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Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

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ClinicalTrials.gov Identifier: NCT03639311
Recruitment Status : Active, not recruiting
First Posted : August 21, 2018
Results First Posted : January 15, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: CAB LA
Drug: RPV LA
Drug: RPV
Drug: DTG
Enrollment 97
Recruitment Details This was a multicenter, open-label, rollover study evaluating the efficacy, safety and tolerability of long acting (LA) cabotegravir (CAB) plus LA rilpivirine (RPV) administered every 2 months (Q2M) in human immunodeficiency virus-1 (HIV-1) adult participants who were virologically suppressed and participated in study LAI116482 (NCT01641809).
Pre-assignment Details A total of 97 participants were enrolled in the study. The results presented are based on the Month 12 primary analysis. Data collection is still on-going and additional results will be provided after study completion analysis.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA. Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Period Title: Overall Study
Started 90 7
Completed 0 7
Not Completed 90 0
Reason Not Completed
Ongoing at the time of analysis             88             0
Lost to Follow-up             1             0
Adverse Event             1             0
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV Total
Hide Arm/Group Description Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA. Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Total of all reporting groups
Overall Number of Baseline Participants 90 7 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Overall Study Number Analyzed 90 participants 7 participants 97 participants
41.2  (9.49) 49.1  (11.42) 41.7  (9.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 7 participants 97 participants
Female
2
   2.2%
0
   0.0%
2
   2.1%
Male
88
  97.8%
7
 100.0%
95
  97.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 7 participants 97 participants
American Indian or Alaska Native
1
   1.1%
0
   0.0%
1
   1.0%
Asian-Japanese/East Asian/South East Asian Heritage
1
   1.1%
0
   0.0%
1
   1.0%
Black or African American
21
  23.3%
3
  42.9%
24
  24.7%
White
63
  70.0%
4
  57.1%
67
  69.1%
Multiple
4
   4.4%
0
   0.0%
4
   4.1%
1.Primary Outcome
Title Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12
Hide Description Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (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 12 months analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0.0 to 4.0)
0
(0.0 to 41.0)
2.Secondary Outcome
Title Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12
Hide Description Percentage of participants with HIV-1 RNA <50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98
(95 to 100)
100
(59 to 100)
3.Secondary Outcome
Title Percentage of Participants With Protocol-defined Confirmed Virologic Failure Overtime
Hide Description Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Time Frame Up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
4.Secondary Outcome
Title Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm
Hide Description Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen 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 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline (Day 1)
0
(0.0 to 4.0)
Month 2
0
(0.0 to 4.0)
Month 4
1
(0.0 to 3.3)
Month 6
0
(0.0 to 4.0)
Month 8
0
(0.0 to 4.0)
Month 10
0
(0.0 to 4.0)
Month 12
0
(0.0 to 4.0)
5.Secondary Outcome
Title Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV
Hide Description Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen 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 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline (Day 1)
0.0
(0.0 to 41.0)
Month 3
0.0
(0.0 to 41.0)
Month 6
0.0
(0.0 to 41.0)
Month 9
0.0
(0.0 to 41.0)
Month 12
0.0
(0.0 to 41.0)
6.Secondary Outcome
Title Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Baseline (Day 1), n=89 Number Analyzed 89 participants
1.591  (0.0085)
Month 2, n=90 Number Analyzed 90 participants
1.590  (0.0000)
Month 4, n=89 Number Analyzed 89 participants
1.594  (0.0305)
Month 6, n=89 Number Analyzed 89 participants
1.590  (0.0042)
Month 8, n=89 Number Analyzed 89 participants
1.590  (0.0000)
Month 10, n=88 Number Analyzed 88 participants
1.594  (0.0384)
Month 12, n=88 Number Analyzed 88 participants
1.590  (0.0000)
7.Secondary Outcome
Title Absolute Values for HIV-1 RNA of DTG + RPV Arm
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. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Baseline (Day 1) 1.590  (0.0000)
Month 3 1.590  (0.0000)
Month 6 1.590  (0.0000)
Month 9 1.590  (0.0000)
Month 12 1.590  (0.0000)
8.Secondary Outcome
Title Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Month 2, n=89 Number Analyzed 89 participants
-0.001  (0.0085)
Month 4, n=88 Number Analyzed 88 participants
0.003  (0.0299)
Month 6, n=88 Number Analyzed 88 participants
-0.000  (0.0096)
Month 8, n=88 Number Analyzed 88 participants
-0.001  (0.0085)
Month 10, n=87 Number Analyzed 87 participants
0.003  (0.0396)
Month 12, n=87 Number Analyzed 87 participants
-0.001  (0.0086)
9.Secondary Outcome
Title Change From Baseline in HIV-1 RNA for DTG + RPV Arm
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame Baseline (Day 1) and at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Month 3 0.000  (0.0000)
Month 6 0.000  (0.0000)
Month 9 0.000  (0.0000)
Month 12 0.000  (0.0000)
10.Secondary Outcome
Title Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm
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 Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 2, 4, 6, 8, and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Baseline (Day 1), n=90 Number Analyzed 90 participants
873.0  (233.37)
Month 2, n= 90 Number Analyzed 90 participants
868.1  (261.49)
Month 4, n= 88 Number Analyzed 88 participants
879.8  (280.88)
Month 6, n= 5 Number Analyzed 5 participants
1046.8  (435.74)
Month 8, n= 88 Number Analyzed 88 participants
857  (277.46)
Month 12, n= 88 Number Analyzed 88 participants
859.2  (283.23)
11.Secondary Outcome
Title Absolute Values for CD4+ for DTG + RPV Arm
Hide Description Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Baseline (Day 1) 804.3  (167.73)
Month 3 780.3  (145.22)
Month 6 728.9  (147.06)
Month 9 777.0  (251.37)
Month 12 790.4  (141.80)
12.Secondary Outcome
Title Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm
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 Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame Baseline (Day 1) and at Months 2, 4, 6, 8, and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Month 2, n= 90 Number Analyzed 90 participants
-4.9  (196.47)
Month 4, n= 88 Number Analyzed 88 participants
5.3  (221.68)
Month 6, n= 5 Number Analyzed 5 participants
100.2  (343.66)
Month 8, n= 88 Number Analyzed 88 participants
-20.7  (218.39)
Month 12, n= 88 Number Analyzed 88 participants
-19.4  (189.19)
13.Secondary Outcome
Title Change From Baseline Values for CD4+ for DTG + RPV Arm
Hide Description Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame Baseline (Day 1) and at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Month 3 -24.0  (118.40)
Month 6 -75.4  (123.71)
Month 9 -27.3  (150.96)
Month 12 -13.9  (145.76)
14.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs)
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 participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
Time Frame Up to Month 17
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Safety Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
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Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Count of Participants
Unit of Measure: Participants
Non-SAE (>=5%)
76
  84.4%
3
  42.9%
SAE
5
   5.6%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Severity of Adverse Events
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 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 Month 17
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Safety Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
33
  36.7%
0
   0.0%
Grade 2
44
  48.9%
3
  42.9%
Grade 3
6
   6.7%
0
   0.0%
Grade 4
3
   3.3%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Chemistry Toxicities
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, aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, 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 Month 12
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Safety Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 1
8
   8.9%
1
  14.3%
ALT, Grade 2
4
   4.4%
0
   0.0%
ALT, Grade 3
1
   1.1%
0
   0.0%
ALT, Grade 4
0
   0.0%
0
   0.0%
AST, Grade 1
8
   8.9%
0
   0.0%
AST, Grade 2
3
   3.3%
0
   0.0%
AST, Grade 3
0
   0.0%
0
   0.0%
AST, Grade 4
0
   0.0%
0
   0.0%
Bilirubin, Grade 1
2
   2.2%
0
   0.0%
Bilirubin, Grade 2
1
   1.1%
0
   0.0%
Bilirubin, Grade 3
0
   0.0%
0
   0.0%
Bilirubin, Grade 4
0
   0.0%
0
   0.0%
CO2, Grade 1
8
   8.9%
1
  14.3%
CO2, Grade 2
0
   0.0%
0
   0.0%
CO2, Grade 3
0
   0.0%
0
   0.0%
CO2, Grade 4
0
   0.0%
0
   0.0%
Cholesterol, Grade 1
6
   6.7%
0
   0.0%
Cholesterol, Grade 2
4
   4.4%
0
   0.0%
Cholesterol, Grade 3
0
   0.0%
0
   0.0%
Cholesterol, Grade 4
0
   0.0%
0
   0.0%
Creatine kinase, Grade 1
5
   5.6%
0
   0.0%
Creatine kinase, Grade 2
2
   2.2%
0
   0.0%
Creatine kinase, Grade 3
4
   4.4%
0
   0.0%
Creatine kinase, Grade 4
2
   2.2%
0
   0.0%
Creatinine, Grade 1
1
   1.1%
0
   0.0%
Creatinine, Grade 2
0
   0.0%
0
   0.0%
Creatinine, Grade 3
0
   0.0%
0
   0.0%
Creatinine, Grade 4
0
   0.0%
0
   0.0%
Direct bilirubin, Grade 1
0
   0.0%
0
   0.0%
Direct bilirubin, Grade 2
0
   0.0%
0
   0.0%
Direct bilirubin, Grade 3
1
   1.1%
0
   0.0%
Direct bilirubin, Grade 4
0
   0.0%
0
   0.0%
GFR from creatinine adjusted using CKD-EPI, Grade 1
0
   0.0%
0
   0.0%
GFR from creatinine adjusted using CKD-EPI, Grade 2
12
  13.3%
5
  71.4%
GFR from creatinine adjusted using CKD-EPI, Grade 3
1
   1.1%
1
  14.3%
GFR from creatinine adjusted using CKD-EPI, 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
12
  13.3%
5
  71.4%
GFR from creatinine adjusted for BSA, Grade 3
1
   1.1%
1
  14.3%
GFR from creatinine adjusted for BSA, Grade 4
0
   0.0%
0
   0.0%
Glucose, Grade 1
13
  14.4%
1
  14.3%
Glucose, Grade 2
12
  13.3%
0
   0.0%
Glucose, Grade 3
0
   0.0%
0
   0.0%
Glucose, Grade 4
0
   0.0%
0
   0.0%
LDL cholesterol calculation, Grade 1
6
   6.7%
0
   0.0%
LDL cholesterol calculation, Grade 2
3
   3.3%
0
   0.0%
LDL cholesterol calculation, Grade 3
0
   0.0%
0
   0.0%
LDL cholesterol calculation, Grade 4
0
   0.0%
0
   0.0%
Lipase, Grade 1
6
   6.7%
0
   0.0%
Lipase, Grade 2
5
   5.6%
2
  28.6%
Lipase, Grade 3
2
   2.2%
0
   0.0%
Lipase, Grade 4
1
   1.1%
0
   0.0%
Phosphate, Grade 1
6
   6.7%
0
   0.0%
Phosphate, Grade 2
1
   1.1%
0
   0.0%
Phosphate, Grade 3
0
   0.0%
0
   0.0%
Phosphate, Grade 4
0
   0.0%
0
   0.0%
Sodium, Grade 1
4
   4.4%
0
   0.0%
Sodium, Grade 2
0
   0.0%
0
   0.0%
Sodium, Grade 3
0
   0.0%
0
   0.0%
Sodium, Grade 4
0
   0.0%
0
   0.0%
Triglycerides, Grade 1
5
   5.6%
0
   0.0%
Triglycerides, Grade 2
4
   4.4%
0
   0.0%
Triglycerides, Grade 3
1
   1.1%
0
   0.0%
Triglycerides, Grade 4
1
   1.1%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Hematology Toxicities
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 parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame Up to Month 12
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Safety Population.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Count of Participants
Unit of Measure: Participants
Platelets, Grade 1
2
   2.2%
0
   0.0%
Platelets, Grade 2
0
   0.0%
0
   0.0%
Platelets, Grade 3
0
   0.0%
0
   0.0%
Platelets, Grade 4
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Percentage of Participants Who Permanently Discontinued Treatment Due to Adverse Events
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 permanent withdrawal has been presented.
Time Frame Up to Month 12
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Safety Population
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Measure Type: Number
Unit of Measure: Percentage of participants
1 0
19.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase Over Time for CAB LA + RPV LA Q2M Arm
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 at Months 2, 4, 8 and 12
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Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALT, Month 2, n=90 Number Analyzed 90 participants
-1.1  (16.99)
ALT, Month 4, n=89 Number Analyzed 89 participants
-1.0  (26.15)
ALT, Month 8, n=89 Number Analyzed 89 participants
0.0  (29.86)
ALT, Month 12, n=88 Number Analyzed 88 participants
4.0  (44.62)
ALP, Month 2, n=90 Number Analyzed 90 participants
0.2  (8.29)
ALP, Month 4, n=89 Number Analyzed 89 participants
0.2  (14.20)
ALP, Month 8, n=89 Number Analyzed 89 participants
2.0  (11.58)
ALP, Month 12, n=88 Number Analyzed 88 participants
2.1  (12.39)
AST, Month 2, n=90 Number Analyzed 90 participants
-5.6  (47.9)
AST, Month 4, n=89 Number Analyzed 89 participants
-5.0  (50.5)
AST, Month 8, n=89 Number Analyzed 89 participants
-5.3  (49.56)
AST, Month 12, n=88 Number Analyzed 88 participants
-2.7  (54.93)
Creatine kinase, Month 2, n=90 Number Analyzed 90 participants
-255.2  (2327.32)
Creatine kinase, Month 4, n=89 Number Analyzed 89 participants
-204.0  (2483.41)
Creatine kinase, Month 8, n=89 Number Analyzed 89 participants
-237.0  (2362.99)
Creatine kinase, Month 12, n=88 Number Analyzed 88 participants
-252.0  (2429.86)
20.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time for DTG + RPV Arm
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 at Months 3, 6, 9 and 12
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Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALT, Month 3 -0.7  (22.37)
ALT, Month 6 -4.3  (19.99)
ALT, Month 9 1.7  (8.16)
ALT, Month 12 -0.3  (32.32)
ALP, Month 3 1.4  (10.11)
ALP, Month 6 1.6  (8.04)
ALP, Month 9 -1.1  (11.74)
ALP, Month 12 10.0  (33.16)
AST, Month 3 -0.6  (10.61)
AST, Month 6 -3.3  (7.30)
AST, Month 9 -1.4  (6.68)
AST, Month 12 -0.6  (14.68)
Creatine kinase, Month 3 -66.6  (287.66)
Creatine kinase, Month 6 -107.9  (112.18)
Creatine kinase, Month 9 -90.6  (163.40)
Creatine kinase, Month 12 -134.0  (149.59)
21.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Month 2, n=90 Number Analyzed 90 participants
-0.8  (2.31)
Month 4, n=89 Number Analyzed 89 participants
-0.9  (2.46)
Month 8, n=89 Number Analyzed 89 participants
-0.8  (2.63)
Month 12, n=88 Number Analyzed 88 participants
-0.9  (2.67)
22.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for DTG+ RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Month 3 -1.6  (3.87)
Month 6 -1.4  (2.30)
Month 9 -1.3  (2.63)
Month 12 -2.6  (2.37)
23.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, Month 2, n=90 Number Analyzed 90 participants
-1.0  (4.33)
Bilirubin, Month 4, n=89 Number Analyzed 89 participants
-1.0  (5.14)
Bilirubin, Month 8, n=89 Number Analyzed 89 participants
-1.0  (4.83)
Bilirubin, Month 12, n=88 Number Analyzed 88 participants
-0.5  (4.35)
Creatinine, Month 2, n=90 Number Analyzed 90 participants
-1.84  (7.121)
Creatinine, Month 4, n=89 Number Analyzed 89 participants
-1.70  (9.393)
Creatinine, Month 8, n=89 Number Analyzed 89 participants
-0.98  (7.977)
Creatinine, Month 12, n=88 Number Analyzed 88 participants
-1.14  (9.204)
24.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for DTG+ RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 3, 6, 9 and 12
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 category titles).
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, Month 3, n=7 -1.7  (4.23)
Bilirubin, Month 6, n=7 -1.4  (3.21)
Bilirubin, Month 9, n=7 -0.9  (2.54)
Bilirubin, Month 12, n=7 -1.4  (3.78)
Creatinine, Month 3, n=7 11.89  (8.89)
Creatinine, Month 6, n=7 8.36  (4.419)
Creatinine, Month 9, n=7 16.56  (10.131)
Creatinine, Month 12, n=7 7.47  (7.328)
25.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Carbon dioxide, Month 2, n=90 Number Analyzed 90 participants
-0.4  (1.86)
Carbon dioxide, Month 4, n=89 Number Analyzed 89 participants
-0.1  (2.00)
Carbon dioxide, Month 8, n=89 Number Analyzed 89 participants
-0.2  (2.22)
Carbon dioxide, Month 12, n=88 Number Analyzed 88 participants
-0.7  (2.18)
Chloride, Month 2, n=90 Number Analyzed 90 participants
1.0  (2.06)
Chloride, Month 4, n=89 Number Analyzed 89 participants
1.1  (2.20)
Chloride, Month 8, n=89 Number Analyzed 89 participants
1.2  (2.07)
Chloride, Month 12, n=88 Number Analyzed 88 participants
1.0  (2.24)
Glucose, Month 2, n=64 Number Analyzed 64 participants
0.32  (0.568)
Glucose, Month 4, n=62 Number Analyzed 62 participants
0.42  (0.684)
Glucose, Month 8, n=62 Number Analyzed 62 participants
0.47  (0.842)
Glucose, Month 12, n=87 Number Analyzed 87 participants
0.32  (0.662)
Phosphate, Month 2, n=90 Number Analyzed 90 participants
-0.00  (0.176)
Phosphate, Month 4, n=89 Number Analyzed 89 participants
-0.00  (0.191)
Phosphate, Month 8, n=89 Number Analyzed 89 participants
-0.02  (0.206)
Phosphate, Month 12, n=88 Number Analyzed 88 participants
-0.02  (0.199)
Potassium, Month 2, n=90 Number Analyzed 90 participants
0.06  (0.392)
Potassium, Month 4, n=89 Number Analyzed 89 participants
-0.02  (0.450)
Potassium, Month 8, n=89 Number Analyzed 89 participants
0.05  (0.408)
Potassium, Month 12, n=88 Number Analyzed 88 participants
0.06  (0.375)
Sodium, Month 2, n=90 Number Analyzed 90 participants
0.2  (1.84)
Sodium, Month 4, n=89 Number Analyzed 89 participants
0.6  (2.10)
Sodium, Month 8, n=89 Number Analyzed 89 participants
0.6  (1.96)
Sodium, Month 12, n=88 Number Analyzed 88 participants
0.2  (1.88)
Urea, Month 2, n=90 Number Analyzed 90 participants
0.13  (1.253)
Urea, Month 4, n=89 Number Analyzed 89 participants
-0.06  (1.346)
Urea, Month 8, n=89 Number Analyzed 89 participants
0.28  (1.131)
Urea, Month 12, n=88 Number Analyzed 88 participants
-0.11  (1.318)
26.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, 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 at Months 3, 6, 9 and 12
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 category titles).
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Carbon dioxide, Month 3, n=7 Number Analyzed 7 participants
-1.0  (1.53)
Carbon dioxide, Month 6, n=7 Number Analyzed 7 participants
-1.7  (1.50)
Carbon dioxide, Month 9, n=7 Number Analyzed 7 participants
-1.9  (2.85)
Carbon dioxide, Month 12, n=7 Number Analyzed 7 participants
-1.9  (2.48)
Chloride, Month 3, n=7 Number Analyzed 7 participants
1.0  (1.83)
Chloride, Month 6, n=7 Number Analyzed 7 participants
1.7  (2.14)
Chloride, Month 9, n=7 Number Analyzed 7 participants
1.0  (0.82)
Chloride, Month 12, n=7 Number Analyzed 7 participants
1.0  (2.08)
Glucose, Month 3, n=5 Number Analyzed 5 participants
0.08  (0.259)
Glucose, Month 6, n=5 Number Analyzed 5 participants
0.16  (0.483)
Glucose, Month 9, n=4 Number Analyzed 4 participants
0.15  (0.700)
Glucose, Month 12, n=7 Number Analyzed 7 participants
0.07  (0.55)
Phosphate, Month 3, n=7 Number Analyzed 7 participants
0.02  (0.131)
Phosphate, Month 6, n=7 Number Analyzed 7 participants
0.08  (0.177)
Phosphate, Month 9, n=7 Number Analyzed 7 participants
0.05  (0.178)
Phosphate, Month 12, n=7 Number Analyzed 7 participants
-0.05  (0.101)
Potassium, Month 3, n=7 Number Analyzed 7 participants
-0.26  (0.378)
Potassium, Month 6, n=7 Number Analyzed 7 participants
-0.03  (0.250)
Potassium, Month 9, n=7 Number Analyzed 7 participants
0.01  (0.135)
Potassium, Month 12, n=7 Number Analyzed 7 participants
-0.06  (0.257)
Sodium, Month 3, n=7 Number Analyzed 7 participants
0.1  (1.68)
Sodium, Month 6, n=7 Number Analyzed 7 participants
-0.9  (0.90)
Sodium, Month 9, n=7 Number Analyzed 7 participants
-1.0  (2.58)
Sodium, Month 12, n=7 Number Analyzed 7 participants
-1.1  (1.07)
Urea, Month 3, n=7 Number Analyzed 7 participants
1.43  (0.732)
Urea, Month 6, n=7 Number Analyzed 7 participants
1.14  (1.144)
Urea, Month 9, n=7 Number Analyzed 7 participants
1.86  (1.994)
Urea, Month 12, n=7 Number Analyzed 7 participants
0.71  (0.756)
27.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, LDL Cholesterol Direct and Triglycerides for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, direct HDL cholesterol, LDL cholesterol calculation, direct LDL cholesterol 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 at Month 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Cholesterol, n=88 Number Analyzed 88 participants
0.12  (0.760)
Direct HDL cholesterol, n=88 Number Analyzed 88 participants
-0.05  (0.224)
LDL cholesterol calculation, n=83 Number Analyzed 83 participants
0.10  (0.718)
Direct LDL cholesterol, n=2 Number Analyzed 2 participants
0.21  (0.367)
Triglycerides, n=88 Number Analyzed 88 participants
0.28  (1.965)
28.Secondary Outcome
Title Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.
Time Frame At Day 1
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 category titles).
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Cholesterol, n=7 Number Analyzed 7 participants
4.88  (1.352)
Direct HDL cholesterol, n=7 Number Analyzed 7 participants
1.59  (0.258)
LDL cholesterol calculation, n=6 Number Analyzed 6 participants
2.29  (0.52)
Direct LDL cholesterol, n=1 Number Analyzed 1 participants
4.45 [1]   (NA)
Triglycerides, n=7 Number Analyzed 7 participants
1.52  (1.493)
[1]
Standard deviation could not be calculated for single participant.
29.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Milliliter per minute per 1.73 meter^2
Month 2, n=90 Number Analyzed 90 participants
1.9  (7.70)
Month 4, n=89 Number Analyzed 89 participants
1.7  (10.09)
Month 8, n=88 Number Analyzed 88 participants
0.8  (8.63)
Month 12, n=88 Number Analyzed 88 participants
0.3  (10.32)
30.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Milliliter per minute per 1.73 meter^2
Month 3 -11.7  (10.83)
Month 6 -7.4  (4.28)
Month 9 -16.6  (12.27)
Month 12 -7.3  (8.71)
31.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Milliliter per second per 1.73 meter^2
Month 2, n=90 Number Analyzed 90 participants
0.03  (0.128)
Month 4, n=89 Number Analyzed 89 participants
0.02  (0.168)
Month 8, n=88 Number Analyzed 88 participants
0.01  (0.143)
Month 12, n=88 Number Analyzed 88 participants
0.00  (0.172)
32.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. 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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Milliliter per second per 1.73 meter^2
Month 3 -0.19  (0.180)
Month 6 -0.12  (0.071)
Month 9 -0.27  (0.204)
Month 12 -0.12  (0.145)
33.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Units per liter
Month 2, n=90 Number Analyzed 90 participants
-0.1  (29.11)
Month 4, n=89 Number Analyzed 89 participants
3.7  (47.68)
Month 8, n=89 Number Analyzed 89 participants
-1.3  (29.43)
Month 12, n=88 Number Analyzed 88 participants
-2.9  (36.83)
34.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical 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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Units per liter
Month 3 2.6  (6.90)
Month 6 4.4  (4.35)
Month 9 1.3  (6.85)
Month 12 26.0  (49.76)
35.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. 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 at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: Ratio
0.20  (1.698)
36.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. 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 at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: Ratio
0.55  (0.679)
37.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm
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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Basophils, Month 2, n=85 Number Analyzed 85 participants
-0.000  (0.02200)
Basophils, Month 4, n=82 Number Analyzed 82 participants
0.009  (0.02913)
Basophils, Month 8, n=86 Number Analyzed 86 participants
0.003  (0.02524)
Basophils, Month 12, n=86 Number Analyzed 86 participants
-0.003  (0.02501)
Eosinophils, Month 2, n=85 Number Analyzed 85 participants
0.017  (0.11886)
Eosinophils, Month 4, n=82 Number Analyzed 82 participants
0.004  (0.12341)
Eosinophils, Month 8, n=86 Number Analyzed 86 participants
0.003  (0.14555)
Eosinophils, Month 12, n=86 Number Analyzed 86 participants
-0.000  (0.13671)
Leukocytes, Month 2, n=85 Number Analyzed 85 participants
-0.054  (1.1875)
Leukocytes, Month 4, n=82 Number Analyzed 82 participants
0.276  (1.4416)
Leukocytes, Month 8, n=86 Number Analyzed 86 participants
0.257  (1.4252)
Leukocytes, Month 12, n=86 Number Analyzed 86 participants
-0.153  (1.1961)
Lymphocytes, Month 2, n=88 Number Analyzed 88 participants
0.196  (0.49569)
Lymphocytes, Month 4, n=86 Number Analyzed 86 participants
0.178  (0.52066)
Lymphocytes, Month 8, n=86 Number Analyzed 86 participants
0.139  (0.50957)
Lymphocytes, Month 12, n=86 Number Analyzed 86 participants
0.021  (0.60569)
Monocytes, Month 2, n=85 Number Analyzed 85 participants
0.022  (0.11715)
Monocytes, Month 4, n=82 Number Analyzed 82 participants
0.048  (0.14689)
Monocytes, Month 8, n=86 Number Analyzed 86 participants
0.026  (0.16979)
Monocytes, Month 12, n=86 Number Analyzed 86 participants
-0.021  (0.15241)
Neutrophils, Month 2, n=85 Number Analyzed 85 participants
-0.197  (0.99349)
Neutrophils, Month 4, n=82 Number Analyzed 82 participants
0.056  (1.19574)
Neutrophils, Month 8, n=86 Number Analyzed 86 participants
0.120  (1.18605)
Neutrophils, Month 12, n=86 Number Analyzed 86 participants
-0.134  (1.03311)
Platelets, Month 2, n=82 Number Analyzed 82 participants
3.77  (23.389)
Platelets, Month 4, n=81 Number Analyzed 81 participants
5.40  (30.889)
Platelets, Month 8, n=84 Number Analyzed 84 participants
3.74  (24.695)
Platelets, Month 12, n=84 Number Analyzed 84 participants
1.14  (32.005)
38.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm
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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Basophils, Month 3 -0.008  (0.01464)
Basophils, Month 6 -0.010  (0.02309)
Basophils, Month 9 -0.005  (0.01512)
Basophils, Month 12 -0.010  (0.01732)
Eosinophils, Month 3 -0.072  (0.16307)
Eosinophils, Month 6 -0.057  (0.11236)
Eosinophils, Month 9 -0.051  (0.10040)
Eosinophils, Month 12 -0.030  (0.17127)
Leukocytes, Month 3 0.014  (0.7669)
Leukocytes, Month 6 -0.386  (0.8355)
Leukocytes, Month 9 0.014  (1.3508)
Leukocytes, Month 12 -0.057  (0.9343)
Lymphocytes, Month 3 0.053  (0.43811)
Lymphocytes, Month 6 -0.019  (0.35435)
Lymphocytes, Month 9 0.085  (0.59379)
Lymphocytes, Month 12 -0.001  (0.39121)
Monocytes, Month 3 0.098  (0.08877)
Monocytes, Month 6 0.020  (0.07211)
Monocytes, Month 9 -0.021  (0.06644)
Monocytes, Month 12 0.004  (0.07435)
Neutrophils, Month 3 0.097  (0.47612)
Neutrophils, Month 6 -0.295  (0.64143)
Neutrophils, Month 9 0.115  (1.20803)
Neutrophils, Month 12 -0.034  (0.80715)
Platelets, Month 3 -1.00  (18.841)
Platelets, Month 6 -12.57  (35.298)
Platelets, Month 9 -21.29  (61.372)
Platelets, Month 12 -2.86  (47.544)
39.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm
Hide Description Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. 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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Month 2, n=85 Number Analyzed 85 participants
-1.07  (1.731)
Month 4, n=82 Number Analyzed 82 participants
-2.04  (2.186)
Month 8, n=86 Number Analyzed 86 participants
-1.42  (2.527)
Month 12, n=86 Number Analyzed 86 participants
-1.28  (2.528)
40.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm
Hide Description Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. 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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Month 3 -1.00  (1.000)
Month 6 0.14  (1.574)
Month 9 0.29  (1.704)
Month 12 -0.14  (1.952)
41.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm
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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
Month 2, n=85 Number Analyzed 85 participants
-0.064  (0.2773)
Month 4, n=82 Number Analyzed 82 participants
-0.021  (0.3185)
Month 8, n=86 Number Analyzed 86 participants
-0.085  (0.3164)
Month 12, n=86 Number Analyzed 86 participants
-0.063  (0.3279)
42.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm
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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
Month 3 -0.114  (0.1464)
Month 6 -0.171  (0.1113)
Month 9 -0.171  (0.1704)
Month 12 -0.143  (0.0976)
43.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm
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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Month 2, n=85 Number Analyzed 85 participants
-0.011  (0.02762)
Month 4, n=82 Number Analyzed 82 participants
-0.012  (0.02935)
Month 8, n=86 Number Analyzed 86 participants
-0.015  (0.02809)
Month 12, n=86 Number Analyzed 86 participants
-0.011  (0.02760)
44.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm
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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Month 3 -0.015  (0.01516)
Month 6 -0.013  (0.01287)
Month 9 -0.013  (0.01332)
Month 12 -0.013  (0.01491)
45.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm
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 at Months 2, 4, 8 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Month 2, n=85 Number Analyzed 85 participants
-2.11  (8.801)
Month 4, n=82 Number Analyzed 82 participants
-1.57  (9.433)
Month 8, n=86 Number Analyzed 86 participants
-3.29  (8.542)
Month 12, n=86 Number Analyzed 86 participants
-3.19  (8.814)
46.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm
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 at Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Month 3 -3.57  (6.554)
Month 6 -4.29  (2.928)
Month 9 -4.86  (3.891)
Month 12 -4.57  (5.062)
47.Secondary Outcome
Title Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio
Hide Description Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.
Time Frame At Day 1
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Mean (Standard Deviation)
Unit of Measure: Ratio
Urine albumin/creatinine ratio, n=68, 5 Number Analyzed 68 participants 5 participants
0.7  (0.980) 0.4  (0.122)
Urine protein/creatinine ratio, n=73, 5 Number Analyzed 73 participants 5 participants
7.6  (4.528) 9.1  (7.237)
48.Secondary Outcome
Title Absolute Values of Urine Creatinine
Hide Description Urine samples were collected for the analysis of urine creatinine.
Time Frame At Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
14875.6  (9267.95) 12112.9  (7186.16)
49.Secondary Outcome
Title Absolute Values of Urine Phosphate
Hide Description Urine samples were collected for the analysis of urine phosphate.
Time Frame At Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
18.2  (15.306) 14.7  (6.917)
50.Secondary Outcome
Title Absolute Values of Urine Specific Gravity
Hide Description Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Time Frame At Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at specified time points has been presented.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 89 7
Mean (Standard Deviation)
Unit of Measure: Ratio
1.0  (0.007) 1.0  (0.007)
51.Secondary Outcome
Title Absolute Values of Urine Potential of Hydrogen (pH)
Hide Description Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time Frame At Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at specified time points has been presented.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 89 7
Mean (Standard Deviation)
Unit of Measure: pH
6.1  (0.739) 6.5  (0.345)
52.Secondary Outcome
Title Number of Participants With Treatment Emergent Genotypic Resistance
Hide Description Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.
Time Frame Up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants reporting confirmed virologic failure were analyzed.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
53.Secondary Outcome
Title Number of Participants With Treatment Emergent Phenotypic Resistance
Hide Description Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.
Time Frame Up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants reporting confirmed virologic failure were analyzed.
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
54.Secondary Outcome
Title Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV)
Hide Description HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted impact score was calculated for 26 individual domain items by multiplying impact score (-3[maximum negative impact] to +1[maximum positive impact] by the corresponding importance score (3 [very important] to 0[not all important]). Average Weighted impact (AWI) score was calculated by summing individual weighted impact scores and dividing by the number of domain items. The ranges of weighted impact score and average impact score were from -9(maximum negative impact) to +3(maximum positive impact); higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value).
Time Frame Baseline (Day 1) and at Months 6 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Overview Item 1, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.1  (0.65) 0.4  (0.53)
Overview Item 1, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.0  (0.75) -0.1  (0.38)
Overview Item 2, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.0  (1.11) 0.3  (1.25)
Overview Item 2, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.2  (1.05) -0.6  (1.13)
Leisure, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.1  (2.20) 0.9  (1.46)
Leisure, Month 12, n=87, 7 Number Analyzed 87 participants 7 participants
0.2  (2.02) -1.6  (3.74)
Work, Month 6, n=86, 7 Number Analyzed 86 participants 7 participants
-0.3  (2.07) -0.9  (4.14)
Work, Month 12, n=84, 7 Number Analyzed 84 participants 7 participants
-0.1  (2.48) -0.7  (2.75)
Holiday, Month 6, n=84, 7 Number Analyzed 84 participants 7 participants
-0.5  (2.24) -0.3  (3.55)
Holiday, Month 12, n=84, 5 Number Analyzed 84 participants 5 participants
-0.1  (2.76) -2.0  (2.83)
Getting out and about, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.0  (1.83) -1.1  (3.76)
Getting out and about, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.2  (2.01) -1.9  (2.48)
Long journey, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.3  (2.24) -0.4  (2.70)
Long journey, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.4  (2.45) -2.3  (2.93)
Do Physically, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.2  (2.09) -0.7  (2.36)
Do Physically, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.3  (2.39) -1.7  (2.63)
Family, Month 6, n=83, 7 Number Analyzed 83 participants 7 participants
-0.1  (1.38) -0.9  (2.27)
Family, Month 12, n=82, 6 Number Analyzed 82 participants 6 participants
-0.3  (2.30) -1.5  (2.51)
Friends, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.7  (1.93) -1.1  (2.85)
Friends, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.3  (2.57) -2.0  (2.38)
Go on dates, Month 6, n=62, 2 Number Analyzed 62 participants 2 participants
-0.4  (2.04) -3.5  (3.54)
Go on dates, Month 12, n=60, 2 Number Analyzed 60 participants 2 participants
-0.2  (3.11) -3.5  (3.54)
Close relationships, Month 6, n=71, 6 Number Analyzed 71 participants 6 participants
0.4  (3.10) -0.5  (2.95)
Close relationships, Month 12, n=68, 6 Number Analyzed 68 participants 6 participants
0.2  (3.13) -0.5  (2.95)
Sex life, Month 6, n=80, 6 Number Analyzed 80 participants 6 participants
0.2  (2.74) -1.3  (2.80)
Sex life, Month 12, n=80, 5 Number Analyzed 80 participants 5 participants
-0.2  (2.62) -1.0  (3.00)
Physical appearance, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.3  (1.78) -1.1  (2.85)
Physical appearance, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.2  (2.28) -1.4  (2.23)
Self-confidence, Month 6, n=88, 7 Number Analyzed 88 participants 7 participants
0.0  (2.35) -1.7  (2.43)
Self-confidence, Month 12, n=86, 7 Number Analyzed 86 participants 7 participants
0.2  (2.83) -2.9  (3.48)
Motivation, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.3  (2.04) -0.6  (2.51)
Motivation, Month 12, n=86, 7 Number Analyzed 86 participants 7 participants
-0.3  (2.85) -2.1  (2.85)
Stigma, Month 6, n=40, 0 Number Analyzed 40 participants 0 participants
-1.1  (2.38)
Stigma, Month 12, n=38, 1 Number Analyzed 38 participants 1 participants
0.0  (3.03) -2.0 [1]   (NA)
Conceal, Month 6, n=55, 5 Number Analyzed 55 participants 5 participants
-0.6  (2.91) -1.6  (3.51)
Conceal, Month 12, n=55, 5 Number Analyzed 55 participants 5 participants
0.3  (3.04) -0.4  (4.10)
Feelings About the Future, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.0  (2.89) 1.0  (2.24)
Feelings About the Future, Month 12, n=87, 7 Number Analyzed 87 participants 7 participants
0.3  (3.02) -0.9  (2.85)
Financial Situation, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.1  (2.76) 1.1  (1.46)
Financial Situation, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.1  (2.59) -0.6  (4.61)
Depend on Others, Month 6, n=37, 4 Number Analyzed 37 participants 4 participants
-0.4  (3.11) 0.0  (0.00)
Depend on Others, Month 12, n=35, 6 Number Analyzed 35 participants 6 participants
-0.2  (2.73) -1.2  (3.25)
Others Fuss or Worry, Month 6, n=42, 5 Number Analyzed 42 participants 5 participants
0.0  (3.00) -1.6  (3.36)
Others Fuss or Worry, Month 12, n=35, 6 Number Analyzed 35 participants 6 participants
0.1  (3.21) -0.3  (3.50)
Freedom to Eat, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.0  (1.98) -1.3  (3.40)
Freedom to Eat, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.1  (2.62) -1.1  (2.48)
Freedom to Drink, Month 6, n=88, 7 Number Analyzed 88 participants 7 participants
-0.2  (1.81) -0.7  (4.42)
Freedom to Drink, Month 12, n=87, 7 Number Analyzed 87 participants 7 participants
-0.1  (2.47) -1.7  (3.40)
Spiritual/Religious Life, Month 6, n=46, 6 Number Analyzed 46 participants 6 participants
-0.1  (2.46) -0.5  (1.22)
Spiritual/Religious Life, Month 12, n=45, 6 Number Analyzed 45 participants 6 participants
-0.1  (1.14) -1.0  (2.45)
Feelings About the Past, Month 6, n=88, 7 Number Analyzed 88 participants 7 participants
-0.3  (2.69) 0.7  (2.21)
Feelings About the Past, Month 12, n=87, 7 Number Analyzed 87 participants 7 participants
0.0  (2.74) -1.3  (2.21)
Having Children or More Children, Month 6, n=30, 4 Number Analyzed 30 participants 4 participants
0.3  (1.86) 1.3  (4.27)
Having Children or More Children, Month 12,n=35, 4 Number Analyzed 35 participants 4 participants
-0.3  (2.82) -1.5  (3.00)
Sleep, Month 6, n=87, 7 Number Analyzed 87 participants 7 participants
-0.2  (2.32) 0.7  (1.25)
Sleep, Month 12, n=87, 7 Number Analyzed 87 participants 7 participants
0.0  (2.56) -0.4  (2.70)
Average Weighted Impact, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.17  (1.084) -0.43  (1.792)
Average Weighted Impact, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.07  (1.690) -1.27  (1.695)
[1]
Standard deviation could not be calculated for single participant.
55.Secondary Outcome
Title Change From Baseline in Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
Hide Description HIVTSQs total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. 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 at Months 6 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.19  (6.419) 0.71  (3.773)
Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.42  (6.659) 0.14  (6.256)
56.Secondary Outcome
Title Change From Baseline in Individual Item Score of HIVTSQs
Hide Description HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Months 6 and 12
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 category titles).
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 90 7
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Item 1, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.1  (0.82) 0.0  (0.00)
Item 1, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.1  (0.75) -0.1  (0.38)
Item 2, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.1  (0.46) -0.3  (0.49)
Item 2, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.0  (0.34) -0.1  (0.38)
Item 3, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.5  (1.41) 0.1  (0.38)
Item 3, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.5  (1.21) -0.1  (0.38)
Item 4, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.0  (0.95) 0.0  (0.00)
Item 4, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.1  (0.93) 0.1  (0.69)
Item 5, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.1  (1.00) 0.3  (0.49)
Item 5, Month 12, n=87, 7 Number Analyzed 87 participants 7 participants
0.1  (1.14) 0.1  (0.38)
Item 6, Month 6, n=88, 7 Number Analyzed 88 participants 7 participants
0.1  (1.13) 0.4  (1.62)
Item 6, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.0  (1.31) 0.3  (1.80)
Item 7, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.1  (0.74) 0.0  (0.58)
Item 7, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.0  (1.06) 0.1  (0.69)
Item 8, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.2  (0.93) 0.0  (0.58)
Item 8, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.1  (0.95) 0.0  (0.58)
Item 9, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-0.1  (0.61) 0.0  (0.00)
Item 9, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-0.2  (0.80) -0.1  (0.38)
Item 10, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.1  (0.91) 0.3  (0.76)
Item 10, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.1  (1.03) 0.1  (0.90)
Item 11, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
0.0  (1.09) -0.1  (0.38)
Item 11, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
0.1  (0.79) -0.1  (0.90)
Item 12, Month 6, n=89, 7 Number Analyzed 89 participants 7 participants
-1.3  (1.59) -0.6  (1.13)
Item 12, Month 12, n=88, 7 Number Analyzed 88 participants 7 participants
-1.1  (1.58) -0.1  (0.38)
57.Secondary Outcome
Title Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)
Hide Description HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and remain missing.
Time Frame At Month 12
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 Q2M DTG + RPV
Hide Arm/Group Description:
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed 88 7
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
28.0  (6.78) 27.7  (6.97)
58.Other Pre-specified Outcome
Title Plasma Trough Concentration (Ctrough) for CAB LA
Hide Description Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted.
Time Frame Pre-dose (Day 1) and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title CAB LA
Hide Arm/Group Description:
Participants in this arm received their first dose CAB LA (600 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (CAB LA 600 mg) occurring Q2M thereafter.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
59.Other Pre-specified Outcome
Title Ctrough for RPV LA
Hide Description Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted.
Time Frame Pre-dose (Day 1) and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title RPV LA
Hide Arm/Group Description:
Participants in this arm received their first dose RPV LA (900 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (RPV LA 900 mg) occurring Q2M thereafter.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Non-SAEs and SAEs were collected from Day 1 and up to Month 17
Adverse Event Reporting Description Non-SAEs and SAEs were collected in Safety Population.
 
Arm/Group Title CAB LA + RPV LA Q2M DTG + RPV
Hide Arm/Group Description Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA. Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
All-Cause Mortality
CAB LA + RPV LA Q2M DTG + RPV
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
CAB LA + RPV LA Q2M DTG + RPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/90 (5.56%)      0/7 (0.00%)    
Gastrointestinal disorders     
Proctitis  1  1/90 (1.11%)  1 0/7 (0.00%)  0
General disorders     
Injection site extravasation  1  1/90 (1.11%)  1 0/7 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  1/90 (1.11%)  1 0/7 (0.00%)  0
Cholelithiasis  1  1/90 (1.11%)  1 0/7 (0.00%)  0
Infections and infestations     
Anal abscess  1  1/90 (1.11%)  1 0/7 (0.00%)  0
Orchitis  1  1/90 (1.11%)  1 0/7 (0.00%)  0
Urinary tract infection bacterial  1  1/90 (1.11%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CAB LA + RPV LA Q2M DTG + RPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/90 (84.44%)      3/7 (42.86%)    
Gastrointestinal disorders     
Diarrhoea  1  9/90 (10.00%)  13 0/7 (0.00%)  0
Haemorrhoids  1  5/90 (5.56%)  5 0/7 (0.00%)  0
Nausea  1  5/90 (5.56%)  5 0/7 (0.00%)  0
Abdominal pain  1  2/90 (2.22%)  3 1/7 (14.29%)  1
General disorders     
Injection site pain  1  67/90 (74.44%)  414 0/7 (0.00%)  0
Injection site discomfort  1  10/90 (11.11%)  20 0/7 (0.00%)  0
Pyrexia  1  9/90 (10.00%)  20 0/7 (0.00%)  0
Fatigue  1  6/90 (6.67%)  16 0/7 (0.00%)  0
Injection site nodule  1  5/90 (5.56%)  6 0/7 (0.00%)  0
Injection site swelling  1  5/90 (5.56%)  11 0/7 (0.00%)  0
Hepatobiliary disorders     
Hepatic steatosis  1  0/90 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations     
Nasopharyngitis  1  10/90 (11.11%)  10 0/7 (0.00%)  0
Upper respiratory tract infection  1  10/90 (11.11%)  11 0/7 (0.00%)  0
Syphilis  1  6/90 (6.67%)  6 0/7 (0.00%)  0
Injury, poisoning and procedural complications     
Muscle strain  1  1/90 (1.11%)  1 1/7 (14.29%)  1
Nervous system disorders     
Headache  1  6/90 (6.67%)  7 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/90 (5.56%)  5 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythema  1  0/90 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03639311    
Other Study ID Numbers: 209035
First Submitted: August 10, 2018
First Posted: August 21, 2018
Results First Submitted: November 20, 2020
Results First Posted: January 15, 2021
Last Update Posted: March 22, 2021