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Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

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ClinicalTrials.gov Identifier: NCT03299049
Recruitment Status : Active, not recruiting
First Posted : October 2, 2017
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Janssen Research and Development
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 Tablets
Drug: Rilpivirine Tablets
Drug: Cabotegravir Injectable Suspension
Drug: Rilpivirine Injectable Suspension
Enrollment 1049
Recruitment Details This non-inferiority study evaluated antiviral activity of cabotegravir(CAB) long acting(LA) 600 milligrams(mg) + rilpivirine(RPV) LA 900 mg administered every 8 weeks(Q8W) compared with CAB LA 400 mg+RPV LA 600 mg administered every 4 weeks(Q4W) over a 48-week period in virologically suppressed human immunodeficiency type 1 infection participants.
Pre-assignment Details A total of 1049 eligible participants were randomized in a ratio of 1:1 to 1 of the 2 treatment arms in Maintenance Phase, of which 4 participants did not receive study treatment and 1045 participants were included in Intent to treat-Exposed Population. Results presented are based on Week 48 primary analysis.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter. Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Period Title: Overall Study
Started 522 523
Completed 0 0
Not Completed 522 523
Reason Not Completed
On-going             486             481
Withdrawal by Subject             6             21
Physician Decision             5             1
Lost to Follow-up             2             0
Pregnancy             1             3
Protocol Violation             1             1
Lack of Efficacy             9             3
Adverse Event             12             13
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W Total
Hide Arm/Group Description Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter. Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1. Total of all reporting groups
Overall Number of Baseline Participants 522 523 1045
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 522 participants 523 participants 1045 participants
42.7  (11.16) 42.3  (10.58) 42.5  (10.87)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 522 participants 523 participants 1045 participants
Sex at birth=Female 137 143 280
Sex at birth=Male 385 380 765
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 523 participants 1045 participants
Reported gender=Female
142
  27.2%
146
  27.9%
288
  27.6%
Reported gender=Male
380
  72.8%
377
  72.1%
757
  72.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 522 participants 523 participants 1045 participants
American Indian (AI) or Alaska Native (AN) 17 11 28
Asian-Central/South Asian Heritage (H) 1 1 2
Asian-East Asian H 20 12 32
Asian-Japanese H 0 2 2
Asian-South East Asian (SEA) H 8 7 15
Black or African American (AA) 101 90 191
Native Hawaiian (NH) or other Pacific Islander 3 1 4
White-Arabic/North African H 2 4 6
White-White/Caucasian/European (EU) H 368 388 756
White-Mixed White Race 0 1 1
Multiple-AI/AN and Black/AA/White/Caucasian/EU H 1 1 2
Multiple-AI/AN and NH/Other Pacific Islander 1 0 1
Multiple-SEA H and White/Caucasian/ EU H 0 1 1
Multiple-Black/AA and White-Arabic/North African H 0 1 1
Multiple-Black/AA and White/Caucasian/EU H 0 3 3
1.Primary Outcome
Title Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48
Hide Description Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Number
Unit of Measure: Percentage of participants
1.7 1.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB LA + RPV LA Q8W, CAB LA + RPV LA Q4W
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.
Method of Estimation Estimation Parameter Adjusted difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.6 to 2.2
Estimation Comments Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 >=50 c/mL between each treatment group (Q8W - Q4W) and corresponding 95% CI is presented.
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 48
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
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 Q8W, CAB LA + RPV LA Q4W
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%
Method of Estimation Estimation Parameter Adjusted difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-2.1 to 3.7
Estimation Comments Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 <50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 24
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95
(93 to 97)
95
(94 to 97)
4.Secondary Outcome
Title Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) Through Weeks 24 and 48
Hide Description CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL. Cumulative percentage of participants with protocol defined CVF up to Weeks 24 and 48 has been presented.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24 1.3 0.2
Week 48 1.5 0.4
5.Secondary Outcome
Title Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm at Week 24
Hide Description Percentage of participants with plasma HIV-1 RNA >=50 c/mL at Week 24 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI).
Time Frame Weeks 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.1
(0.9 to 3.3)
1.5
(0.5 to 2.6)
6.Secondary Outcome
Title Absolute Values for HIV-1 RNA at Week 48
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Time Frame Weeks 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 493 487
Mean (Standard Deviation)
Unit of Measure: Log 10 c/mL
1.599  (0.0870) 1.593  (0.0302)
7.Secondary Outcome
Title Change From Baseline Values for HIV-1 RNA at Week 48
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented.
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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 493 487
Mean (Standard Deviation)
Unit of Measure: Log 10 c/mL
0.007  (0.0888) -0.015  (0.1673)
8.Secondary Outcome
Title Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48
Hide Description Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q8W.
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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 493 486
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
685.9  (261.70) 700.0  (278.18)
9.Secondary Outcome
Title Change From Baseline Values for CD4+ at Week 48
Hide Description Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q4W. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 493 486
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
5.3  (168.62) -24.6  (199.02)
10.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (Non-SAEs >=5% Incidence) and Serious Adverse Events (SAEs)-Maintenance Phase
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to actual treatment received.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Count of Participants
Unit of Measure: Participants
Any non-SAE (>=5%)
429
  82.2%
427
  81.6%
Any SAE
27
   5.2%
19
   3.6%
11.Secondary Outcome
Title Number of Participants With Severity of Adverse Events-Maintenance Phase
Hide Description Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
201
  38.5%
195
  37.3%
Grade 2
231
  44.3%
238
  45.5%
Grade 3
38
   7.3%
43
   8.2%
Grade 4
2
   0.4%
6
   1.1%
Grade 5
1
   0.2%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Hide Description Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, glomerular filtration rate (GFR) from creatinine adjusted for bovine serum albumin (BSA), glucose, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) calculation, lipase, phosphate, potassium, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 1
45
   8.6%
49
   9.4%
ALT, Grade 2
10
   1.9%
13
   2.5%
ALT, Grade 3
1
   0.2%
3
   0.6%
ALT, Grade 4
1
   0.2%
2
   0.4%
Albumin, Grade 1
1
   0.2%
0
   0.0%
Albumin, Grade 2
1
   0.2%
1
   0.2%
Albumin, Grade 3
0
   0.0%
0
   0.0%
Albumin, Grade 4
0
   0.0%
0
   0.0%
ALP, Grade 1
1
   0.2%
5
   1.0%
ALP, Grade 2
0
   0.0%
0
   0.0%
ALP, Grade 3
0
   0.0%
0
   0.0%
ALP, Grade 4
0
   0.0%
0
   0.0%
AST, Grade 1
32
   6.1%
44
   8.4%
AST, Grade 2
10
   1.9%
13
   2.5%
AST, Grade 3
2
   0.4%
4
   0.8%
AST, Grade 4
1
   0.2%
2
   0.4%
Bilirubin, Grade 1
27
   5.2%
25
   4.8%
Bilirubin, Grade 2
7
   1.3%
5
   1.0%
Bilirubin, Grade 3
1
   0.2%
1
   0.2%
Bilirubin, Grade 4
1
   0.2%
1
   0.2%
CO2, Grade 1
98
  18.8%
111
  21.2%
CO2, Grade 2
2
   0.4%
1
   0.2%
CO2, Grade 3
0
   0.0%
0
   0.0%
CO2, Grade 4
0
   0.0%
0
   0.0%
Cholesterol, Grade 1
50
   9.6%
52
   9.9%
Cholesterol, Grade 2
31
   5.9%
30
   5.7%
Cholesterol, Grade 3
2
   0.4%
3
   0.6%
Cholesterol, Grade 4
0
   0.0%
0
   0.0%
Creatinine Kinase, Grade 1
41
   7.9%
32
   6.1%
Creatinine Kinase, Grade 2
22
   4.2%
19
   3.6%
Creatinine Kinase, Grade 3
7
   1.3%
9
   1.7%
Creatinine Kinase, Grade 4
9
   1.7%
14
   2.7%
Creatinine, Grade 1
5
   1.0%
9
   1.7%
Creatinine, Grade 2
2
   0.4%
1
   0.2%
Creatinine, Grade 3
0
   0.0%
0
   0.0%
Creatinine, Grade 4
0
   0.0%
0
   0.0%
GFR from creatinine adjusted for BSA, Grade 1
0
   0.0%
0
   0.0%
GFR from creatinine adjusted for BSA, Grade 2
110
  21.1%
134
  25.6%
GFR from creatinine adjusted for BSA, Grade 3
15
   2.9%
19
   3.6%
GFR from creatinine adjusted for BSA, Grade 4
0
   0.0%
1
   0.2%
Glucose, Grade 1
84
  16.1%
87
  16.6%
Glucose, Grade 2
34
   6.5%
43
   8.2%
Glucose, Grade 3
3
   0.6%
5
   1.0%
Glucose, Grade 4
1
   0.2%
1
   0.2%
Hyperglycemia, Grade 1
80
  15.3%
77
  14.7%
Hyperglycemia, Grade 2
32
   6.1%
38
   7.3%
Hyperglycemia, Grade 3
2
   0.4%
5
   1.0%
Hyperglycemia, Grade 4
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 1
8
   1.5%
2
   0.4%
Hyperkalemia, Grade 2
0
   0.0%
1
   0.2%
Hyperkalemia, Grade 3
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 4
0
   0.0%
1
   0.2%
Hypernatremia, Grade 1
6
   1.1%
2
   0.4%
Hypernatremia, Grade 2
0
   0.0%
0
   0.0%
Hypernatremia, Grade 3
0
   0.0%
0
   0.0%
Hypernatremia, Grade 4
0
   0.0%
0
   0.0%
Hypoglycemia, Grade 1
11
   2.1%
13
   2.5%
Hypoglycemia, Grade 2
2
   0.4%
5
   1.0%
Hypoglycemia, Grade 3
1
   0.2%
0
   0.0%
Hypoglycemia, Grade 4
1
   0.2%
1
   0.2%
Hypokalemia, Grade 1
10
   1.9%
8
   1.5%
Hypokalemia, Grade 2
0
   0.0%
0
   0.0%
Hypokalemia, Grade 3
0
   0.0%
0
   0.0%
Hypokalemia, Grade 4
0
   0.0%
0
   0.0%
Hyponatremia, Grade 1
23
   4.4%
26
   5.0%
Hyponatremia, Grade 2
0
   0.0%
1
   0.2%
Hyponatremia, Grade 3
0
   0.0%
0
   0.0%
Hyponatremia, Grade 4
0
   0.0%
0
   0.0%
LDL Cholesterol calculation, Grade 1
40
   7.7%
41
   7.8%
LDL Cholesterol calculation, Grade 2
20
   3.8%
26
   5.0%
LDL Cholesterol calculation, Grade 3
9
   1.7%
4
   0.8%
LDL Cholesterol calculation, Grade 4
0
   0.0%
0
   0.0%
Lipase, Grade 1
40
   7.7%
44
   8.4%
Lipase, Grade 2
31
   5.9%
44
   8.4%
Lipase, Grade 3
13
   2.5%
4
   0.8%
Lipase, Grade 4
3
   0.6%
6
   1.1%
Phosphate, Grade 1
75
  14.4%
72
  13.8%
Phosphate, Grade 2
20
   3.8%
1
   0.2%
Phosphate, Grade 3
0
   0.0%
2
   0.4%
Phosphate, Grade 4
0
   0.0%
0
   0.0%
Potassium, Grade 1
18
   3.4%
10
   1.9%
Potassium, Grade 2
0
   0.0%
1
   0.2%
Potassium, Grade 3
0
   0.0%
0
   0.0%
Potassium, Grade 4
0
   0.0%
1
   0.2%
Sodium, Grade 1
29
   5.6%
28
   5.4%
Sodium, Grade 2
0
   0.0%
1
   0.2%
Sodium, Grade 3
0
   0.0%
0
   0.0%
Sodium, Grade 4
0
   0.0%
0
   0.0%
Triglycerides, Grade 1
51
   9.8%
42
   8.0%
Triglycerides, Grade 2
11
   2.1%
3
   0.6%
Triglycerides, Grade 3
4
   0.8%
2
   0.4%
Triglycerides, Grade 4
0
   0.0%
2
   0.4%
13.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
Hide Description The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. Severity grades were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin, Grade 1
9
   1.7%
4
   0.8%
Hemoglobin, Grade 2
1
   0.2%
3
   0.6%
Hemoglobin, Grade 3
2
   0.4%
4
   0.8%
Hemoglobin, Grade 4
0
   0.0%
0
   0.0%
Leukocytes, Grade 1
12
   2.3%
5
   1.0%
Leukocytes, Grade 2
0
   0.0%
0
   0.0%
Leukocytes, Grade 3
1
   0.2%
0
   0.0%
Leukocytes, Grade 4
0
   0.0%
0
   0.0%
Neutrophils, Grade 1
7
   1.3%
6
   1.1%
Neutrophils, Grade 2
8
   1.5%
5
   1.0%
Neutrophils, Grade 3
1
   0.2%
2
   0.4%
Neutrophils, Grade 4
2
   0.4%
1
   0.2%
Platelets, Grade 1
8
   1.5%
8
   1.5%
Platelets, Grade 2
1
   0.2%
1
   0.2%
Platelets, Grade 3
1
   0.2%
1
   0.2%
Platelets, Grade 4
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to withdrawal has been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Measure Type: Number
Unit of Measure: Percentage of participants
2 2
15.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Hide Description Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALT, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
-1.3  (11.11) 0.1  (14.01)
ALT, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.8  (21.28) 0.3  (15.65)
ALT, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
1.5  (47.60) -0.7  (12.29)
ALT, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
1.9  (63.03) -0.3  (13.39)
ALT, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-0.4  (12.60) 2.4  (33.72)
ALT, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
0.4  (13.50) 6.6  (112.13)
ALT, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
1.1  (16.39) 1.6  (18.61)
ALP, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
-5.5  (12.09) -2.1  (10.25)
ALP, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
-4.1  (13.07) -3.3  (11.31)
ALP, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
-4.8  (14.65) -4.2  (13.07)
ALP, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
-5.2  (16.04) -4.0  (13.42)
ALP, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-5.7  (17.14) -4.1  (14.95)
ALP, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
-5.9  (17.61) -3.9  (16.09)
ALP, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
-6.6  (17.18) -4.5  (15.02)
AST, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
-0.6  (13.25) -0.3  (18.47)
AST, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.6  (11.71) 0.0  (14.46)
AST, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
1.2  (24.79) -0.3  (16.58)
AST, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
1.6  (53.81) -0.2  (21.65)
AST, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-1.6  (8.84) 0.8  (34.81)
AST, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
-1.0  (10.14) 2.5  (66.54)
AST, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
-0.2  (12.48) -0.7  (16.12)
Creatinine kinase, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
30.2  (689.41) -29.3  (717.51)
Creatinine kinase, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
24.1  (479.84) -23.7  (682.90)
Creatinine kinase, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
30.6  (692.65) -4.7  (856.65)
Creatinine kinase, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
-13.6  (265.16) 31.1  (1198.22)
Creatinine kinase, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-23.3  (314.46) -5.8  (787.02)
Creatinine kinase, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
-12.5  (336.08) 34.2  (1288.66)
Creatinine kinase, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
17.9  (411.70) -2.9  (810.46)
16.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Hide Description Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
-0.5  (2.32) -0.2  (2.45)
Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
-0.3  (2.48) -0.1  (2.48)
Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
-0.3  (2.56) -0.4  (2.51)
Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
-0.0  (2.49) -0.2  (2.59)
Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-0.2  (2.63) -0.3  (2.68)
Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
0.1  (2.68) -0.3  (2.54)
Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
-0.2  (2.59) -0.2  (2.60)
17.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
0.4  (6.44) 0.1  (5.70)
Bilirubin, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.4  (5.68) 0.1  (5.39)
Bilirubin, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
0.5  (5.78) 0.2  (5.69)
Bilirubin, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
0.8  (9.42) 0.5  (5.23)
Bilirubin, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
0.5  (5.54) 0.4  (5.46)
Bilirubin, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
0.7  (6.00) 0.4  (5.77)
Bilirubin, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
0.4  (5.77) 0.7  (4.93)
Creatinine, Week 4, n=326, 521 Number Analyzed 326 participants 521 participants
0.89  (8.768) -0.36  (7.215)
Creatinine, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
-0.94  (8.638) -0.39  (8.191)
Creatinine, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
-0.24  (8.973) -0.03  (8.516)
Creatinine, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
0.22  (9.085) 0.94  (9.591)
Creatinine, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
1.01  (9.490) 2.09  (9.313)
Creatinine, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
1.02  (9.604) 2.05  (9.414)
Creatinine, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
1.30  (9.813) 2.30  (8.678)
18.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
CO2, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
-0.5  (2.29) -0.7  (2.32)
CO2, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
-0.8  (2.12) -0.8  (2.23)
CO2, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
-1.0  (2.31) -0.9  (2.33)
CO2, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
-0.7  (2.38) -0.7  (2.28)
CO2, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-0.9  (2.31) -0.8  (2.43)
CO2, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
-0.6  (2.33) -0.7  (2.44)
CO2, Week 48, n=493, 485 Number Analyzed 493 participants 485 participants
-0.4  (2.32) -0.4  (2.41)
Chloride, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
0.6  (2.19) 0.2  (2.35)
Chloride, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.3  (2.24) 0.2  (2.34)
Chloride, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
0.4  (2.30) 0.2  (2.40)
Chloride, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
0.1  (2.36) -0.1  (2.59)
Chloride, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
0.2  (2.34) 0.1  (2.64)
Chloride, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
-0.1  (2.46) 0.0  (2.36)
Chloride, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
-0.0  (2.25) -0.1  (2.46)
Phosphate, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
0.054  (0.182) 0.018  (0.167)
Phosphate, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.025  (0.177) 0.029  (0.160)
Phosphate, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
0.017  (0.181) 0.007  (0.172)
Phosphate, Week 24, n=505, 502 Number Analyzed 505 participants 502 participants
0.016  (0.170) -0.004  (0.168)
Phosphate, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-0.001  (0.183) 0.001  (0.172)
Phosphate, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
0.014  (0.180) 0.001  (0.170)
Phosphate, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
0.007  (0.169) 0.010  (0.157)
Potassium, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
0.03  (0.337) 0.03  (0.303)
Potassium, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.04  (0.317) 0.04  (0.331)
Potassium, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
0.03  (0.328) 0.03  (0.341)
Potassium, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
0.04  (0.338) 0.03  (0.321)
Potassium, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
0.04  (0.364) 0.00  (0.340)
Potassium, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
0.04  (0.351) 0.02  (0.334)
Potassium, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
0.04  (0.315) 0.03  (0.327)
Sodium, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
0.4  (2.02) 0.1  (2.11)
Sodium, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.1  (2.14) 0.2  (2.02)
Sodium, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
0.0  (2.00) -0.1  (2.01)
Sodium, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
-0.2  (2.07) -0.3  (2.20)
Sodium, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-0.1  (2.10) -0.1  (2.21)
Sodium, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
-0.3  (2.09) -0.2  (2.13)
Sodium, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
-0.4  (2.02) -0.3  (2.21)
Urea, Week 4, n=326, 520 Number Analyzed 326 participants 520 participants
0.24  (1.251) 0.19  (1.227)
Urea, Week 8, n=510, 515 Number Analyzed 510 participants 515 participants
0.07  (1.306) 0.19  (1.336)
Urea, Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
0.07  (1.372) 0.15  (1.320)
Urea, Week 24, n=505, 503 Number Analyzed 505 participants 503 participants
0.06  (1.298) 0.15  (1.270)
Urea, Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
0.11  (1.297) 0.16  (1.356)
Urea, Week 40, n=495, 490 Number Analyzed 495 participants 490 participants
0.18  (1.345) 0.21  (1.412)
Urea, Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
0.13  (1.350) 0.14  (1.457)
19.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, glucose, direct HDL cholesterol, LDL cholesterol calculation and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Cholesterol, Week 48, n=423, 408 Number Analyzed 423 participants 408 participants
0.023  (0.742) 0.075  (0.748)
Glucose, Week 48, n=478, 470 Number Analyzed 478 participants 470 participants
0.16  (0.907) 0.12  (1.208)
Direct HDL cholesterol, Week 48, n=423, 408 Number Analyzed 423 participants 408 participants
0.011  (0.292) -0.000  (0.288)
LDL cholesterol calculation, Week 48, n=415, 398 Number Analyzed 415 participants 398 participants
0.026  (0.629) 0.098  (0.585)
Triglycerides, Week 48, n=423, 408 Number Analyzed 423 participants 408 participants
-0.039  (0.790) -0.017  (0.880)
20.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Hide Description Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: milliliters/minute/1.73 square meter
Week 4, n=326, 521 Number Analyzed 326 participants 521 participants
-0.8  (9.05) 0.4  (7.91)
Week 8, n=508, 514 Number Analyzed 508 participants 514 participants
1.0  (9.07) 0.4  (8.62)
Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
-0.2  (9.08) -0.4  (9.01)
Week 24, n=503, 503 Number Analyzed 503 participants 503 participants
-0.7  (9.67) -1.7  (10.65)
Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
-1.7  (10.12) -3.0  (10.19)
Week 40, n=494, 489 Number Analyzed 494 participants 489 participants
-1.7  (9.92) -2.9  (9.95)
Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
-1.9  (9.96) -3.3  (9.79)
21.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Hide Description Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Units per liter
Week 4, n=326, 521 Number Analyzed 326 participants 521 participants
1.7  (28.76) 1.1  (22.67)
Week 8, n=510, 514 Number Analyzed 510 participants 514 participants
1.5  (23.82) 1.4  (24.74)
Week 16, n=515, 513 Number Analyzed 515 participants 513 participants
2.7  (33.41) 0.7  (18.82)
Week 24, n=503, 503 Number Analyzed 503 participants 503 participants
0.7  (19.71) 2.6  (34.49)
Week 32, n=499, 498 Number Analyzed 499 participants 498 participants
3.1  (35.20) -0.5  (21.91)
Week 40, n=494, 486 Number Analyzed 494 participants 486 participants
1.3  (23.35) 2.7  (30.95)
Week 48, n=493, 486 Number Analyzed 493 participants 486 participants
3.2  (53.46) 2.9  (42.61)
22.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Hide Description Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Basophils, Week 4, n=330, 516 Number Analyzed 330 participants 516 participants
0.006  (0.02751) 0.003  (0.02811)
Basophils, Week 8, n=506, 505 Number Analyzed 506 participants 505 participants
0.000  (0.02682) 0.002  (0.02699)
Basophils, Week 16, n=508, 507 Number Analyzed 508 participants 507 participants
-0.000  (0.02651) 0.001  (0.02929)
Basophils, Week 24, n=497, 495 Number Analyzed 497 participants 495 participants
0.002  (0.02809) 0.002  (0.02803)
Basophils, Week 32, n=489, 486 Number Analyzed 489 participants 486 participants
0.005  (0.02708) 0.003  (0.02988)
Basophils, Week 40, n=479, 472 Number Analyzed 479 participants 472 participants
0.004  (0.02716) 0.004  (0.02772)
Basophils, Week 48, n=486, 478 Number Analyzed 486 participants 478 participants
0.005  (0.02730) 0.003  (0.02926)
Eosinophils, Week 4, n=330, 516 Number Analyzed 330 participants 516 participants
0.031  (0.13775) 0.015  (0.15112)
Eosinophils, Week 8, n=506, 505 Number Analyzed 506 participants 505 participants
0.015  (0.14391) 0.012  (0.13314)
Eosinophils, Week 16, n=508, 507 Number Analyzed 508 participants 507 participants
0.001  (0.13474) 0.010  (0.13012)
Eosinophils, Week 24, n=497, 495 Number Analyzed 497 participants 495 participants
0.001  (0.13607) 0.009  (0.12836)
Eosinophils, Week 32, n=489, 486 Number Analyzed 489 participants 486 participants
0.005  (0.12762) 0.011  (0.13810)
Eosinophils, Week 40, n=479, 472 Number Analyzed 479 participants 472 participants
0.006  (0.13578) 0.009  (0.12297)
Eosinophils, Week 48, n=486, 478 Number Analyzed 486 participants 478 participants
0.001  (0.12444) 0.002  (0.12646)
Leukocytes, Week 4, n=331, 520 Number Analyzed 331 participants 520 participants
0.437  (1.5653) 0.335  (1.6343)
Leukocytes, Week 8, n=508, 507 Number Analyzed 508 participants 507 participants
0.110  (1.5863) 0.214  (1.6109)
Leukocytes, Week 16, n=509, 507 Number Analyzed 509 participants 507 participants
0.050  (1.4281) 0.139  (1.6384)
Leukocytes, Week 24, n=499, 497 Number Analyzed 499 participants 497 participants
0.148  (1.5229) 0.139  (1.6301)
Leukocytes, Week 32, n=491, 489 Number Analyzed 491 participants 489 participants
0.185  (1.5455) 0.111  (1.6454)
Leukocytes, Week 40, n=480, 476 Number Analyzed 480 participants 476 participants
0.177  (1.6601) 0.100  (1.8042)
Leukocytes, Week 48, n=488, 478 Number Analyzed 488 participants 478 participants
-0.007  (1.5561) -0.012  (1.6035)
Lymphocytes, Week 4, n=330, 516 Number Analyzed 330 participants 516 participants
0.187  (0.44013) 0.063  (0.42683)
Lymphocytes, Week 8, n=506, 505 Number Analyzed 506 participants 505 participants
0.040  (0.39452) 0.039  (0.44987)
Lymphocytes, Week 16, n=508, 507 Number Analyzed 508 participants 507 participants
0.060  (0.43470) 0.033  (0.44030)
Lymphocytes, Week 24, n=497, 495 Number Analyzed 497 participants 495 participants
0.081  (0.41863) 0.061  (0.46240)
Lymphocytes, Week 32, n=489, 486 Number Analyzed 489 participants 486 participants
0.119  (0.46387) 0.096  (0.45178)
Lymphocytes, Week 40, n=479, 472 Number Analyzed 479 participants 472 participants
0.126  (0.44614) 0.107  (0.50590)
Lymphocytes, Week 48, n=486, 478 Number Analyzed 486 participants 478 participants
0.063  (0.43255) 0.049  (0.48991)
Monocytes, Week 4, n=330, 516 Number Analyzed 330 participants 516 participants
0.051  (0.14208) 0.021  (0.13359)
Monocytes, Week 8, n=506, 505 Number Analyzed 506 participants 505 participants
0.003  (0.12080) 0.003  (0.14270)
Monocytes, Week 16, n=508, 507 Number Analyzed 508 participants 507 participants
-0.002  (0.12804) -0.007  (0.14361)
Monocytes, Week 24, n=497, 495 Number Analyzed 497 participants 495 participants
0.019  (0.13460) 0.020  (0.14458)
Monocytes, Week 32, n=489, 486 Number Analyzed 489 participants 486 participants
0.048  (0.13969) 0.039  (0.14531)
Monocytes, Week 40, n=479, 472 Number Analyzed 479 participants 472 participants
0.060  (0.13570) 0.060  (0.15692)
Monocytes, Week 48, n=486, 478 Number Analyzed 486 participants 478 participants
0.030  (0.13329) 0.033  (0.13116)
Neutrophils, Week 4, n=330, 516 Number Analyzed 330 participants 516 participants
0.152  (1.44916) 0.228  (1.48979)
Neutrophils, Week 8, n=506, 505 Number Analyzed 506 participants 505 participants
0.035  (1.49397) 0.141  (1.48054)
Neutrophils, Week 16, n=508, 507 Number Analyzed 508 participants 507 participants
-0.018  (1.34384) 0.082  (1.52187)
Neutrophils, Week 24, n=497, 495 Number Analyzed 497 participants 495 participants
0.047  (1.36697) 0.027  (1.46192)
Neutrophils, Week 32, n=489, 486 Number Analyzed 489 participants 486 participants
0.001  (1.43051) -0.054  (1.53192)
Neutrophils, Week 40, n=479, 472 Number Analyzed 479 participants 472 participants
-0.021  (1.53092) -0.090  (1.58850)
Neutrophils, Week 48, n=486, 478 Number Analyzed 486 participants 478 participants
-0.108  (1.39875) -0.118  (1.37189)
Platelets, Week 4, n=329, 518 Number Analyzed 329 participants 518 participants
2.09  (32.330) 5.91  (39.613)
Platelets, Week 8, n=506, 507 Number Analyzed 506 participants 507 participants
-0.62  (35.873) 0.27  (34.345)
Platelets, Week 16, n=498, 505 Number Analyzed 498 participants 505 participants
0.01  (35.207) -1.70  (34.072)
Platelets, Week 24, n=496, 496 Number Analyzed 496 participants 496 participants
0.26  (36.085) -2.53  (35.214)
Platelets, Week 32, n=487, 486 Number Analyzed 487 participants 486 participants
1.67  (40.601) -1.76  (37.490)
Platelets, Week 40, n=478, 472 Number Analyzed 478 participants 472 participants
0.38  (38.636) 0.32  (38.028)
Platelets, Week 48, n=489, 474 Number Analyzed 489 participants 474 participants
0.06  (39.549) -1.51  (35.440)
23.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Hide Description Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Week 4, n=331, 520 Number Analyzed 331 participants 520 participants
-0.32  (2.136) -0.13  (2.322)
Week 8, n=509, 510 Number Analyzed 509 participants 510 participants
-1.16  (3.270) -0.84  (3.132)
Week 16, n=509, 507 Number Analyzed 509 participants 507 participants
-1.99  (4.583) -1.84  (4.370)
Week 24, n=500, 498 Number Analyzed 500 participants 498 participants
-2.46  (5.085) -2.41  (4.777)
Week 32, n=491, 491 Number Analyzed 491 participants 491 participants
-3.17  (5.005) -2.75  (4.682)
Week 40, n=481, 476 Number Analyzed 481 participants 476 participants
-3.35  (4.740) -3.15  (4.578)
Week 48, n=489, 478 Number Analyzed 489 participants 478 participants
-3.28  (5.000) -3.08  (4.797)
24.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Hide Description Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
Week 4, n=331, 520 Number Analyzed 331 participants 520 participants
0.033  (0.2206) 0.024  (0.2211)
Week 8, n=509, 510 Number Analyzed 509 participants 510 participants
0.092  (0.2669) 0.083  (0.2651)
Week 16, n=509, 507 Number Analyzed 509 participants 507 participants
0.182  (0.3050) 0.162  (0.3222)
Week 24, n=500, 498 Number Analyzed 500 participants 498 participants
0.209  (0.3071) 0.170  (0.3225)
Week 32, n=491, 491 Number Analyzed 491 participants 491 participants
0.189  (0.3145) 0.150  (0.3337)
Week 40, n=481, 476 Number Analyzed 481 participants 476 participants
0.229  (0.3217) 0.157  (0.3184)
Week 48, n=489, 478 Number Analyzed 489 participants 478 participants
0.188  (0.3288) 0.170  (0.3329)
25.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hematocrit Over Time
Hide Description Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Week 4, n=331, 520 Number Analyzed 331 participants 520 participants
0.002  (0.02088) 0.002  (0.02202)
Week 8, n=509, 510 Number Analyzed 509 participants 510 participants
0.004  (0.02274) 0.004  (0.02362)
Week 16, n=509, 507 Number Analyzed 509 participants 507 participants
0.008  (0.02290) 0.007  (0.02485)
Week 24, n=500, 498 Number Analyzed 500 participants 498 participants
0.008  (0.02219) 0.004  (0.02413)
Week 32, n=491, 491 Number Analyzed 491 participants 491 participants
0.003  (0.02352) 0.001  (0.02469)
Week 40, n=481, 476 Number Analyzed 481 participants 476 participants
0.006  (0.02323) 0.000  (0.02378)
Week 48, n=489, 478 Number Analyzed 489 participants 478 participants
0.003  (0.02414) 0.001  (0.02565)
26.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Hide Description Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Week 4, n=331, 520 Number Analyzed 331 participants 520 participants
0.08  (6.425) -0.16  (6.797)
Week 8, n=509, 510 Number Analyzed 509 participants 510 participants
0.28  (7.028) -0.05  (7.419)
Week 16, n=509, 507 Number Analyzed 509 participants 507 participants
0.44  (6.979) 0.05  (7.531)
Week 24, n=501, 498 Number Analyzed 501 participants 498 participants
1.48  (7.013) 0.45  (7.488)
Week 32, n=491, 491 Number Analyzed 491 participants 491 participants
1.11  (7.633) 0.05  (8.041)
Week 40, n=481, 476 Number Analyzed 481 participants 476 participants
1.36  (7.503) -0.47  (7.788)
Week 48, n=489, 478 Number Analyzed 489 participants 478 participants
-0.13  (7.631) -0.80  (8.462)
27.Secondary Outcome
Title Number of Participants With Phenotypic Resistance- Maintenance Phase
Hide Description Phenotypic resistance (PR) was analyzed in participants who met CVF criteria. PR for following Baseline third agent drugs: Integrase inhibitors(INI): bictegravir (BIC), CAB, dolutegravir (DTG), elvitegravir (EVG), raltegravir(RAL); non-nucleoside reverse transcriptase inhibitors(NNRTI): delavirdine(DLV), efavirenz(EFV), etravirine(ETR), nevirapine(NVP), RPV; nucleoside reverse transcriptase inhibitor (NRTI): lamivudine(3TC), abacavir(ABC), emtricitabine(FTC), tenofovir(TDF), zidovudine(ZDV), stavudine(d4T), didanosine(ddI) and protease inhibitors(PI): atazanavir(ATV), darunavir(DRV), fosamprenavir(FPV), indinavir(IDV), lopinavir(LPV), nelfinavir(NFV), ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented. Phenotypic susceptibility was defined based on the fold change (FC) value: resistant (FC>clinical higher cutoff or biological cutoff), partially sensitive (FC<=clinical higher cutoff and > clinical lower cutoff), sensitive(FC<=clinical lower cutoff or biological cutoff)
Time Frame Up to Week 48 analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The CVF Population comprised of all participants in ITT-E population who met CVF criteria. 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 8 2
Measure Type: Count of Participants
Unit of Measure: Participants
INI, BIC, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
INI, BIC, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
6
 100.0%
2
 100.0%
INI, CAB, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
INI, CAB, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
INI, DTG, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
INI, DTG, partially sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
INI, DTG, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
6
 100.0%
2
 100.0%
INI, EVG, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
4
  66.7%
2
 100.0%
INI, EVG, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
2
  33.3%
0
   0.0%
INI, RAL, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
4
  66.7%
2
 100.0%
INI, RAL, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
2
  33.3%
0
   0.0%
NNRTI, DLV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
6
  85.7%
2
 100.0%
NNRTI, DLV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
1
  14.3%
0
   0.0%
NNRTI, EFV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
5
  71.4%
2
 100.0%
NNRTI, EFV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
2
  28.6%
0
   0.0%
NNRTI, ETR, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
2
 100.0%
NNRTI, ETR, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
4
  57.1%
0
   0.0%
NNRTI, ETR, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
3
  42.9%
0
   0.0%
NNRTI, NVP, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
6
  85.7%
2
 100.0%
NNRTI, NVP, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
1
  14.3%
0
   0.0%
NNRTI, RPV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
6
  85.7%
2
 100.0%
NNRTI, RPV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
1
  14.3%
0
   0.0%
NRTI, 3TC, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
1
  14.3%
1
  50.0%
NRTI, 3TC, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
6
  85.7%
1
  50.0%
NRTI, ABC, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ABC, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ABC, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
NRTI, FTC, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
1
  14.3%
1
  50.0%
NRTI, FTC, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
6
  85.7%
1
  50.0%
NRTI, TDF, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, TDF, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
1
  50.0%
NRTI, TDF, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
1
  50.0%
NRTI, ZDV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
2
 100.0%
NRTI, ZDV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
0
   0.0%
NRTI, d4T, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, d4T, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
NRTI, ddI, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ddI, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ddI, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, ATV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, ATV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, DRV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, DRV, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, DRV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, FPV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, FPV, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, FPV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, IDV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, IDV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, LPV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, LPV, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, LPV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, NFV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
1
  50.0%
PI, NFV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
1
  50.0%
PI, RTV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
1
  50.0%
PI, RTV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
1
  50.0%
PI, SQV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, SQV, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, SQV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
PI, TPV, resistant, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, TPV, partially sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
0
   0.0%
0
   0.0%
PI, TPV, sensitive, n=7, 2 Number Analyzed 7 participants 2 participants
7
 100.0%
2
 100.0%
28.Secondary Outcome
Title Number of Participants With Genotypic Resistance-Maintenance Phase
Hide Description Genotypic resistance was analyzed in participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following Baseline third agent drugs, INI: BIC, DTG, EVG, RAL; NNRTI: DLV, EFV, ETR, NVP, RPV; NRTI: 3TC, ABC, FTC, TDF, ZDV, d4T, ddI and PI: ATV, ATV/ritonavir (r), DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r and TPV/r in participants meeting CVF criteria has been presented.
Time Frame Up to Week 48 analysis
Hide Outcome Measure Data
Hide Analysis Population Description
CVF 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 Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 8 2
Measure Type: Count of Participants
Unit of Measure: Participants
INI, BIC, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
1
  16.7%
0
   0.0%
INI, BIC, resistance possible, n=6, 2 Number Analyzed 6 participants 2 participants
2
  33.3%
1
  50.0%
INI, BIC, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
INI, DTG, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
1
  16.7%
0
   0.0%
INI, DTG, resistance possible, n=6, 2 Number Analyzed 6 participants 2 participants
2
  33.3%
1
  50.0%
INI, DTG, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
INI, EVG, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
4
  66.7%
2
 100.0%
INI, EVG, resistance possible, n=6, 2 Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
INI, EVG, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
2
  33.3%
0
   0.0%
INI, RAL, resistant, n=6, 2 Number Analyzed 6 participants 2 participants
4
  66.7%
2
 100.0%
INI, RAL, resistance possible, n=6, 2 Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
INI, RAL, sensitive, n=6, 2 Number Analyzed 6 participants 2 participants
2
  33.3%
0
   0.0%
NNRTI, DLV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
1
  50.0%
NNRTI, DLV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
1
  50.0%
NNRTI, DLV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
4
  50.0%
0
   0.0%
NNRTI, EFV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
4
  50.0%
2
 100.0%
NNRTI, EFV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
0
   0.0%
NNRTI, EFV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
0
   0.0%
NNRTI, ETR, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
NNRTI, ETR, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
1
  50.0%
NNRTI, ETR, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
6
  75.0%
0
   0.0%
NNRTI, NVP, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
4
  50.0%
2
 100.0%
NNRTI, NVP, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
0
   0.0%
NNRTI, NVP, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
0
   0.0%
NNRTI, RPV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
6
  75.0%
1
  50.0%
NNRTI, RPV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NNRTI, RPV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
2
  25.0%
1
  50.0%
NRTI, 3TC, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
1
  12.5%
1
  50.0%
NRTI, 3TC, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, 3TC, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
7
  87.5%
1
  50.0%
NRTI, ABC, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ABC, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
NRTI, ABC, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
NRTI, FTC, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
1
  12.5%
1
  50.0%
NRTI, FTC, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, FTC, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
7
  87.5%
1
  50.0%
NRTI, TDF, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
NRTI, TDF, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, TDF, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
NRTI, ZDV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
NRTI, ZDV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ZDV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
NRTI, d4T, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
NRTI, d4T, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, d4T, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
NRTI, ddI, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
NRTI, ddI, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
1
  12.5%
0
   0.0%
NRTI, ddI, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
7
  87.5%
1
  50.0%
PI, ATV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
PI, ATV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, ATV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
PI, ATV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, ATV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
PI, ATV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
PI, DRV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, DRV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, DRV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
2
 100.0%
PI, FPV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, FPV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, FPV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
2
 100.0%
PI, IDV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, IDV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
PI, IDV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
PI, LPV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, LPV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, LPV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
2
 100.0%
PI, NFV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
PI, NFV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, NFV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
PI, RTV, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
PI, RTV, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, RTV, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
PI, SQV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, SQV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, SQV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
2
 100.0%
PI, TPV/r, resistant, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
1
  50.0%
PI, TPV/r, resistance possible, n=8, 2 Number Analyzed 8 participants 2 participants
0
   0.0%
0
   0.0%
PI, TPV/r, sensitive, n=8, 2 Number Analyzed 8 participants 2 participants
8
 100.0%
1
  50.0%
29.Secondary Outcome
Title Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 Without (w/o) Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Hide Description Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants without prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at indicated time point is analyzed.
Arm/Group Title CAB LA + RPV LA Q8W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Overall Number of Participants Analyzed 306
Measure Type: Count of Participants
Unit of Measure: Participants
Injectable LA HIV treatment Q4W
0
   0.0%
Injectable LA HIV treatment Q8W
300
  98.0%
Oral daily HIV treatment
4
   1.3%
No preference
2
   0.7%
30.Secondary Outcome
Title Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 With >=1 Weeks of Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Hide Description Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants with >=1 weeks of prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at indicated time point is analyzed.
Arm/Group Title CAB LA + RPV LA Q8W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Overall Number of Participants Analyzed 191
Measure Type: Count of Participants
Unit of Measure: Participants
Injectable LA HIV treatment Q4W
6
   3.1%
Injectable LA HIV treatment Q8W
179
  93.7%
Oral daily HIV treatment
4
   2.1%
No preference
2
   1.0%
31.Secondary Outcome
Title Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W Arm Only
Hide Description Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV participants received during the oral lead-in period. Number of participants who selected each of the responses based on their treatment preference is presented.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at indicated time point is analyzed.
Arm/Group Title CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 497
Measure Type: Count of Participants
Unit of Measure: Participants
Injectable LA HIV treatment Q4W
468
  94.2%
Injectable LA HIV treatment Q8W
0
   0.0%
Oral daily HIV treatment
16
   3.2%
No preference
13
   2.6%
32.Secondary Outcome
Title Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Hide Description The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions:LISAT, medication worries (MEDWO) and disclosure worries (DISWO). Total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. Last Observation Carried Forward (LOCF) was used as primary method of analysis. Data for participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame Baseline (Day 1) and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Without exposure, Week 24, n=318, 324 Number Analyzed 318 participants 324 participants
1.5  (14.87) -0.5  (18.00)
Without exposure, Week 48, n=319, 324 Number Analyzed 319 participants 324 participants
-0.8  (15.24) 0.6  (17.51)
With exposure, Week 24, n=192, 194 Number Analyzed 192 participants 194 participants
-0.8  (14.31) 0.8  (13.73)
With exposure, Week 48, n=192, 194 Number Analyzed 192 participants 194 participants
0.3  (14.03) -1.3  (14.50)
33.Secondary Outcome
Title Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Hide Description The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=[100 divided by (25 minus 5)]*(MEDWO minus 5). A response of 1 in MEDWO score shows medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame Baseline (Day 1) and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Without exposure, Week 24, n=318, 324 Number Analyzed 318 participants 324 participants
2.7  (16.53) 2.6  (15.61)
Without exposure, Week 48, n=319, 324 Number Analyzed 319 participants 324 participants
3.0  (15.87) 1.9  (15.97)
With exposure, Week 24, n=192, 194 Number Analyzed 192 participants 194 participants
0.7  (10.57) 1.7  (14.86)
With exposure, Week 48, n=192, 194 Number Analyzed 192 participants 194 participants
1.3  (8.82) 1.3  (17.95)
34.Secondary Outcome
Title Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Hide Description The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (25 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows disclosure worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame Baseline (Day 1) and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Without exposure, Week 24, n=317, 324 Number Analyzed 317 participants 324 participants
1.4  (25.58) 1.2  (23.18)
Without exposure, Week 48, n=318, 324 Number Analyzed 318 participants 324 participants
-0.5  (28.14) -0.5  (23.86)
With exposure, Week 24, n=192, 194 Number Analyzed 192 participants 194 participants
0.9  (21.13) 1.8  (24.20)
With exposure, Week 48, n=192, 194 Number Analyzed 192 participants 194 participants
-0.6  (24.11) 1.5  (26.84)
35.Secondary Outcome
Title Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
Hide Description The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame Baseline (Day 1) and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
4.63  (9.818) 4.44  (9.709)
Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
4.42  (10.351) 3.55  (10.224)
With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.55  (5.050) 0.55  (5.347)
With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.40  (5.242) -0.01  (6.521)
36.Secondary Outcome
Title Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
Hide Description HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame Baseline (Day 1) and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Item 1, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.3  (1.19) 0.3  (1.18)
Item 1, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.3  (1.23) 0.2  (1.27)
Item 1, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.1  (0.77) 0.0  (0.78)
Item 1, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.1  (0.81) 0.0  (0.90)
Item 2, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.0  (0.73) 0.1  (0.67)
Item 2, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.0  (0.78) 0.0  (0.65)
Item 2, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.0  (0.42) 0.1  (0.61)
Item 2, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.49) 0.1  (0.63)
Item 3, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.0  (1.42) 0.0  (1.49)
Item 3, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.0  (1.45) 0.0  (1.48)
Item 3, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.0  (0.82) 0.1  (1.03)
Item 3, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (1.05) 0.0  (1.20)
Item 4, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.3  (1.05) 0.3  (1.28)
Item 4, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.2  (1.20) 0.2  (1.28)
Item 4, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.1  (0.73) 0.0  (0.80)
Item 4, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.1  (0.73) 0.0  (0.98)
Item 5, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.7  (1.41) 0.6  (1.37)
Item 5, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.7  (1.36) 0.5  (1.42)
Item 5, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.0  (0.58) 0.1  (0.72)
Item 5, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.69) 0.0  (0.88)
Item 6, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.9  (1.72) 0.8  (1.71)
Item 6, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.8  (1.71) 0.8  (1.80)
Item 6, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.2  (0.96) 0.1  (0.90)
Item 6, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.1  (1.13) -0.1  (1.12)
Item 7, Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
0.3  (0.78) 0.2  (0.98)
Item 7, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.2  (0.94) 0.2  (0.92)
Item 7, With exposure, Week 24, n=191, 193 Number Analyzed 191 participants 193 participants
0.0  (0.55) 0.0  (0.70)
Item 7, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.1  (0.73) 0.1  (0.69)
Item 8, Without exposure, Week 24, n=318, 322 Number Analyzed 318 participants 322 participants
0.5  (1.31) 0.6  (1.30)
Item 8, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.5  (1.31) 0.5  (1.41)
Item 8, With exposure, Week 24, n=191, 194 Number Analyzed 191 participants 194 participants
0.1  (0.61) 0.1  (0.58)
Item 8, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.64) 0.0  (0.80)
Item 9, Without exposure, Week 24, n=319, 322 Number Analyzed 319 participants 322 participants
0.4  (1.16) 0.4  (1.30)
Item 9, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.4  (1.23) 0.3  (1.36)
Item 9, With exposure, Week 24, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.52) 0.0  (0.72)
Item 9, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.1  (0.55) 0.0  (0.85)
Item 10, Without exposure, Week 24, n=319, 322 Number Analyzed 319 participants 322 participants
0.8  (1.44) 0.9  (1.50)
Item 10, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.8  (1.52) 0.7  (1.63)
Item 10, With exposure, Week 24, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.78) 0.0  (0.67)
Item 10, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.79) 0.0  (0.77)
Item 11, Without exposure, Week 24, n=319, 322 Number Analyzed 319 participants 322 participants
0.4  (1.22) 0.4  (1.25)
Item 11, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
0.4  (1.26) 0.3  (1.31)
Item 11, With exposure, Week 24, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.73) 0.1  (0.65)
Item 11, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
0.0  (0.62) -0.1  (0.84)
Item 12, Without exposure, Week 24, n=319, 322 Number Analyzed 319 participants 322 participants
-0.4  (1.46) -0.4  (1.48)
Item 12, Without exposure, Week 48, n=319, 323 Number Analyzed 319 participants 323 participants
-0.3  (1.46) -0.5  (1.57)
Item 12, With exposure, Week 24, n=191, 194 Number Analyzed 191 participants 194 participants
-0.1  (0.92) 0.0  (0.92)
Item 12, With exposure, Week 48, n=191, 194 Number Analyzed 191 participants 194 participants
-0.1  (1.08) 0.0  (1.02)
37.Secondary Outcome
Title Total Treatment Satisfaction Change Score Using HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) at Week 48
Hide Description The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. LOCF was used as primary method of analysis. Total treatment satisfaction change score for participants who entered the current study from Q4W arm of ATLAS (NCT number: NCT02951052) and from either standard of care (SOC) arms of ATLAS or the new SOC participants) 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Q4W ATLAS, n=124, 125 Number Analyzed 124 participants 125 participants
29.1  (6.72) 24.7  (12.33)
SOC, n=380, 382 Number Analyzed 380 participants 382 participants
28.9  (7.68) 27.3  (9.50)
38.Secondary Outcome
Title Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Hide Description The PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 most unfavourable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a domain is calculated as mean of all items within the domain. Higher scores represent worse perception of injection. LOCF was used as primary method of analysis.
Time Frame Week 8 and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Bother of ISRs, Week 24, n=515, 515 Number Analyzed 515 participants 515 participants
-0.00  (0.459) -0.01  (0.509)
Bother of ISRs, Week 48, n=515, 515 Number Analyzed 515 participants 515 participants
-0.00  (0.531) 0.01  (0.543)
Leg Movement, Week 24, n=515, 514 Number Analyzed 515 participants 514 participants
-0.11  (0.804) -0.23  (0.809)
Leg Movement, Week 48, n=515, 514 Number Analyzed 515 participants 514 participants
-0.12  (0.818) -0.24  (0.789)
Sleep, Week 24, n=515, 514 Number Analyzed 515 participants 514 participants
-0.00  (0.772) -0.20  (0.793)
Sleep, Week 48, n=515, 514 Number Analyzed 515 participants 514 participants
-0.03  (0.814) -0.18  (0.804)
Acceptance, Week 24, n=514, 515 Number Analyzed 514 participants 515 participants
-0.13  (0.813) -0.13  (0.837)
Acceptance, Week 48, n=514, 515 Number Analyzed 514 participants 515 participants
-0.18  (0.829) -0.13  (0.880)
39.Secondary Outcome
Title Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
Hide Description The PIN questionnaire explores the bother of pain at the injection site and ISRs, anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection. LOCF was used as primary method of analysis.
Time Frame Week 8 and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Anxiety before, Week 24, n=515, 515 Number Analyzed 515 participants 515 participants
0.0  (0.83) -0.1  (0.85)
Anxiety before, Week 48, n=515, 515 Number Analyzed 515 participants 515 participants
-0.1  (0.82) -0.1  (0.85)
Pain, Week 24, n=515, 515 Number Analyzed 515 participants 515 participants
0.1  (0.83) 0.1  (0.84)
Pain, Week 48, n=515, 515 Number Analyzed 515 participants 515 participants
0.0  (0.85) 0.0  (0.84)
Satisfaction, Week 24, n=514, 515 Number Analyzed 514 participants 515 participants
0.1  (0.77) -0.0  (0.77)
Satisfaction, Week 48, n=514, 515 Number Analyzed 514 participants 515 participants
-0.0  (0.77) -0.0  (0.84)
Anxiety after, Week 24, n=514, 515 Number Analyzed 514 participants 515 participants
-0.0  (0.76) 0.0  (0.83)
Anxiety after, Week 48, n=514, 515 Number Analyzed 514 participants 515 participants
-0.1  (0.79) -0.1  (0.89)
Willingness, Week 24, n=514, 514 Number Analyzed 514 participants 514 participants
-0.1  (0.55) -0.1  (0.65)
Willingness, Week 48, n=514, 514 Number Analyzed 514 participants 514 participants
-0.0  (0.66) -0.1  (0.72)
40.Secondary Outcome
Title Change From Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Hide Description The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication were analyzed.Items on the scale are rated as 1-5 scores:1:not at all acceptable,2:not very acceptable,3:somewhat acceptable, 4:totally acceptable and 5:I don't know.Total score of the dimension is calculated as the mean of recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:Total Score=(mean of the recoded items in the dimension minus1)divided by2*100. LOCF was used as primary method of analysis. Data for participants without or with prior exposure has been presented. Baseline value is defined as last available value up to and including the Maintenance treatment. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame Baseline (Day 1) and Weeks 24 and 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 (represented by n= X in the category titles).
Arm/Group Title CAB LA + RPV LA Q8W CAB LA + RPV LA Q4W
Hide Arm/Group Description:
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed 522 523
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Without exposure, Week 24, n=319, 323 Number Analyzed 319 participants 323 participants
6.0  (27.96) 4.0  (33.53)
Without exposure, Week 48, n=319, 324 Number Analyzed 319 participants 324 participants
6.9  (30.96) 5.6  (31.77)
With exposure, Week 24, n=192, 194 Number Analyzed 192 participants 194 participants
0.3  (21.37) -1.7  (21.79)
With exposure, Week 48, n=192, 194 Number Analyzed 192 participants 194 participants
-0.1  (24.92) -2.7  (24.25)
41.Secondary Outcome
Title Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Hide Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK Population comprises of all participants who received CAB and / or RPV and underwent PK sampling during the study and provide at least 1 non-missing CAB and / or RPV plasma concentration value (Non-quantifiable [NQ