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Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)

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ClinicalTrials.gov Identifier: NCT02422797
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Results First Posted : October 24, 2017
Last Update Posted : April 17, 2020
Sponsor:
Collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: DTG 50 mg
Drug: RPV 25 mg
Drug: CAR
Enrollment 518
Recruitment Details This study was a 148-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study to assess the antiviral activity and safety of a two-drug regimen of dolutegravir (DTG) + rilpivirine (RPV) compared with current antiretroviral regimen (CAR). The study was conducted at 60 centers in 11 countries.
Pre-assignment Details Total 670 participants were screened (152 failed), 518 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included a Screening phase, an early switch phase, a late switch phase, and a continuation phase. The results presented are based on the interim analysis of the Late Switch Phase (Week 148).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Period Title: Early Switch Phase (Up to Week 52)
Started 261 255
Completed 245 239
Not Completed 16 16
Reason Not Completed
Adverse Event             11             1
Physician Decision             0             1
Lack of Efficacy             1             2
Lost to Follow-up             1             1
Protocol Violation             0             3
Reached stopping criteria             1             1
Withdrawal by Subject             2             7
Period Title: Late Switch Phase (Week 52 to Week 148)
Started 245 239
Completed 222 221
Not Completed 23 18
Reason Not Completed
Physician Decision             0             1
Adverse Event             10             6
Lack of Efficacy             5             3
Lost to Follow-up             2             2
Withdrawal by Subject             2             6
Reached stopping criteria             1             0
Protocol Violation             3             0
Arm/Group Title DTG + RPV Current Antiretroviral Regimen Total
Hide Arm/Group Description Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148. Total of all reporting groups
Overall Number of Baseline Participants 261 255 516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants 255 participants 516 participants
43.3  (11.34) 43.2  (9.64) 43.3  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 255 participants 516 participants
Female
62
  23.8%
57
  22.4%
119
  23.1%
Male
199
  76.2%
198
  77.6%
397
  76.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 255 participants 516 participants
American Indian or Alaska Native
11
   4.2%
7
   2.7%
18
   3.5%
Central/South Asian Heritage
0
   0.0%
1
   0.4%
1
   0.2%
Japanese/East Asian (EA) Heritage (H.)/South EA H.
13
   5.0%
15
   5.9%
28
   5.4%
Black/African American
13
   5.0%
19
   7.5%
32
   6.2%
Native Hawaiian or other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
White
223
  85.4%
212
  83.1%
435
  84.3%
African American/ African H. and White
0
   0.0%
1
   0.4%
1
   0.2%
1.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
Hide Description Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Number
Unit of Measure: Percentage of participants
94 94
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-3.9 to 4.2
Estimation Comments Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INSTI).
2.Secondary Outcome
Title Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Hide Description Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1), Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Cells per millimeter cube (mm^3)
Week 24, n=251, 250 Number Analyzed 251 participants 250 participants
42.0  (172.29) 42.4  (164.85)
Week 48, n=245, 241 Number Analyzed 245 participants 241 participants
28.0  (169.35) 18.4  (159.34)
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
Hide Description Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Number
Unit of Measure: Percentage of participants
97 98
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-4.0 to 1.8
Estimation Comments Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.
4.Secondary Outcome
Title Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with >5% incidence for either treatment. This summary presents results as reported after all participants completed the Early Switch Phase.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study drug.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Count of Participants
Unit of Measure: Participants
Common non-serious AE
61
  23.4%
59
  23.1%
Any SAE
18
   6.9%
9
   3.5%
Maximum toxicity Grade 1 AE
119
  45.6%
122
  47.8%
Maximum toxicity Grade 2 AE
59
  22.6%
47
  18.4%
Maximum toxicity Grade 3 AE
16
   6.1%
4
   1.6%
Maximum toxicity Grade 4 AE
1
   0.4%
1
   0.4%
AELD
12
   4.6%
1
   0.4%
5.Secondary Outcome
Title Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Hide Description Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
92
  35.2%
80
  31.4%
Grade 2
72
  27.6%
79
  31.0%
Grade 3
11
   4.2%
16
   6.3%
Grade 4
1
   0.4%
10
   3.9%
6.Secondary Outcome
Title Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Hide Description Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
11
   4.2%
11
   4.3%
Grade 2
2
   0.8%
2
   0.8%
Grade 3
3
   1.1%
0
   0.0%
Grade 4
1
   0.4%
0
   0.0%
7.Secondary Outcome
Title Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 246 239
Mean (Standard Deviation)
Unit of Measure: mg/Liter (L)
0.10  (5.383) 0.80  (8.527)
8.Secondary Outcome
Title Mean Change From Baseline in Cystatin C at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 246 237
Mean (Standard Deviation)
Unit of Measure: mg/L
-0.02  (0.110) -0.01  (0.108)
9.Secondary Outcome
Title Mean Change From Baseline in D-Dimer at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 239 228
Mean (Standard Deviation)
Unit of Measure: Nanomole/L fibrinogen equivalent units
0.01  (1.629) -0.13  (2.932)
10.Secondary Outcome
Title Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Nanogram/milliliter
FABP, n=245, 236 Number Analyzed 245 participants 236 participants
-1.50  (1.278) -0.99  (1.441)
Soluble CD14, n=245, 237 Number Analyzed 245 participants 237 participants
456.69  (731.833) 802.26  (878.304)
11.Secondary Outcome
Title Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Microgram/Liter
Soluble CD163, n=245, 236 Number Analyzed 245 participants 236 participants
65.38  (180.869) 53.94  (215.621)
Oxidized LDL, n=245, 237 Number Analyzed 245 participants 237 participants
60.87  (504.345) 13.92  (575.305)
12.Secondary Outcome
Title Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: mg/deciliter (dL)
RBP, n=245, 237 Number Analyzed 245 participants 237 participants
-0.13  (0.825) 0.00  (0.872)
Serum creatinine, n=245, 241 Number Analyzed 245 participants 241 participants
0.100  (0.1053) -0.003  (0.0847)
Glucose, n=242, 235 Number Analyzed 242 participants 235 participants
0.187  (19.5808) 3.220  (10.0987)
13.Secondary Outcome
Title Mean Change From Baseline in Urine Phosphate at Week 48
Hide Description Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 235 229
Mean (Standard Deviation)
Unit of Measure: Millimoles (mmol)/L
1.335  (16.7211) -0.798  (15.3771)
14.Secondary Outcome
Title Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Nanomoles (nmol)/L
B2M, blood, n=245, 238 Number Analyzed 245 participants 238 participants
-16.8800  (34.89330) -4.7501  (43.04355)
25 hydroxy-vitamin D, blood, n=243, 239 Number Analyzed 243 participants 239 participants
-13.9  (25.30) -9.2  (19.55)
Urine B2M, n=72, 78 Number Analyzed 72 participants 78 participants
-173.2820  (1311.24142) 62.3209  (391.32049)
Urine RBP, n=232, 224 Number Analyzed 232 participants 224 participants
-6.8123  (24.09650) -0.0631  (11.99886)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P value to assess difference between treatment groups (25 hydroxy-vitamin D - INSTI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.861
Confidence Interval (2-Sided) 95%
0.767 to 0.967
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.012
Confidence Interval (2-Sided) 95%
0.943 to 1.085
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.877
Confidence Interval (2-Sided) 95%
0.787 to 0.977
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
15.Secondary Outcome
Title Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Hide Description Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Grams (g)/mol
Urine albumin/creatinine ratio, n=178, 181 Number Analyzed 178 participants 181 participants
-0.78  (5.116) -0.64  (9.538)
Urine protein/creatinine ratio, n=192, 193 Number Analyzed 192 participants 193 participants
-2.73  (12.683) 1.23  (5.088)
16.Secondary Outcome
Title Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Microgram (ug)/L
Bone-specific alkaline phosphatase, n=246, 236 Number Analyzed 246 participants 236 participants
-3.18  (5.678) 0.92  (4.634)
Procollagen type 1 N-propeptide, n=245, 237 Number Analyzed 245 participants 237 participants
-5.8  (20.00) 0.3  (19.28)
Osteocalcin, n=245, 235 Number Analyzed 245 participants 235 participants
-5.11  (7.334) -1.14  (6.017)
Type I Collagen C-Telopeptides, n=243, 238 Number Analyzed 243 participants 238 participants
-0.15  (0.313) -0.09  (0.344)
sVCAM, n=245, 237 Number Analyzed 245 participants 237 participants
-2.63  (571.182) 37.42  (617.486)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.728
Confidence Interval (2-Sided) 95%
0.686 to 0.773
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INSTI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.865
Confidence Interval (2-Sided) 95%
0.785 to 0.954
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.788
Confidence Interval (2-Sided) 95%
0.719 to 0.864
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P value to assess difference between treatment groups (procollagen type 1-N-propeptide)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.867
Confidence Interval (2-Sided) 95%
0.823 to 0.914
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P-value for interaction between treatment group and Baseline third agent (osteocalcin)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P value to assess difference between treatment groups (osteocalcin - NNRTI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.853
Confidence Interval (2-Sided) 95%
0.799 to 0.910
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments P value to assess difference between treatment groups (osteocalcin - INSTI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.886
Confidence Interval (2-Sided) 95%
0.796 to 0.987
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P value to assess difference between treatment groups (osteocalcin - PI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.743
Confidence Interval (2-Sided) 95%
0.672 to 0.822
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.782
Comments P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.818
Confidence Interval (2-Sided) 95%
0.751 to 0.891
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.
17.Secondary Outcome
Title Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 245 237
Mean (Standard Deviation)
Unit of Measure: Nanograms (ng)/L
-0.08  (2.373) -0.07  (2.761)
18.Secondary Outcome
Title Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
Hide Description Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 237 224
Mean (Standard Deviation)
Unit of Measure: HOMA-IR Score
0.50  (4.780) 0.80  (3.938)
19.Secondary Outcome
Title Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Hide Description Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1), Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Millimoles (mmol)/L
Total cholesterol, Week 24, n=237, 229 Number Analyzed 237 participants 229 participants
-0.015  (0.7539) 0.020  (0.5777)
Total cholesterol, Week 48, n=237, 230 Number Analyzed 237 participants 230 participants
-0.079  (0.7926) -0.038  (0.6148)
LDL cholesterol calculation, Week 24, n=231, 221 Number Analyzed 231 participants 221 participants
0.085  (0.5940) 0.055  (0.5232)
LDL cholesterol calculation, Week 48, n=229, 220 Number Analyzed 229 participants 220 participants
-0.049  (0.6276) -0.076  (0.5280)
HDL cholesterol direct, Week 24, n=237, 229 Number Analyzed 237 participants 229 participants
-0.024  (0.2365) -0.051  (0.2258)
HDL cholesterol direct, Week 48, n=237, 230 Number Analyzed 237 participants 230 participants
0.051  (0.2386) 0.049  (0.2489)
Triglycerides, Week 24, n=237, 229 Number Analyzed 237 participants 229 participants
-0.184  (1.0102) 0.040  (0.9164)
Triglycerides, Week 48, n=237, 230 Number Analyzed 237 participants 230 participants
-0.169  (1.0062) -0.021  (1.0156)
20.Secondary Outcome
Title Number of Participants With Genotypic Resistance-Early Switch Phase
Hide Description Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine [RPV], Dolutegravir [DTG]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented. CVW resistance Population comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
CVW resistance Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
INSTI, DTG, Susceptible
1
 100.0%
INSTI, DTG, Potential low-level resistance
0
   0.0%
INSTI, DTG, Low-level resistance
0
   0.0%
INSTI, DTG, Intermediate resistance
0
   0.0%
INSTI, DTG, High-level resistance
0
   0.0%
NNRTI, RPV, Susceptible
0
   0.0%
NNRTI, RPV, Potential low-level resistance
0
   0.0%
NNRTI, RPV, Low-level resistance
0
   0.0%
NNRTI, RPV, Intermediate resistance
1
 100.0%
NNRTI, RPV, High-level resistance
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Arm Through Early and Late Switch Phase
Hide Description Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir [EVG], Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine [NVP], RPV, Lamivudine [3TC], Abacavir [ABC], FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/r [ATV/r], DRV/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]) in participants Meeting Confirmed Virologic Withdrawal Criteria has been presented.
Time Frame Up to Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
CVW resistance Population
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
INI, DTG, Susceptible
2
 100.0%
INI, DTG, Potential low-level resistance
0
   0.0%
INI, DTG, Low-level resistance
0
   0.0%
INI, DTG, Intermediate resistance
0
   0.0%
INI, DTG, High-level resistance
0
   0.0%
INI, EVG, Susceptible
2
 100.0%
INI, EVG, Potential low-level resistance
0
   0.0%
INI, EVG, Low-level resistance
0
   0.0%
INI, EVG, Intermediate resistance
0
   0.0%
INI, EVG, High-level resistance
0
   0.0%
INI, RAL, Susceptible
2
 100.0%
INI, RAL, Potential low-level resistance
0
   0.0%
INI, RAL, Low-level resistance
0
   0.0%
INI, RAL, Intermediate resistance
0
   0.0%
INI, RAL, High-level resistance
0
   0.0%
NNRTI, DLV, Susceptible
2
 100.0%
NNRTI, DLV, Potential low-level resistance
0
   0.0%
NNRTI, DLV, Low-level resistance
0
   0.0%
NNRTI, DLV, Intermediate resistance
0
   0.0%
NNRTI, DLV, High-level resistance
0
   0.0%
NNRTI, EFV, Susceptible
0
   0.0%
NNRTI, EFV, Potential low-level resistance
0
   0.0%
NNRTI, EFV, Low-level resistance
1
  50.0%
NNRTI, EFV, Intermediate resistance
0
   0.0%
NNRTI, EFV, High-level resistance
1
  50.0%
NNRTI, ETR, Susceptible
0
   0.0%
NNRTI, ETR, Potential low-level resistance
0
   0.0%
NNRTI, ETR, Low-level resistance
1
  50.0%
NNRTI, ETR, Intermediate resistance
0
   0.0%
NNRTI, ETR, High-level resistance
1
  50.0%
NNRTI, NVP, Susceptible
0
   0.0%
NNRTI, NVP, Potential low-level resistance
0
   0.0%
NNRTI, NVP, Low-level resistance
0
   0.0%
NNRTI, NVP, Intermediate resistance
1
  50.0%
NNRTI, NVP, High-level resistance
1
  50.0%
NNRTI, RPV, Susceptible
0
   0.0%
NNRTI, RPV, Potential low-level resistance
0
   0.0%
NNRTI, RPV, Low-level resistance
0
   0.0%
NNRTI, RPV, Intermediate resistance
1
  50.0%
NNRTI, RPV, High-level resistance
1
  50.0%
NRTI, 3TC, Susceptible
2
 100.0%
NRTI, 3TC, Potential low-level resistance
0
   0.0%
NRTI, 3TC, Low-level resistance
0
   0.0%
NRTI, 3TC, Intermediate resistance
0
   0.0%
NRTI, 3TC, High-level resistance
0
   0.0%
NRTI, ABC, Susceptible
2
 100.0%
NRTI, ABC, Potential low-level resistance
0
   0.0%
NRTI, ABC, Low-level resistance
0
   0.0%
NRTI, ABC, Intermediate resistance
0
   0.0%
NRTI, ABC, High-level resistance
0
   0.0%
NRTI, FTC, Susceptible
2
 100.0%
NRTI, FTC, Potential low-level resistance
0
   0.0%
NRTI, FTC, Low-level resistance
0
   0.0%
NRTI, FTC, Intermediate resistance
0
   0.0%
NRTI, FTC, High-level resistance
0
   0.0%
NRTI, TDF, Susceptible
2
 100.0%
NRTI, TDF, Potential low-level resistance
0
   0.0%
NRTI, TDF, Low-level resistance
0
   0.0%
NRTI, TDF, Intermediate resistance
0
   0.0%
NRTI, TDF, High-level resistance
0
   0.0%
NRTI, ZDV, Susceptible
2
 100.0%
NRTI, ZDV, Potential low-level resistance
0
   0.0%
NRTI, ZDV, Low-level resistance
0
   0.0%
NRTI, ZDV, Intermediate resistance
0
   0.0%
NRTI, ZDV, High-level resistance
0
   0.0%
NRTI, d4T, Susceptible
2
 100.0%
NRTI, d4T, Potential low-level resistance
0
   0.0%
NRTI, d4T, Low-level resistance
0
   0.0%
NRTI, d4T, Intermediate resistance
0
   0.0%
NRTI, d4T, High-level resistance
0
   0.0%
NRTI, ddI, Susceptible
2
 100.0%
NRTI, ddI, Potential low-level resistance
0
   0.0%
NRTI, ddI, Low-level resistance
0
   0.0%
NRTI, ddI, Intermediate resistance
0
   0.0%
NRTI, ddI, High-level resistance
0
   0.0%
PI, ATV/r, Susceptible
2
 100.0%
PI, ATV/r, Potential low-level resistance
0
   0.0%
PI, ATV/r, Low-level resistance
0
   0.0%
PI, ATV/r, Intermediate resistance
0
   0.0%
PI, ATV/r, High-level resistance
0
   0.0%
PI, DRV/r, Susceptible
2
 100.0%
PI, DRV/r, Potential low-level resistance
0
   0.0%
PI, DRV/r, Low-level resistance
0
   0.0%
PI, DRV/r, Intermediate resistance
0
   0.0%
PI, DRV/r, High-level resistance
0
   0.0%
PI, FPV/r, Susceptible
2
 100.0%
PI, FPV/r, Potential low-level resistance
0
   0.0%
PI, FPV/r, Low-level resistance
0
   0.0%
PI, FPV/r, Intermediate resistance
0
   0.0%
PI, FPV/r, High-level resistance
0
   0.0%
PI, IDV/r, Susceptible
2
 100.0%
PI, IDV/r, Potential low-level resistance
0
   0.0%
PI, IDV/r, Low-level resistance
0
   0.0%
PI, IDV/r, Intermediate resistance
0
   0.0%
PI, IDV/r, High-level resistance
0
   0.0%
PI, LPV/r, Susceptible
2
 100.0%
PI, LPV/r, Potential low-level resistance
0
   0.0%
PI, LPV/r, Low-level resistance
0
   0.0%
PI, LPV/r, Intermediate resistance
0
   0.0%
PI, LPV/r, High-level resistance
0
   0.0%
PI, NFV, Susceptible
2
 100.0%
PI, NFV, Potential low-level resistance
0
   0.0%
PI, NFV, Low-level resistance
0
   0.0%
PI, NFV, Intermediate resistance
0
   0.0%
PI, NFV, High-level resistance
0
   0.0%
PI, RTV, Susceptible
2
 100.0%
PI, RTV, Potential low-level resistance
0
   0.0%
PI, RTV, Low-level resistance
0
   0.0%
PI, RTV, Intermediate resistance
0
   0.0%
PI, RTV, High-level resistance
0
   0.0%
PI, SQV/r, Susceptible
2
 100.0%
PI, SQV/r, Potential low-level resistance
0
   0.0%
PI, SQV/r, Low-level resistance
0
   0.0%
PI, SQV/r, Intermediate resistance
0
   0.0%
PI, SQV/r, High-level resistance
0
   0.0%
PI, TPV/r, Susceptible
2
 100.0%
PI, TPV/r, Potential low-level resistance
0
   0.0%
PI, TPV/r, Low-level resistance
0
   0.0%
PI, TPV/r, Intermediate resistance
0
   0.0%
PI, TPV/r, High-level resistance
0
   0.0%
22.Secondary Outcome
Title Number of Participants With Genotypic Resistance-CAR Late Switch Arm Through Late Switch Phase
Hide Description Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented. Late Switch (LS) CVW resistance Population comprised of all participants in the LS ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion is met.
Time Frame Post-LS Baseline (Week 52) up to Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS CVW resistance Population
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
INI, DTG, Susceptible
1
 100.0%
INI, DTG, Potential low-level resistance
0
   0.0%
INI, DTG, Low-level resistance
0
   0.0%
INI, DTG, Intermediate resistance
0
   0.0%
INI, DTG, High-level resistance
0
   0.0%
INI, EVG, Susceptible
1
 100.0%
INI, EVG, Potential low-level resistance
0
   0.0%
INI, EVG, Low-level resistance
0
   0.0%
INI, EVG, Intermediate resistance
0
   0.0%
INI, EVG, High-level resistance
0
   0.0%
INI, RAL, Susceptible
1
 100.0%
INI, RAL, Potential low-level resistance
0
   0.0%
INI, RAL, Low-level resistance
0
   0.0%
INI, RAL, Intermediate resistance
0
   0.0%
INI, RAL, High-level resistance
0
   0.0%
NNRTI, DLV, Susceptible
1
 100.0%
NNRTI, DLV, Potential low-level resistance
0
   0.0%
NNRTI, DLV, Low-level resistance
0
   0.0%
NNRTI, DLV, Intermediate resistance
0
   0.0%
NNRTI, DLV, High-level resistance
0
   0.0%
NNRTI, EFV, Susceptible
0
   0.0%
NNRTI, EFV, Potential low-level resistance
0
   0.0%
NNRTI, EFV, Low-level resistance
0
   0.0%
NNRTI, EFV, Intermediate resistance
0
   0.0%
NNRTI, EFV, High-level resistance
1
 100.0%
NNRTI, ETR, Susceptible
0
   0.0%
NNRTI, ETR, Potential low-level resistance
0
   0.0%
NNRTI, ETR, Low-level resistance
0
   0.0%
NNRTI, ETR, Intermediate resistance
1
 100.0%
NNRTI, ETR, High-level resistance
0
   0.0%
NNRTI, NVP, Susceptible
0
   0.0%
NNRTI, NVP, Potential low-level resistance
0
   0.0%
NNRTI, NVP, Low-level resistance
0
   0.0%
NNRTI, NVP, Intermediate resistance
0
   0.0%
NNRTI, NVP, High-level resistance
1
 100.0%
NNRTI, RPV, Susceptible
0
   0.0%
NNRTI, RPV, Potential low-level resistance
0
   0.0%
NNRTI, RPV, Low-level resistance
0
   0.0%
NNRTI, RPV, Intermediate resistance
0
   0.0%
NNRTI, RPV, High-level resistance
1
 100.0%
NRTI, 3TC, Susceptible
1
 100.0%
NRTI, 3TC, Potential low-level resistance
0
   0.0%
NRTI, 3TC, Low-level resistance
0
   0.0%
NRTI, 3TC, Intermediate resistance
0
   0.0%
NRTI, 3TC, High-level resistance
0
   0.0%
NRTI, ABC, Susceptible
1
 100.0%
NRTI, ABC, Potential low-level resistance
0
   0.0%
NRTI, ABC, Low-level resistance
0
   0.0%
NRTI, ABC, Intermediate resistance
0
   0.0%
NRTI, ABC, High-level resistance
0
   0.0%
NRTI, FTC, Susceptible
1
 100.0%
NRTI, FTC, Potential low-level resistance
0
   0.0%
NRTI, FTC, Low-level resistance
0
   0.0%
NRTI, FTC, Intermediate resistance
0
   0.0%
NRTI, FTC, High-level resistance
0
   0.0%
NRTI, TDF, Susceptible
1
 100.0%
NRTI, TDF, Potential low-level resistance
0
   0.0%
NRTI, TDF, Low-level resistance
0
   0.0%
NRTI, TDF, Intermediate resistance
0
   0.0%
NRTI, TDF, High-level resistance
0
   0.0%
NRTI, ZDV, Susceptible
1
 100.0%
NRTI, ZDV, Potential low-level resistance
0
   0.0%
NRTI, ZDV, Low-level resistance
0
   0.0%
NRTI, ZDV, Intermediate resistance
0
   0.0%
NRTI, ZDV, High-level resistance
0
   0.0%
NRTI, d4T, Susceptible
1
 100.0%
NRTI, d4T, Potential low-level resistance
0
   0.0%
NRTI, d4T, Low-level resistance
0
   0.0%
NRTI, d4T, Intermediate resistance
0
   0.0%
NRTI, d4T, High-level resistance
0
   0.0%
NRTI, ddI, Susceptible
1
 100.0%
NRTI, ddI, Potential low-level resistance
0
   0.0%
NRTI, ddI, Low-level resistance
0
   0.0%
NRTI, ddI, Intermediate resistance
0
   0.0%
NRTI, ddI, High-level resistance
0
   0.0%
PI, ATV/r, Susceptible
1
 100.0%
PI, ATV/r, Potential low-level resistance
0
   0.0%
PI, ATV/r, Low-level resistance
0
   0.0%
PI, ATV/r, Intermediate resistance
0
   0.0%
PI, ATV/r, High-level resistance
0
   0.0%
PI, DRV/r, Susceptible
1
 100.0%
PI, DRV/r, Potential low-level resistance
0
   0.0%
PI, DRV/r, Low-level resistance
0
   0.0%
PI, DRV/r, Intermediate resistance
0
   0.0%
PI, DRV/r, High-level resistance
0
   0.0%
PI, FPV/r, Susceptible
1
 100.0%
PI, FPV/r, Potential low-level resistance
0
   0.0%
PI, FPV/r, Low-level resistance
0
   0.0%
PI, FPV/r, Intermediate resistance
0
   0.0%
PI, FPV/r, High-level resistance
0
   0.0%
PI, IDV/r, Susceptible
1
 100.0%
PI, IDV/r, Potential low-level resistance
0
   0.0%
PI, IDV/r, Low-level resistance
0
   0.0%
PI, IDV/r, Intermediate resistance
0
   0.0%
PI, IDV/r, High-level resistance
0
   0.0%
PI, LPV/r, Susceptible
1
 100.0%
PI, LPV/r, Potential low-level resistance
0
   0.0%
PI, LPV/r, Low-level resistance
0
   0.0%
PI, LPV/r, Intermediate resistance
0
   0.0%
PI, LPV/r, High-level resistance
0
   0.0%
PI, NFV, Susceptible
1
 100.0%
PI, NFV, Potential low-level resistance
0
   0.0%
PI, NFV, Low-level resistance
0
   0.0%
PI, NFV, Intermediate resistance
0
   0.0%
PI, NFV, High-level resistance
0
   0.0%
PI, RTV, Susceptible
1
 100.0%
PI, RTV, Potential low-level resistance
0
   0.0%
PI, RTV, Low-level resistance
0
   0.0%
PI, RTV, Intermediate resistance
0
   0.0%
PI, RTV, High-level resistance
0
   0.0%
PI, SQV/r, Susceptible
1
 100.0%
PI, SQV/r, Potential low-level resistance
0
   0.0%
PI, SQV/r, Low-level resistance
0
   0.0%
PI, SQV/r, Intermediate resistance
0
   0.0%
PI, SQV/r, High-level resistance
0
   0.0%
PI, TPV/r, Susceptible
1
 100.0%
PI, TPV/r, Potential low-level resistance
0
   0.0%
PI, TPV/r, Low-level resistance
0
   0.0%
PI, TPV/r, Intermediate resistance
0
   0.0%
PI, TPV/r, High-level resistance
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Phenotypic Resistance-Early Switch Phase
Hide Description Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
CVW resistance Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
NNRTI, RPV, Resistant
0
   0.0%
NNRTI, RPV, Sensitive
1
 100.0%
NNRTI, ETR, Resistant
0
   0.0%
NNRTI, ETR, Partially Sensitive
0
   0.0%
NNRTI, ETR, Sensitive
1
 100.0%
NNRTI, DLV, Resistant
0
   0.0%
NNRTI, DLV, Sensitive
1
 100.0%
NNRTI, EFV, Resistant
0
   0.0%
NNRTI, EFV, Sensitive
1
 100.0%
NNRTI, NVP, Resistant
0
   0.0%
NNRTI, NVP, Sensitive
1
 100.0%
NRTI, 3TC, Resistant
0
   0.0%
NRTI, 3TC, Sensitive
1
 100.0%
NRTI, ABC, Resistant
0
   0.0%
NRTI, ABC, Partially Sensitive
0
   0.0%
NRTI, ABC, Sensitive
1
 100.0%
NRTI, TDF, Resistant
0
   0.0%
NRTI, TDF, Partially Sensitive
0
   0.0%
NRTI, TDF, Sensitive
1
 100.0%
NRTI, d4T, Resistant
0
   0.0%
NRTI, d4T, Sensitive
1
 100.0%
NRTI, ddI, Resistant
0
   0.0%
NRTI, ddI, Partially Sensitive
0
   0.0%
NRTI, ddI, Sensitive
1
 100.0%
NRTI, FTC, Resistant
0
   0.0%
NRTI, FTC, Sensitive
1
 100.0%
NRTI, ZDV, Resistant
0
   0.0%
NRTI, ZDV, Sensitive
1
 100.0%
PI, ATV/r, Resistant
0
   0.0%
PI, ATV/r, Sensitive
1
 100.0%
PI, DRV/r, Resistant
0
   0.0%
PI, DRV/r, Partially Sensitive
0
   0.0%
PI, DRV/r, Sensitive
1
 100.0%
PI, FPV/r, Resistant
0
   0.0%
PI, FPV/r, Partially Sensitive
0
   0.0%
PI, FPV/r, Sensitive
1
 100.0%
PI, IDV/r, Resistant
0
   0.0%
PI, IDV/r, Sensitive
1
 100.0%
PI, LPV/r, Resistant
0
   0.0%
PI, LPV/r, Partially Sensitive
0
   0.0%
PI, LPV/r, Sensitive
1
 100.0%
PI, SQV/r, Resistant
0
   0.0%
PI, SQV/r, Partially Sensitive
0
   0.0%
PI, SQV/r, Sensitive
1
 100.0%
PI, TPV/r, Resistant
0
   0.0%
PI, TPV/r, Partially Sensitive
0
   0.0%
PI, TPV/r, Sensitive
1
 100.0%
PI, NFV, Resistant
0
   0.0%
PI, NFV, Sensitive
1
 100.0%
PI, RTV, Resistant
0
   0.0%
PI, RTV, Sensitive
1
 100.0%
24.Secondary Outcome
Title Number of Participants With Phenotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time Frame Up to Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
CVW resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
INI, DTG, Resistant, n=1 Number Analyzed 1 participants
0
   0.0%
INI, DTG, Partially Sensitive, n=1 Number Analyzed 1 participants
0
   0.0%
INI, DTG, Sensitive, n=1 Number Analyzed 1 participants
1
 100.0%
INI, EVG, Resistant, n=1 Number Analyzed 1 participants
0
   0.0%
INI, EVG, Partially sensitive, n=1 Number Analyzed 1 participants
0
   0.0%
INI, EVG, Sensitive, n=1 Number Analyzed 1 participants
1
 100.0%
INI, RAL, Resistant, n=1 Number Analyzed 1 participants
1
 100.0%
INI, RAL, Partially sensitive, n=1 Number Analyzed 1 participants
0
   0.0%
INI, RAL, Sensitive, n=1 Number Analyzed 1 participants
0
   0.0%
NNRTI, DLV, Resistant, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, DLV, Partially Sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NNRTI, DLV, Sensitive, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, EFV, Resistant, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, EFV, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NNRTI, EFV, Sensitive, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, ETR, Resistant, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, ETR, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NNRTI, ETR, Sensitive, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, NVP, Resistant, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, NVP, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NNRTI, NVP, Sensitive, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, RPV, Resistant, n=2 Number Analyzed 2 participants
1
  50.0%
NNRTI, RPV, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NNRTI, RPV, Sensitive, n=2 Number Analyzed 2 participants
1
  50.0%
NRTI, 3TC, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, 3TC, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, 3TC, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
NRTI, ABC, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, ABC, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, ABC, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
NRTI, FTC, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, FTC, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, FTC, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
NRTI, TDF, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, TDF, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, TDF, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
NRTI, ZDV, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, ZDV, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, ZDV, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
NRTI, d4T, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, d4T, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, d4T, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
NRTI, ddI, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, ddI, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
NRTI, ddI, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, ATV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, ATV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, ATV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, DRV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, DRV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, DRV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, FPV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, FPV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, FPV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, IDV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, IDV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, IDV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, LPV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, LPV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, LPV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, NFV, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, NFV, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, NFV, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, RTV, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, RTV, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, RTV, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, SQV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, SQV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, SQV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
PI, TPV/r, Resistant, n=2 Number Analyzed 2 participants
0
   0.0%
PI, TPV/r, Partially sensitive, n=2 Number Analyzed 2 participants
0
   0.0%
PI, TPV/r, Sensitive, n=2 Number Analyzed 2 participants
2
 100.0%
25.Secondary Outcome
Title Number of Participants With Phenotypic Resistance-CAR Late Switch Group Through Late Switch Phase
Hide Description Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time Frame Post-LS Baseline (Week 52) up to Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS CVW resistance Population
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
NNRTI, DLV, Resistant
1
 100.0%
NNRTI, DLV, Partially Sensitive
0
   0.0%
NNRTI, DLV, Sensitive
0
   0.0%
NNRTI, EFV, Resistant
1
 100.0%
NNRTI, EFV, Partially sensitive
0
   0.0%
NNRTI, EFV, Sensitive
0
   0.0%
NNRTI, ETR, Resistant
0
   0.0%
NNRTI, ETR, Partially sensitive
1
 100.0%
NNRTI, ETR, Sensitive
0
   0.0%
NNRTI, NVP, Resistant
1
 100.0%
NNRTI, NVP, Partially sensitive
0
   0.0%
NNRTI, NVP, Sensitive
0
   0.0%
NNRTI, RPV, Resistant
1
 100.0%
NNRTI, RPV, Partially sensitive
0
   0.0%
NNRTI, RPV, Sensitive
0
   0.0%
NRTI, 3TC, Resistant
0
   0.0%
NRTI, 3TC, Partially sensitive
0
   0.0%
NRTI, 3TC, Sensitive
1
 100.0%
NRTI, ABC, Resistant
0
   0.0%
NRTI, ABC, Partially sensitive
0
   0.0%
NRTI, ABC, Sensitive
1
 100.0%
NRTI, FTC, Resistant
0
   0.0%
NRTI, FTC, Partially sensitive
0
   0.0%
NRTI, FTC, Sensitive
1
 100.0%
NRTI, TDF, Resistant
0
   0.0%
NRTI, TDF, Partially sensitive
0
   0.0%
NRTI, TDF, Sensitive
1
 100.0%
NRTI, ZDV, Resistant
0
   0.0%
NRTI, ZDV, Partially sensitive
0
   0.0%
NRTI, ZDV, Sensitive
1
 100.0%
NRTI, d4T, Resistant
0
   0.0%
NRTI, d4T, Partially sensitive
0
   0.0%
NRTI, d4T, Sensitive
1
 100.0%
NRTI, ddI, Resistant
0
   0.0%
NRTI, ddI, Partially sensitive
0
   0.0%
NRTI, ddI, Sensitive
1
 100.0%
PI, ATV/r, Resistant
0
   0.0%
PI, ATV/r, Partially sensitive
0
   0.0%
PI, ATV/r, Sensitive
1
 100.0%
PI, DRV/r, Resistant
0
   0.0%
PI, DRV/r, Partially sensitive
0
   0.0%
PI, DRV/r, Sensitive
1
 100.0%
PI, FPV/r, Resistant
0
   0.0%
PI, FPV/r, Partially sensitive
0
   0.0%
PI, FPV/r, Sensitive
1
 100.0%
PI, IDV/r, Resistant
0
   0.0%
PI, IDV/r, Partially sensitive
0
   0.0%
PI, IDV/r, Sensitive
1
 100.0%
PI, LPV/r, Resistant
0
   0.0%
PI, LPV/r, Partially sensitive
0
   0.0%
PI, LPV/r, Sensitive
1
 100.0%
PI, NFV, Resistant
0
   0.0%
PI, NFV, Partially sensitive
0
   0.0%
PI, NFV, Sensitive
1
 100.0%
PI, RTV, Resistant
0
   0.0%
PI, RTV, Partially sensitive
0
   0.0%
PI, RTV, Sensitive
1
 100.0%
PI, SQV/r, Resistant
0
   0.0%
PI, SQV/r, Partially sensitive
0
   0.0%
PI, SQV/r, Sensitive
1
 100.0%
PI, TPV/r, Resistant
0
   0.0%
PI, TPV/r, Partially sensitive
0
   0.0%
PI, TPV/r, Sensitive
1
 100.0%
26.Secondary Outcome
Title Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV - DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early+late switch phase. Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0).
Time Frame Pre-dose at Week 4, 24, 48, 56, 76 and 100
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG 50 mg RPV 25 mg
Hide Arm/Group Description:
Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 148 during early switch and late switch phase.
Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 148 during early switch and late switch phase.
Overall Number of Participants Analyzed 254 254
Mean (Standard Deviation)
Unit of Measure: ug/ L
Week 4, n=176, 175 Number Analyzed 176 participants 175 participants
1578.88  (1170.967) 79.50  (38.230)
Week 24, n=207, 207 Number Analyzed 207 participants 207 participants
1447.23  (917.677) 90.21  (46.302)
Week 48, n=215, 215 Number Analyzed 215 participants 215 participants
1384.36  (889.829) 91.41  (47.073)
Week 56, n=214, 213 Number Analyzed 214 participants 213 participants
1637.74  (1063.391) 90.55  (45.686)
Week 76, n=219, 219 Number Analyzed 219 participants 219 participants
1507.81  (913.263) 92.51  (46.223)
Week 100, n=220, 221 Number Analyzed 220 participants 221 participants
1532.10  (916.975) 91.98  (44.683)
27.Secondary Outcome
Title Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG + RPV - CAR Late Switch Group Through Late Switch Phase
Hide Description Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase. LS PK Parameter Population comprised of all participants who were randomized to CAR and received DTG + RPV in the Late Switch Phase and provided at least one evaluable estimate of C0.
Time Frame Pre-dose at Weeks 56, 76 and 100
Hide Outcome Measure Data
Hide Analysis Population Description
LS PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title CAR-DTG 50 mg CAR-RPV 25 mg
Hide Arm/Group Description:
Participants from CAR arm received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
Participants from CAR arm received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
Overall Number of Participants Analyzed 226 226
Mean (Standard Deviation)
Unit of Measure: ug/ L
Week 56, n=203, 203 Number Analyzed 203 participants 203 participants
1544.75  (1049.595) 77.27  (38.931)
Week 76, n=210, 210 Number Analyzed 210 participants 210 participants
1806.77  (1019.300) 91.46  (48.568)
Week 100, n=215, 215 Number Analyzed 215 participants 215 participants
1881.97  (1160.587) 90.89  (47.762)
28.Secondary Outcome
Title Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Hide Description Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.
Time Frame Pre-dose at Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG 50 mg RPV 25 mg
Hide Arm/Group Description:
Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ug/ L
Week 2, n=19, 19 Number Analyzed 19 participants 19 participants
834.58  (639.622) 57.342  (29.5436)
Week 4, n=22, 21 Number Analyzed 22 participants 21 participants
1218.23  (842.703) 78.338  (31.4825)
Week 8, n=26, 26 Number Analyzed 26 participants 26 participants
1472.50  (818.774) 79.652  (40.7546)
29.Secondary Outcome
Title Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
Hide Description Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Number
Unit of Measure: Percentage of participants
NNRTI, n=144, 144 Number Analyzed 144 participants 144 participants
97 93
INSTI, n=59, 49 Number Analyzed 59 participants 49 participants
92 94
PI, n=58, 62 Number Analyzed 58 participants 62 participants
91 97
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments One-sided p-value from weighted least squares chi-squared statistic. A p-value <=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.
Method Chi-squared, Corrected
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-1.6 to 8.6
Estimation Comments NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-12.1 to 7.4
Estimation Comments INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-13.9 to 3.1
Estimation Comments PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.
30.Secondary Outcome
Title Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Hide Description Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Cells per mm^3
NNRTI, n=139, 133 Number Analyzed 139 participants 133 participants
49.7  (166.40) 24.3  (160.32)
INSTI, n=53, 46 Number Analyzed 53 participants 46 participants
-11.2  (176.56) 10.3  (155.53)
PI, n=53, 61 Number Analyzed 53 participants 61 participants
10.5  (163.67) 12.2  (163.32)
31.Secondary Outcome
Title Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE, NNRTI, n=144, 144 Number Analyzed 144 participants 144 participants
106
  73.6%
96
  66.7%
Any AE, INSTI, n=59, 49 Number Analyzed 59 participants 49 participants
47
  79.7%
36
  73.5%
Any AE, PI, n=58, 62 Number Analyzed 58 participants 62 participants
42
  72.4%
42
  67.7%
NNRTI, Maximum toxicity Grade 1 AE, n=144, 144 Number Analyzed 144 participants 144 participants
68
  47.2%
76
  52.8%
NNRTI, Maximum toxicity Grade 2 AE, n=144, 144 Number Analyzed 144 participants 144 participants
30
  20.8%
19
  13.2%
NNRTI, Maximum toxicity Grade 3 AE, n=144, 144 Number Analyzed 144 participants 144 participants
8
   5.6%
0
   0.0%
NNRTI, Maximum toxicity Grade 4 AE, n=144, 144 Number Analyzed 144 participants 144 participants
0
   0.0%
1
   0.7%
INSTI, Maximum toxicity Grade 1 AE, n=59, 49 Number Analyzed 59 participants 49 participants
27
  45.8%
20
  40.8%
INSTI, Maximum toxicity Grade 2 AE, n=59, 49 Number Analyzed 59 participants 49 participants
15
  25.4%
15
  30.6%
INSTI, Maximum toxicity Grade 3 AE, n=59, 49 Number Analyzed 59 participants 49 participants
5
   8.5%
1
   2.0%
INSTI, Maximum toxicity Grade 4 AE, n=59, 49 Number Analyzed 59 participants 49 participants
0
   0.0%
0
   0.0%
PI, Maximum toxicity Grade 1 AE, n=58, 62 Number Analyzed 58 participants 62 participants
24
  41.4%
26
  41.9%
PI, Maximum toxicity Grade 2 AE, n=58, 62 Number Analyzed 58 participants 62 participants
14
  24.1%
13
  21.0%
PI, Maximum toxicity Grade 3 AE, n=58, 62 Number Analyzed 58 participants 62 participants
3
   5.2%
3
   4.8%
PI, Maximum toxicity Grade 4 AE, n=58, 62 Number Analyzed 58 participants 62 participants
1
   1.7%
0
   0.0%
AELD, NNRTI, n=144, 144 Number Analyzed 144 participants 144 participants
5
   3.5%
1
   0.7%
AELD, INSTI, n=59, 49 Number Analyzed 59 participants 49 participants
4
   6.8%
0
   0.0%
AELD, PI, n=58, 62 Number Analyzed 58 participants 62 participants
3
   5.2%
0
   0.0%
32.Secondary Outcome
Title Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Hide Description Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Count of Participants
Unit of Measure: Participants
NNRTI, Grade 1, n=144, 144 Number Analyzed 144 participants 144 participants
51
  35.4%
52
  36.1%
NNRTI, Grade 2, n=144, 144 Number Analyzed 144 participants 144 participants
31
  21.5%
40
  27.8%
NNRTI, Grade 3, n=144, 144 Number Analyzed 144 participants 144 participants
7
   4.9%
4
   2.8%
NNRTI, Grade 4, n=144, 144 Number Analyzed 144 participants 144 participants
1
   0.7%
5
   3.5%
INSTI, Grade 1, n= 59, 49 Number Analyzed 59 participants 49 participants
19
  32.2%
11
  22.4%
INSTI, Grade 2, n=59, 49 Number Analyzed 59 participants 49 participants
23
  39.0%
18
  36.7%
INSTI, Grade 3, n= 59, 49 Number Analyzed 59 participants 49 participants
3
   5.1%
3
   6.1%
INSTI, Grade 4, n= 59, 49 Number Analyzed 59 participants 49 participants
0
   0.0%
2
   4.1%
PI, Grade 1, n= 58, 62 Number Analyzed 58 participants 62 participants
22
  37.9%
17
  27.4%
PI, Grade 2, n= 58, 62 Number Analyzed 58 participants 62 participants
18
  31.0%
21
  33.9%
PI, Grade 3, n= 58, 62 Number Analyzed 58 participants 62 participants
1
   1.7%
9
  14.5%
PI, Grade 4, n= 58, 62 Number Analyzed 58 participants 62 participants
0
   0.0%
3
   4.8%
33.Secondary Outcome
Title Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Hide Description Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Measure Type: Count of Participants
Unit of Measure: Participants
NNRTI; Grade 1; n= 144, 144 Number Analyzed 144 participants 144 participants
7
   4.9%
6
   4.2%
NNRTI; Grade 2; n= 144, 144 Number Analyzed 144 participants 144 participants
1
   0.7%
2
   1.4%
NNRTI; Grade 3; n= 144, 144 Number Analyzed 144 participants 144 participants
1
   0.7%
0
   0.0%
NNRTI; Grade 4; n= 144, 144 Number Analyzed 144 participants 144 participants
1
   0.7%
0
   0.0%
INI; Grade 1; n-= 59, 49 Number Analyzed 59 participants 49 participants
1
   1.7%
1
   2.0%
INI; Grade 2; n-= 59, 49 Number Analyzed 59 participants 49 participants
0
   0.0%
0
   0.0%
INI; Grade 3; n-= 59, 49 Number Analyzed 59 participants 49 participants
0
   0.0%
0
   0.0%
INI; Grade 4; n-= 59, 49 Number Analyzed 59 participants 49 participants
0
   0.0%
0
   0.0%
PI; Grade 1; n= 58, 62 Number Analyzed 58 participants 62 participants
3
   5.2%
4
   6.5%
PI; Grade 2; n= 58, 62 Number Analyzed 58 participants 62 participants
1
   1.7%
0
   0.0%
PI; Grade 3; n= 58, 62 Number Analyzed 58 participants 62 participants
2
   3.4%
0
   0.0%
PI; Grade 4; n= 58, 62 Number Analyzed 58 participants 62 participants
0
   0.0%
0
   0.0%
34.Secondary Outcome
Title Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
Hide Description For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
CVW resistance Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
35.Secondary Outcome
Title Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
Hide Description For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
CVW resistance Population
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
36.Secondary Outcome
Title Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Hide Description Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1), Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: mmol/L
CHO, Week 24, overall, n=237, 229 Number Analyzed 237 participants 229 participants
1.015  (15.7472) 1.300  (12.2269)
CHO, Week 48, overall, n=237, 230 Number Analyzed 237 participants 230 participants
-0.165  (15.9301) 0.194  (13.1071)
CHO, Week 24, NNRTI, n=0, 132 Number Analyzed 0 participants 132 participants
1.238  (12.4889)
CHO, Week 48, NNRTI, n=0, 128 Number Analyzed 0 participants 128 participants
0.281  (12.2469)
CHO, Week 24, INSTI, n=0, 42 Number Analyzed 0 participants 42 participants
1.973  (12.1365)
CHO, Week 48, INSTI, n=0, 44 Number Analyzed 0 participants 44 participants
2.798  (16.1468)
CHO, Week 24, PI, n=0, 55 Number Analyzed 0 participants 55 participants
0.936  (11.8530)
CHO, Week 48, PI, n=0, 58 Number Analyzed 0 participants 58 participants
-1.971  (12.2195)
HDL CHO direct, Overall, Week 24, n=237, 229 Number Analyzed 237 participants 229 participants
0.557  (19.4929) -2.533  (16.3641)
HDL CHO direct, Overall, Week 48, n=237,230 Number Analyzed 237 participants 230 participants
6.384  (20.9244) 4.723  (18.3253)
HDL CHO direct, NNRTI, Week 24, n=0, 132 Number Analyzed 0 participants 132 participants
-2.562  (15.3521)
HDL CHO direct, NNRTI, Week 48, n=0, 128 Number Analyzed 0 participants 128 participants
4.307  (17.8013)
HDL CHO direct, INSTI, Week 24, n=0, 42 Number Analyzed 0 participants 42 participants
-3.097  (20.0002)
HDL CHO direct, INSTI, Week 48, n=0, 44 Number Analyzed 0 participants 44 participants
5.386  (20.6791)
HDL CHO direct, PI, Week 24, n=0, 55 Number Analyzed 0 participants 55 participants
-2.031  (15.9582)
HDL CHO direct, PI, Week 48, n=0, 58 Number Analyzed 0 participants 58 participants
5.140  (17.8779)
LDL CHO calculation, Overall, Week 24, n=231, 221 Number Analyzed 231 participants 221 participants
5.838  (22.9614) 4.395  (21.6685)
LDL CHO calculation, Overall, Week 48, n=229, 220 Number Analyzed 229 participants 220 participants
1.137  (23.3849) -0.598  (20.6931)
LDL CHO calculation, NNRTI, Week 24, n=0, 129 Number Analyzed 0 participants 129 participants
5.959  (21.5692)
LDL CHO calculation, NNRTI, Week 48, n=0, 124 Number Analyzed 0 participants 124 participants
0.747  (19.2299)
LDL CHO calculation, INSTI, Week 24, n=0, 40 Number Analyzed 0 participants 40 participants
3.787  (17.6755)
LDL CHO calculation, INSTI, Week 48, n=0, 42 Number Analyzed 0 participants 42 participants
2.647  (24.0430)
LDL CHO calculation, PI, Week 24, n=0, 52 Number Analyzed 0 participants 52 participants
0.983  (24.5052)
LDL CHO calculation, PI, Week 48, n=0, 54 Number Analyzed 0 participants 54 participants
-6.212  (20.4774)
Triglycerides, Overall, Week 24, n=237, 229 Number Analyzed 237 participants 229 participants
-0.825  (42.5565) 9.379  (45.5529)
Triglycerides, Overall, Week 48, n=237, 230 Number Analyzed 237 participants 230 participants
1.169  (51.9844) 7.183  (44.7044)
Triglycerides, NNRTI, Week 24, n=0, 132 Number Analyzed 0 participants 132 participants
4.962  (40.6201)
Triglycerides, NNRTI, Week 48, n=0, 128 Number Analyzed 0 participants 128 participants
5.248  (41.7728)
Triglycerides, INSTI, Week 24, n=0, 42 Number Analyzed 0 participants 42 participants
18.204  (47.2348)
Triglycerides, INSTI, Week 48, n=0, 44 Number Analyzed 0 participants 44 participants
14.627  (56.2824)
Triglycerides, PI, Week 24, n=0,55 Number Analyzed 0 participants 55 participants
13.241  (54.2327)
Triglycerides, PI, Week 48, n=0, 58 Number Analyzed 0 participants 58 participants
5.806  (41.2106)
37.Secondary Outcome
Title Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Hide Description The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1), Weeks 4, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 261 255
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Symptom count, Week 4, n=224, 229 Number Analyzed 224 participants 229 participants
-1.1  (4.11) -0.8  (4.02)
Symptom count, Week 24, n=228, 232 Number Analyzed 228 participants 232 participants
-0.7  (4.31) -0.8  (4.64)
Symptom count, Week 48, n=228, 231 Number Analyzed 228 participants 231 participants
-0.5  (4.33) -0.4  (4.82)
Symptom Bother Score, Week 4, n=224, 229 Number Analyzed 224 participants 229 participants
-2.8  (7.44) -1.8  (7.24)
Symptom Bother Score, Week 24, n=228, 232 Number Analyzed 228 participants 232 participants
-1.8  (8.40) -1.7  (8.72)
Symptom Bother Score, Week 48, n=228, 231 Number Analyzed 228 participants 231 participants
-1.5  (7.97) -0.7  (9.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments P-value for interaction between treatment group and Baseline symptom bother score (Week 4)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P value to assess difference between treatment groups (Symptom Bother Score - Week 4)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.239
Confidence Interval (2-Sided) 95%
-2.414 to -0.064
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.542
Comments P-value for interaction between treatment group and Baseline symptom bother score (Week 24)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments P value to assess difference between treatment groups (Symptom Bother Score - Week 24)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.528
Confidence Interval (2-Sided) 95%
-1.896 to 0.840
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments P-value for interaction between treatment group and Baseline symptom bother score (Week 48)
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments P value to assess difference between treatment groups (Symptom Bother Score - Week 48)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.037
Confidence Interval (2-Sided) 95%
-2.501 to 0.426
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.
38.Secondary Outcome
Title Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1), Weeks 56, 76, 100 and 148
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Overall Number of Participants Analyzed 228
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Symptom count, Week 56 -0.8  (4.80)
Symptom count, Week 76 -0.6  (4.66)
Symptom count, Week 100 -0.5  (5.03)
Symptom count, Week 148 -0.7  (4.87)
Symptom Bother Score, Week 56 -1.8  (9.23)
Symptom Bother Score, Week 76 -1.6  (8.70)
Symptom Bother Score, Week 100 -1.4  (9.40)
Symptom Bother Score, Week 148 -1.7  (9.54)
39.Secondary Outcome
Title Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase
Hide Description The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Time Frame LS Baseline (Week 48), Weeks 56, 76, 100 and 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed 239
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Symptom count, Week 56, n=216 Number Analyzed 216 participants
-0.9  (4.74)
Symptom count, Week 76, n=220 Number Analyzed 220 participants
-0.7  (4.29)
Symptom count, Week 100, n=220 Number Analyzed 220 participants
-0.4  (5.04)
Symptom count, Week 148, n=220 Number Analyzed 220 participants
-0.6  (4.81)
Symptom Bother Score, Week 56 n=216 Number Analyzed 216 participants
-2.1  (7.56)
Symptom Bother Score, Week 76, n=220 Number Analyzed 220 participants
-1.0  (7.61)
Symptom Bother Score, Week 100, n=220 Number Analyzed 220 participants
-0.8  (8.43)
Symptom Bother Score, Week 148, n=220 Number Analyzed 220 participants
-1.0  (8.54)
40.Secondary Outcome
Title Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase