%
9
   3.3%
Urine occult blood, Baseline, Trace, n=276, 276 Number Analyzed 276 participants 276 participants
13
   4.7%
9
   3.3%
Urine occult blood, Baseline, 1+, n=276, 276 Number Analyzed 276 participants 276 participants
5
   1.8%
6
   2.2%
Urine occult blood, Baseline, 2+, n=276, 276 Number Analyzed 276 participants 276 participants
6
   2.2%
3
   1.1%
Urine occult blood, Baseline, 3+, n=276, 276 Number Analyzed 276 participants 276 participants
3
   1.1%
2
   0.7%
Urine protein, Baseline, Trace, n=276, 276 Number Analyzed 276 participants 276 participants
25
   9.1%
20
   7.2%
Urine protein, Baseline, 1+, n=276, 276 Number Analyzed 276 participants 276 participants
4
   1.4%
10
   3.6%
Urine protein, Baseline, 2+, n=276, 276 Number Analyzed 276 participants 276 participants
3
   1.1%
7
   2.5%
Urine protein, Baseline, 3+, n=276, 276 Number Analyzed 276 participants 276 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 4, Trace, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 4, 1+, n=278, 272 Number Analyzed 278 participants 272 participants
14
   5.0%
28
  10.3%
Urine bilirubin, Week 4, 2+, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 4, 3+, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 4, Trace, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 4, 1+, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
2
   0.7%
Urine glucose, Week 4, 2+, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 4, 3+, n=278, 272 Number Analyzed 278 participants 272 participants
1
   0.4%
0
   0.0%
Urine ketones, Week 4, Trace, n=278, 272 Number Analyzed 278 participants 272 participants
20
   7.2%
21
   7.7%
Urine ketones, Week 4, 1+, n=278, 272 Number Analyzed 278 participants 272 participants
1
   0.4%
5
   1.8%
Urine ketones, Week 4, 2+, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
0
   0.0%
Urine ketones, Week 4, 3+, n=278, 272 Number Analyzed 278 participants 272 participants
1
   0.4%
0
   0.0%
Urine leukocyte esterase, Week 4, Trace,n=278, 272 Number Analyzed 278 participants 272 participants
19
   6.8%
23
   8.5%
Urine leukocyte esterase, Week 4, 1+, n=278, 272 Number Analyzed 278 participants 272 participants
9
   3.2%
17
   6.3%
Urine leukocyte esterase, Week 4, 2+, n=278, 272 Number Analyzed 278 participants 272 participants
6
   2.2%
6
   2.2%
Urine leukocyte esterase, Week 4, 3+, n=278, 272 Number Analyzed 278 participants 272 participants
2
   0.7%
4
   1.5%
Urine nitrite, Week 4, positive, n=278, 272 Number Analyzed 278 participants 272 participants
2
   0.7%
10
   3.7%
Urine occult blood, Week 4, Trace, n=278, 272 Number Analyzed 278 participants 272 participants
11
   4.0%
13
   4.8%
Urine occult blood, Week 4, 1+, n=278, 272 Number Analyzed 278 participants 272 participants
8
   2.9%
3
   1.1%
Urine occult blood, Week 4, 2+, n=278, 272 Number Analyzed 278 participants 272 participants
5
   1.8%
1
   0.4%
Urine occult blood, Week 4, 3+, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
6
   2.2%
Urine protein, Week 4, Trace, n=278, 272 Number Analyzed 278 participants 272 participants
12
   4.3%
24
   8.8%
Urine protein, Week 4, 1+, n=278, 272 Number Analyzed 278 participants 272 participants
4
   1.4%
11
   4.0%
Urine protein, Week 4, 2+, n=278, 272 Number Analyzed 278 participants 272 participants
1
   0.4%
3
   1.1%
Urine protein, Week 4, 3+, n=278, 272 Number Analyzed 278 participants 272 participants
1
   0.4%
1
   0.4%
Urine bilirubin, Week 24, Trace, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 24, 1+, n=195, 258 Number Analyzed 195 participants 258 participants
7
   3.6%
14
   5.4%
, Urine bilirubin, Week 24, 2+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 24, 3+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 24, Trace, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 24, 1+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 24, 2+, n=195, 258 Number Analyzed 195 participants 258 participants
1
   0.5%
0
   0.0%
Urine glucose, Week 24, 3+, n=195, 258 Number Analyzed 195 participants 258 participants
1
   0.5%
1
   0.4%
Urine ketones, Week 24, Trace, n=195, 258 Number Analyzed 195 participants 258 participants
13
   6.7%
9
   3.5%
Urine ketones, Week 24, 1+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
2
   0.8%
Urine ketones, Week 24, 2+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine ketones, Week 24, 3+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
0
   0.0%
Urine leukocyte esterase,Week 24, Trace,n=195, 258 Number Analyzed 195 participants 258 participants
15
   7.7%
28
  10.9%
Urine leukocyte esterase, Week 24, 1+, n=195, 258 Number Analyzed 195 participants 258 participants
8
   4.1%
12
   4.7%
Urine leukocyte esterase, Week 24, 2+, n=195, 258 Number Analyzed 195 participants 258 participants
3
   1.5%
10
   3.9%
Urine leukocyte esterase, Week 24, 3+, n=195, 258 Number Analyzed 195 participants 258 participants
1
   0.5%
3
   1.2%
Urine nitrite, Week 24, positive, n=195, 258 Number Analyzed 195 participants 258 participants
4
   2.1%
5
   1.9%
Urine occult blood, Week 24, Trace, n=195, 258 Number Analyzed 195 participants 258 participants
9
   4.6%
9
   3.5%
Urine occult blood, Week 24, 1+, n=195, 258 Number Analyzed 195 participants 258 participants
3
   1.5%
8
   3.1%
Urine occult blood, Week 24, 2+, n=195, 258 Number Analyzed 195 participants 258 participants
3
   1.5%
2
   0.8%
Urine occult blood, Week 24, 3+, n=195, 258 Number Analyzed 195 participants 258 participants
1
   0.5%
3
   1.2%
Urine protein, Week 24, Trace, n=195, 258 Number Analyzed 195 participants 258 participants
11
   5.6%
21
   8.1%
Urine protein, Week 24, 1+, n=195, 258 Number Analyzed 195 participants 258 participants
4
   2.1%
7
   2.7%
Urine protein, Week 24, 2+, n=195, 258 Number Analyzed 195 participants 258 participants
2
   1.0%
4
   1.6%
Urine protein, Week 24, 3+, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
1
   0.4%
Urine bilirubin, Week 48, Trace, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 48, 1+, n=261, 259 Number Analyzed 261 participants 259 participants
9
   3.4%
12
   4.6%
Urine bilirubin, Week 48, 2+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
Urine bilirubin, Week 48, 3+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
1
   0.4%
Urine glucose, Week 48, Trace, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 48, 1+, n=261, 259 Number Analyzed 261 participants 259 participants
1
   0.4%
0
   0.0%
Urine glucose, Week 48, 2+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
Urine glucose, Week 48, 3+, n=261, 259 Number Analyzed 261 participants 259 participants
2
   0.8%
0
   0.0%
Urine ketones, Week 48, Trace, n=261, 259 Number Analyzed 261 participants 259 participants
12
   4.6%
13
   5.0%
Urine ketones, Week 48, 1+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
4
   1.5%
Urine ketones, Week 48, 2+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
Urine ketones, Week 48, 3+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
Urine leukocyte esterase, Week 48,Trace,n=261, 259 Number Analyzed 261 participants 259 participants
12
   4.6%
15
   5.8%
Urine leukocyte esterase, Week 48, 1+, n=261, 259 Number Analyzed 261 participants 259 participants
5
   1.9%
10
   3.9%
Urine leukocyte esterase, Week 48, 2+, n=261, 259 Number Analyzed 261 participants 259 participants
4
   1.5%
7
   2.7%
Urine leukocyte esterase, Week 48, 3+, n=261, 259 Number Analyzed 261 participants 259 participants
2
   0.8%
2
   0.8%
Urine nitrite, Week 48, positive, n=261, 259 Number Analyzed 261 participants 259 participants
2
   0.8%
6
   2.3%
Urine occult blood, Week 48, Trace, n=261, 259 Number Analyzed 261 participants 259 participants
9
   3.4%
8
   3.1%
Urine occult blood, Week 48, 1+, n=261, 259 Number Analyzed 261 participants 259 participants
4
   1.5%
6
   2.3%
Urine occult blood, Week 48, 2+, n=261, 259 Number Analyzed 261 participants 259 participants
8
   3.1%
3
   1.2%
Urine occult blood, Week 48, 3+, n=261, 259 Number Analyzed 261 participants 259 participants
1
   0.4%
0
   0.0%
Urine protein, Week 48, Trace, n=261, 259 Number Analyzed 261 participants 259 participants
14
   5.4%
23
   8.9%
Urine protein, Week 48, 1+, n=261, 259 Number Analyzed 261 participants 259 participants
5
   1.9%
8
   3.1%
Urine protein, Week 48, 2+, n=261, 259 Number Analyzed 261 participants 259 participants
6
   2.3%
6
   2.3%
Urine protein, Week 48, 3+, n=261, 259 Number Analyzed 261 participants 259 participants
0
   0.0%
0
   0.0%
25.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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (Day 1), pH=5, n=276, 276 Number Analyzed 276 participants 276 participants
36
  13.0%
32
  11.6%
Baseline (Day 1), pH=5.5, n=276, 276 Number Analyzed 276 participants 276 participants
104
  37.7%
101
  36.6%
Baseline (Day 1), pH=6, n=276, 276 Number Analyzed 276 participants 276 participants
66
  23.9%
62
  22.5%
Baseline (Day 1), pH=6.5, n=276, 276 Number Analyzed 276 participants 276 participants
29
  10.5%
35
  12.7%
Baseline (Day 1), pH=7, n=276, 276 Number Analyzed 276 participants 276 participants
27
   9.8%
27
   9.8%
Baseline (Day 1), pH=7.5, n=276, 276 Number Analyzed 276 participants 276 participants
7
   2.5%
12
   4.3%
Baseline (Day 1), pH=8, n=276, 276 Number Analyzed 276 participants 276 participants
4
   1.4%
4
   1.4%
Baseline (Day 1), pH=8.5, n=276, 276 Number Analyzed 276 participants 276 participants
2
   0.7%
1
   0.4%
Baseline (Day 1), pH>9.0, n=276, 276 Number Analyzed 276 participants 276 participants
1
   0.4%
2
   0.7%
Week 4, pH=5, n=278, 272 Number Analyzed 278 participants 272 participants
33
  11.9%
41
  15.1%
Week 4, pH=5.5, n=278, 272 Number Analyzed 278 participants 272 participants
83
  29.9%
81
  29.8%
Week 4, pH=6, n=278, 272 Number Analyzed 278 participants 272 participants
68
  24.5%
71
  26.1%
Week 4, pH=6.5, n=278, 272 Number Analyzed 278 participants 272 participants
48
  17.3%
36
  13.2%
Week 4, pH=7, n=278, 272 Number Analyzed 278 participants 272 participants
25
   9.0%
22
   8.1%
Week 4, pH=7.5, n=278, 272 Number Analyzed 278 participants 272 participants
10
   3.6%
12
   4.4%
Week 4, pH=8, n=278, 272 Number Analyzed 278 participants 272 participants
5
   1.8%
5
   1.8%
Week 4, pH=8.5, n=278, 272 Number Analyzed 278 participants 272 participants
6
   2.2%
1
   0.4%
Week 4, pH>9.0, n=278, 272 Number Analyzed 278 participants 272 participants
0
   0.0%
3
   1.1%
Week 24, pH=5, n=195, 258 Number Analyzed 195 participants 258 participants
42
  21.5%
50
  19.4%
Week 24, pH=5.5, n=195, 258 Number Analyzed 195 participants 258 participants
55
  28.2%
78
  30.2%
Week 24, pH=6, n=195, 258 Number Analyzed 195 participants 258 participants
47
  24.1%
51
  19.8%
Week 24, pH=6.5, n=195, 258 Number Analyzed 195 participants 258 participants
19
   9.7%
46
  17.8%
Week 24, pH=7, n=195, 258 Number Analyzed 195 participants 258 participants
22
  11.3%
16
   6.2%
Week 24, pH=7.5, n=195, 258 Number Analyzed 195 participants 258 participants
4
   2.1%
13
   5.0%
Week 24, pH=8, n=195, 258 Number Analyzed 195 participants 258 participants
3
   1.5%
2
   0.8%
Week 24, pH=8.5, n=195, 258 Number Analyzed 195 participants 258 participants
3
   1.5%
1
   0.4%
Week 24, pH>9.0, n=195, 258 Number Analyzed 195 participants 258 participants
0
   0.0%
1
   0.4%
Week 48, pH=5, n=261, 259 Number Analyzed 261 participants 259 participants
54
  20.7%
57
  22.0%
Week 48, pH=5.5, n=261, 259 Number Analyzed 261 participants 259 participants
81
  31.0%
77
  29.7%
Week 48, pH=6, n=261, 259 Number Analyzed 261 participants 259 participants
50
  19.2%
61
  23.6%
Week 48, pH=6.5, n=261, 259 Number Analyzed 261 participants 259 participants
30
  11.5%
27
  10.4%
Week 48, pH=7, n=261, 259 Number Analyzed 261 participants 259 participants
24
   9.2%
18
   6.9%
Week 48, pH=7.5, n=261, 259 Number Analyzed 261 participants 259 participants
14
   5.4%
10
   3.9%
Week 48, pH=8, n=261, 259 Number Analyzed 261 participants 259 participants
5
   1.9%
4
   1.5%
Week 48, pH=8.5, n=261, 259 Number Analyzed 261 participants 259 participants
2
   0.8%
3
   1.2%
Week 48, pH>9.0, n=261, 259 Number Analyzed 261 participants 259 participants
1
   0.4%
2
   0.8%
26.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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per Liter
Basophils, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.002  (0.0155) 0.002  (0.0155)
Basophils, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.002  (0.0161) 0.001  (0.0153)
Basophils, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.003  (0.0181) 0.001  (0.0157)
Basophils, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.008  (0.0215) 0.006  (0.0227)
Basophils, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.013  (0.0250) 0.010  (0.0271)
Basophils, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.015  (0.0247) 0.014  (0.0269)
Basophils, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.017  (0.0265) 0.016  (0.0251)
Basophils, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.022  (0.0266) 0.017  (0.0227)
Basophils, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.021  (0.0235) 0.018  (0.0249)
Basophils, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.020  (0.0252) 0.019  (0.0243)
Basophils, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.018  (0.0246) 0.018  (0.0265)
Basophils, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.016  (0.0218) 0.016  (0.0243)
Eosinophils, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.024  (0.1099) 0.013  (0.1220)
Eosinophils, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.023  (0.1101) 0.009  (0.1075)
Eosinophils, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.023  (0.1305) 0.018  (0.1082)
Eosinophils, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.037  (0.1425) 0.022  (0.1262)
Eosinophils, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.044  (0.1478) 0.027  (0.1288)
Eosinophils, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.051  (0.1307) 0.030  (0.1124)
Eosinophils, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.061  (0.1367) 0.037  (0.1393)
Eosinophils, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.061  (0.1556) 0.029  (0.1158)
Eosinophils, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.070  (0.1797) 0.030  (0.1303)
Eosinophils, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.062  (0.1623) 0.035  (0.1155)
Eosinophils, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.057  (0.1598) 0.038  (0.1410)
Eosinophils, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.039  (0.1416) 0.030  (0.1183)
Leukocytes, Week 4, n=279, 272 Number Analyzed 279 participants 272 participants
0.57  (1.404) 0.42  (1.383)
Leukocytes, Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
0.18  (1.278) 0.32  (1.374)
Leukocytes, Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
0.07  (1.402) 0.40  (1.465)
Leukocytes, Week 16, n=252, 265 Number Analyzed 252 participants 265 participants
0.32  (1.641) 0.41  (1.621)
Leukocytes, Week 20, n=254, 265 Number Analyzed 254 participants 265 participants
0.27  (1.505) 0.44  (1.480)
Leukocytes, Week 24, n=258, 264 Number Analyzed 258 participants 264 participants
0.34  (1.581) 0.45  (1.725)
Leukocytes, Week 28, n=244, 263 Number Analyzed 244 participants 263 participants
0.34  (1.713) 0.48  (1.551)
Leukocytes, Week 32, n=253, 266 Number Analyzed 253 participants 266 participants
0.28  (1.726) 0.42  (1.748)
Leukocytes, Week 36, n=252, 259 Number Analyzed 252 participants 259 participants
0.34  (1.549) 0.52  (1.789)
Leukocytes, Week 40, n=246, 253 Number Analyzed 246 participants 253 participants
0.16  (1.497) 0.42  (1.614)
Leukocytes, Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
0.22  (1.732) 0.49  (1.626)
Leukocytes, Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
0.09  (1.455) 0.29  (1.520)
Lymphocytes, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.198  (0.5156) 0.231  (0.5066)
Lymphocytes, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.054  (0.4812) 0.155  (0.5088)
Lymphocytes, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.012  (0.4632) 0.164  (0.5560)
Lymphocytes, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.020  (0.4971) 0.158  (0.5246)
Lymphocytes, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.030  (0.4889) 0.146  (0.5292)
Lymphocytes, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.014  (0.5195) 0.148  (0.5716)
Lymphocytes, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.021  (0.5389) 0.145  (0.5469)
Lymphocytes, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.021  (0.5195) 0.129  (0.5812)
Lymphocytes, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.028  (0.5261) 0.132  (0.5258)
Lymphocytes, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.006  (0.5303) 0.054  (0.5106)
Lymphocytes, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
-0.021  (0.6176) 0.098  (0.5139)
Lymphocytes, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
-0.074  (0.5191) 0.039  (0.5936)
Monocytes, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.038  (0.1269) 0.031  (0.1528)
Monocytes, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.022  (0.1464) 0.013  (0.1600)
Monocytes, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.016  (0.1234) 0.018  (0.1613)
Monocytes, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.059  (0.1548) 0.035  (0.1618)
Monocytes, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.070  (0.1583) 0.053  (0.1790)
Monocytes, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.059  (0.1442) 0.070  (0.1599)
Monocytes, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.086  (0.1584) 0.077  (0.1806)
Monocytes, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.081  (0.1530) 0.088  (0.1841)
Monocytes, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.084  (0.1685) 0.086  (0.1772)
Monocytes, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.056  (0.1378) 0.076  (0.1651)
Monocytes, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.062  (0.1522) 0.057  (0.1558)
Monocytes, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.024  (0.1395) 0.031  (0.1389)
Neutrophils, Week 4, n=277, 270 Number Analyzed 277 participants 270 participants
0.313  (1.3508) 0.130  (1.1869)
Neutrophils, Week 8, n=210, 272 Number Analyzed 210 participants 272 participants
0.084  (1.1310) 0.125  (1.2775)
Neutrophils, Week 12, n=267, 272 Number Analyzed 267 participants 272 participants
0.032  (1.3016) 0.185  (1.3016)
Neutrophils, Week 16, n=247, 259 Number Analyzed 247 participants 259 participants
0.215  (1.5752) 0.211  (1.4233)
Neutrophils, Week 20, n=247, 259 Number Analyzed 247 participants 259 participants
0.132  (1.4116) 0.217  (1.3130)
Neutrophils, Week 24, n=256, 260 Number Analyzed 256 participants 260 participants
0.218  (1.4890) 0.217  (1.4694)
Neutrophils, Week 28, n=239, 258 Number Analyzed 239 participants 258 participants
0.193  (1.5833) 0.221  (1.3274)
Neutrophils, Week 32, n=246, 263 Number Analyzed 246 participants 263 participants
0.144  (1.5739) 0.175  (1.5009)
Neutrophils, Week 36, n=250, 259 Number Analyzed 250 participants 259 participants
0.170  (1.3865) 0.243  (1.4938)
Neutrophils, Week 40, n=244, 245 Number Analyzed 244 participants 245 participants
0.055  (1.4372) 0.259  (1.4739)
Neutrophils, Week 44, n=249, 260 Number Analyzed 249 participants 260 participants
0.156  (1.5382) 0.273  (1.4445)
Neutrophils, Week 48, n=239, 258 Number Analyzed 239 participants 258 participants
0.110  (1.3697) 0.201  (1.3169)
Platelets, Week 4, n=278, 269 Number Analyzed 278 participants 269 participants
5.7  (29.10) 4.3  (31.11)
Platelets, Week 8, n=207, 273 Number Analyzed 207 participants 273 participants
-0.9  (29.09) 2.2  (35.14)
Platelets, Week 12, n=269, 271 Number Analyzed 269 participants 271 participants
0.8  (32.49) 6.2  (36.23)
Platelets, Week 16, n=251, 263 Number Analyzed 251 participants 263 participants
1.6  (33.34) 9.3  (51.53)
Platelets, Week 20, n=255, 264 Number Analyzed 255 participants 264 participants
7.6  (38.18) 13.4  (39.24)
Platelets, Week 24, n=256, 261 Number Analyzed 256 participants 261 participants
6.5  (36.11) 14.4  (35.15)
Platelets, Week 28, n=245, 258 Number Analyzed 245 participants 258 participants
8.6  (38.23) 18.4  (38.56)
Platelets, Week 32, n=249, 262 Number Analyzed 249 participants 262 participants
7.9  (40.22) 14.6  (34.28)
Platelets, Week 36, n=248, 259 Number Analyzed 248 participants 259 participants
12.1  (38.48) 18.6  (35.81)
Platelets, Week 40, n=244, 254 Number Analyzed 244 participants 254 participants
8.2  (36.08) 17.7  (43.30)
Platelets, Week 44, n=254, 261 Number Analyzed 254 participants 261 participants
9.4  (38.42) 19.3  (47.64)
Platelets, Week 48, n=240, 255 Number Analyzed 240 participants 255 participants
7.7  (39.61) 16.4  (47.45)
27.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 last available recorded value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
-0.7  (1.66) 0.2  (1.56)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
-2.5  (2.33) 0.2  (2.06)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
-3.8  (2.49) -0.3  (2.48)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
-5.1  (2.63) -0.2  (2.65)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
-5.6  (2.72) -0.5  (2.55)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
-5.6  (2.85) -0.5  (2.58)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
-5.6  (2.97) -0.9  (2.52)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
-5.3  (3.02) -0.9  (2.55)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
-5.3  (3.00) -0.6  (2.45)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
-4.8  (3.02) -0.1  (2.64)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
-4.2  (3.12) 0.2  (2.81)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
-3.7  (3.12) 1.0  (2.93)
28.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 last available recorded value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per Liter
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
0.08  (0.226) -0.03  (0.228)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
0.18  (0.249) 0.02  (0.239)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
0.23  (0.269) 0.01  (0.273)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
0.30  (0.263) 0.01  (0.255)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
0.31  (0.272) -0.01  (0.242)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
0.31  (0.254) 0.02  (0.242)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
0.29  (0.248) 0.04  (0.259)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
0.25  (0.283) 0.01  (0.259)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
0.23  (0.263) -0.01  (0.250)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
0.23  (0.246) -0.01  (0.239)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
0.21  (0.234) -0.06  (0.243)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
0.16  (0.264) -0.06  (0.257)
29.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 last available recorded value up to and including the date of first Maintenance phase dose of IP. 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
0.0046  (0.02082) -0.0013  (0.02213)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
0.0053  (0.02344) 0.0026  (0.02314)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
0.0040  (0.02383) -0.0000  (0.02618)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
0.0035  (0.02338) -0.0003  (0.02489)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
0.0024  (0.02335) -0.0033  (0.02323)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
0.0021  (0.02299) -0.0012  (0.02337)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
-0.0003  (0.02262) -0.0001  (0.02460)
Week 32, n=254, 267 Number Analyzed 254 participants 267 participants
-0.0017  (0.02607) -0.0032  (0.02503)
Week 36, n=252, 261 Number Analyzed 252 participants 261 participants
-0.0041  (0.02515) -0.0032  (0.02407)
Week 40, n=246, 255 Number Analyzed 246 participants 255 participants
-0.0014  (0.02461) -0.0017  (0.02388)
Week 44, n=256, 262 Number Analyzed 256 participants 262 participants
-0.0011  (0.02230) -0.0045  (0.02328)
Week 48, n=243, 260 Number Analyzed 243 participants 260 participants
-0.0027  (0.02571) -0.0019  (0.02572)
30.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 last available recorded value up to and including the date of first Maintenance Phase dose of IP. 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) ABC/ DTG/ 3TC
Hide Arm/Group Description:
Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue 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 (LTFU) period.
During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Number of Participants Analyzed 283 283
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Week 4, n=279, 273 Number Analyzed 279 participants 273 participants
1.8  (6.59) 0.1  (6.47)
Week 8, n=211, 275 Number Analyzed 211 participants 275 participants
1.9  (7.29) 1.3  (7.26)
Week 12, n=270, 275 Number Analyzed 270 participants 275 participants
2.1  (7.47) 1.5  (8.28)
Week 16, n=254, 265 Number Analyzed 254 participants 265 participants
2.9  (6.98) 1.4  (7.88)
Week 20, n=255, 267 Number Analyzed 255 participants 267 participants
2.9  (7.43) 1.4  (7.18)
Week 24, n=259, 264 Number Analyzed 259 participants 264 participants
2.7  (7.32) 2.0  (7.11)
Week 28, n=246, 265 Number Analyzed 246 participants 265 participants
2.7  (6.80) 3.3  (7.75)