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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-1)

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ClinicalTrials.gov Identifier: NCT02429791
Recruitment Status : Active, not recruiting
First Posted : April 29, 2015
Results First Posted : December 2, 2017
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: DTG 50 mg
Drug: RPV 25 mg
Drug: CAR
Enrollment 510
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 in 65 centers in 13 countries.
Pre-assignment Details Total 669 participants were screened (159 failed), 510 participants were randomized and 2 subjects 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 Early Switch Phase.
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Period Title: Overall Study
Started 252 256
Completed 239 238
Not Completed 13 18
Reason Not Completed
Adverse Event             6             2
Physician Decision             0             2
Lack of Efficacy             2             1
Lost to Follow-up             1             2
Protocol Violation             1             4
Withdrawal by Subject             3             7
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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. Total of all reporting groups
Overall Number of Baseline Participants 252 256 508
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 252 participants 256 participants 508 participants
43.6  (10.93) 43.6  (10.76) 43.6  (10.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 256 participants 508 participants
Female
58
  23.0%
51
  19.9%
109
  21.5%
Male
194
  77.0%
205
  80.1%
399
  78.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 252 participants 256 participants 508 participants
American Indian or Alaska Native 3 6 9
Japanese/East Asian (EA) Heritage (H.)/South EA H. 25 34 59
Black/African American 24 27 51
Native Hawaiian or other Pacific Islander 1 0 1
White 198 188 386
American Indian or Alaska Native and white 0 1 1
African American/African H. and Asian 1 0 1
1.Primary Outcome
Title Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (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 HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. Treatment with DTG + RPV was declared non-inferior to CAR if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 lies above -10% by Cochran-Mantel Haenszel test. 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
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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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Percentage of participants
95 96
Show Statistical Analysis 1 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 -0.6
Confidence Interval (2-Sided) 95%
-4.3 to 3.0
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, INI).
2.Secondary Outcome
Title Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Hide Description Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Week 24 and 48
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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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Cells per millimeter (mm)^3
Week 24, n=247, 249 Number Analyzed 247 participants 249 participants
16.2  (150.34) 47.4  (179.68)
Week 48, n=239, 245 Number Analyzed 239 participants 245 participants
32.3  (149.52) 41.8  (185.53)
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 HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12 and 24.
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Percentage of participants
98 96
Show Statistical Analysis 1 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 1.0
Confidence Interval (2-Sided) 95%
-1.9 to 4.0
Estimation Comments Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INI). 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, AE Leading to Discontinuation (AELD)
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. 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. Number of participants with common non-serious AE, SAE, AELD or AE with maximum grade toxicity experienced over Week 48 was summarized. Common AEs were those with >5 percent incidence for either treatment. Safety Population included all randomly assigned participants who have received at least one dose of study drug.
Time Frame Up to 52 weeks
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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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Participants
Common non-serious AE 65 68
Any SAE 9 12
Maximum Grade 1 AE 128 122
Maximum toxicity Grade 2 AE 57 53
Maximum toxicity Grade 3 AE 11 13
Maximum toxicity Grade 4 AE 4 2
AELD 9 2
5.Secondary Outcome
Title Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Hide Description Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 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. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Participants 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; grade 4=potentially life-threatening.
Time Frame Up to 48 weeks
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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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Participants
Grade 1 95 78
Grade 2 61 86
Grade 3 22 23
Grade 4 5 9
6.Secondary Outcome
Title Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Hide Description Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 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. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Participants 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; grade 4=potentially life-threatening
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Participants
Grade 1 11 11
Grade 2 3 2
Grade 3 3 1
Grade 4 0 1
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 Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 234 243
Mean (Standard Deviation)
Unit of Measure: mg/ Liter (L)
0.11  (5.379) 0.15  (4.944)
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 Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 237 245
Mean (Standard Deviation)
Unit of Measure: mg/L
-0.00  (0.113) -0.01  (0.106)
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 Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 224 238
Mean (Standard Deviation)
Unit of Measure: Nanomole (nmol)/L FEU
-0.02  (2.651) 0.02  (2.501)
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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Nanogram/milliliter
FABP, n=233, 242 Number Analyzed 233 participants 242 participants
-2.79  (3.007) -1.93  (2.150)
Soluble CD14, n=234, 242 Number Analyzed 234 participants 242 participants
379.72  (634.053) 754.54  (656.462)
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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Microgram (ug)/Liter
Soluble CD163, n=232, 241 Number Analyzed 232 participants 241 participants
50.18  (188.772) 54.26  (238.900)
Oxidized LDL, n=234, 242 Number Analyzed 234 participants 242 participants
9.49  (745.962) -41.30  (726.014)
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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: mg/ deciliter (dL)
RBP, n=235, 243 Number Analyzed 235 participants 243 participants
-0.13  (1.023) 0.03  (0.974)
Serum creatinine, n=238, 243 Number Analyzed 238 participants 243 participants
0.087  (0.1074) 0.011  (0.0876)
Glucose, n=227, 227 Number Analyzed 227 participants 227 participants
0.762  (13.6194) 2.492  (12.1674)
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 Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 218 224
Mean (Standard Deviation)
Unit of Measure: Millimoles (mmol)/ L
-1.079  (16.9226) -1.511  (15.8515)
14.Secondary Outcome
Title Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D 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 at Baseline (Day 1) and Week 48 to assess urine B2M and urine RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). 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 Up to Week 48
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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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Nanomoles (nmol)/ L
B2M, blood, n=233, 241 Number Analyzed 233 participants 241 participants
-15.1452  (44.55903) -4.5995  (38.90474)
25 hydroxy-vitamin D, n=235, 244 Number Analyzed 235 participants 244 participants
-13.9  (22.76) -8.2  (24.43)
Urine B2M, n=89, 96 Number Analyzed 89 participants 96 participants
-128.2045  (726.38825) 39.8394  (253.43025)
Urine RBP, n=221, 231 Number Analyzed 221 participants 231 participants
-8.8395  (28.83977) -0.5851  (27.56405)
Show Statistical Analysis 1 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 Since statistical significance at the 10% level was observed, results are presented separately per Baseline third agent.
Show Statistical Analysis 2 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 0.275
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 0.958
Confidence Interval (2-Sided) 95%
0.888 to 1.034
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.
Show Statistical Analysis 3 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 0.112
Comments P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.902
Confidence Interval (2-Sided) 95%
0.793 to 1.025
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.
Show Statistical Analysis 4 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 0.002
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 0.847
Confidence Interval (2-Sided) 95%
0.763 to 0.942
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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to Week 48
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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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Grams (g)/ mol
Urine albumin/creatinine ratio, n=166, 171 Number Analyzed 166 participants 171 participants
-1.19  (3.916) -2.59  (28.878)
urine protein/creatinine ratio, n=176, 182 Number Analyzed 176 participants 182 participants
-5.63  (17.219) -1.43  (42.832)
16.Secondary Outcome
Title Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I 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 I Collagen C-Telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). 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 Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: ug/ L
Bone-specific alkaline phosphatase, n=234, 244 Number Analyzed 234 participants 244 participants
-2.89  (4.024) 0.90  (4.129)
Procollagen type 1 N-propeptide, n=234, 242 Number Analyzed 234 participants 242 participants
-9.1  (20.34) -1.4  (18.95)
Osteocalcin, n=233, 242 Number Analyzed 233 participants 242 participants
-4.40  (7.605) -0.68  (6.579)
Type I Collagen C-Telopeptides, n=234, 241 Number Analyzed 234 participants 241 participants
-0.18  (0.307) -0.04  (1.160)
sVCAM, n=234, 243 Number Analyzed 234 participants 243 participants
-2.21  (1291.994) 89.07  (1239.465)
Show Statistical Analysis 1 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 Since statistical significance at the 10% level was observed, results are presented separately per Baseline third agent.
Show Statistical Analysis 2 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 0.724
Confidence Interval (2-Sided) 95%
0.679 to 0.772
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.
Show Statistical Analysis 3 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 <.001
Comments P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.825
Confidence Interval (2-Sided) 95%
0.742 to 0.918
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.
Show Statistical Analysis 4 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 0.810
Confidence Interval (2-Sided) 95%
0.742 to 0.884
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.
Show Statistical Analysis 5 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 Since statistical significance at the 10% level was not observed, results are presented overall only.
Show Statistical Analysis 6 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 0.817
Confidence Interval (2-Sided) 95%
0.774 to 0.863
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.
Show Statistical Analysis 7 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 Since statistical significance at the 10% level was observed, results are presented separately per Baseline third agent.
Show Statistical Analysis 8 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 0.881
Confidence Interval (2-Sided) 95%
0.823 to 0.943
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.
Show Statistical Analysis 9 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 0.001
Comments P value to assess difference between treatment groups (osteocalcin - INI)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.829
Confidence Interval (2-Sided) 95%
0.740 to 0.930
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.
Show Statistical Analysis 10 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 0.691
Confidence Interval (2-Sided) 95%
0.628 to 0.759
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.
Show Statistical Analysis 11 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 Since statistical significance at the 10% level was not observed, results are presented overall only.
Show Statistical Analysis 12 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 0.804
Confidence Interval (2-Sided) 95%
0.742 to 0.872
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 Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 233 243
Mean (Standard Deviation)
Unit of Measure: Nanograms (ng)/ L
0.17  (2.736) -0.18  (2.944)
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 (1,2), is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Time Frame Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 229 237
Mean (Standard Deviation)
Unit of Measure: HOMA-IR Score
-0.30  (5.740) 0.51  (3.530)
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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: mmol/ L
Total cholesterol, Week 24, n=228, 223 Number Analyzed 228 participants 223 participants
0.076  (0.8398) 0.061  (0.7368)
Total cholesterol, Week 48, n=221, 218 Number Analyzed 221 participants 218 participants
0.089  (0.8488) 0.064  (0.7197)
LDL cholesterol calculation, Week 24, n=224, 217 Number Analyzed 224 participants 217 participants
0.165  (0.7065) 0.103  (0.6503)
LDL cholesterol calculation, Week 48, n=215, 211 Number Analyzed 215 participants 211 participants
0.108  (0.7178) 0.029  (0.6134)
HDL cholesterol direct, Week 24, n=228, 223 Number Analyzed 228 participants 223 participants
-0.030  (0.2601) -0.044  (0.2394)
HDL cholesterol direct, Week 48, n=221, 218 Number Analyzed 221 participants 218 participants
0.023  (0.2757) 0.018  (0.2722)
Triglycerides, Week 24, n=228, 223 Number Analyzed 228 participants 223 participants
-0.154  (0.7324) -0.001  (0.7712)
Triglycerides, Week 48, n=221, 218 Number Analyzed 221 participants 218 participants
-0.093  (0.9767) 0.046  (0.8274)
20.Secondary Outcome
Title Genotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria
Hide Description Genotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicate that data were not applicable based on drugs not received. Genotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
CVW 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Participants
NNRTI, RPV, Susceptible 1 NA [1] 
NNRTI, RPV, Potential low-level resistance 0 NA [1] 
NNRTI, RPV, Low-level resistance 0 NA [1] 
NNRTI, RPV, Intermediate resistance 0 NA [1] 
NNRTI, RPV, High-level resistance 0 NA [1] 
INI, DTG, Susceptible 1 NA [1] 
INI, DTG, Potential low-level resistance 0 NA [1] 
INI, DTG, Low-level resistance 0 NA [1] 
INI, DTG, Intermediate resistance 0 NA [1] 
INI, DTG, High-level resistance 0 NA [1] 
NRTI, FTC, Susceptible NA [1]  1
NRTI, FTC, Potential low-level resistance NA [1]  0
NRTI, FTC, Low-level resistance NA [1]  0
NRTI, FTC, Intermediate resistance NA [1]  0
NRTI, FTC, High-level resistance NA [1]  0
NRTI, TDF, Susceptible NA [1]  1
NRTI, TDF, Potential low-level resistance NA [1]  0
NRTI, TDF, Low-level resistance NA [1]  0
NRTI, TDF, Intermediate resistance NA [1]  0
NRTI, TDF, High-level resistance NA [1]  0
PI, DRV/r, Susceptible NA [1]  1
PI, DRV/r, Potential low-level resistance NA [1]  0
PI, DRV/r, Low-level resistance NA [1]  0
PI, DRV/r, Intermediate resistance NA [1]  0
PI, DRV/r, High-level resistance NA [1]  0
[1]
NA indicates data was not applicable based on drugs were not received. Genotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria
21.Secondary Outcome
Title Phenotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria
Hide Description Phenotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicate that data were not applicable based on drugs were not received. Phenotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
CVW 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Participants
INI, DTG, Resistant 0 NA [1] 
INI, DTG, Partially Sensitive 0 NA [1] 
INI, DTG, Sensitive 1 NA [1] 
INI, RAL, Resistant NA [1]  NA [1] 
INI, RAL, Sensitive NA [1]  NA [1] 
INI, EVG, Resistant NA [1]  NA [1] 
INI, EVG, Sensitive NA [1]  NA [1] 
NNRTI, RPV, Resistant 0 NA [1] 
NNRTI, RPV, Sensitive 1 NA [1] 
NNRTI, ETR, Resistant NA [1]  NA [1] 
NNRTI, ETR, Partially Sensitive NA [1]  NA [1] 
NNRTI, ETR, Sensitive NA [1]  NA [1] 
NRTI, 3TC, Resistant NA [1]  NA [1] 
NRTI, 3TC, Sensitive NA [1]  NA [1] 
NRTI, ABC, Resistant NA [1]  NA [1] 
NRTI, ABC, Partially Sensitive NA [1]  NA [1] 
NRTI, ABC, Sensitive NA [1]  NA [1] 
NRTI,FTC, Resistant NA [1]  0
NRTI, FTC, Sensitive NA [1]  1
NRTI, TDF, Resistant NA [1]  0
NRTI, TDF, Partially Sensitive NA [1]  0
NRTI, TDF, Sensitive NA [1]  1
NRTI, d4T, Resistant NA [1]  NA [1] 
NRTI, d4T, Sensitive NA [1]  NA [1] 
NRTI, ddI, Resistant NA [1]  NA [1] 
NRTI, ddI, Partially Sensitive NA [1]  NA [1] 
NRTI, ddI, Sensitive NA [1]  NA [1] 
PI, ATV/r, Resistant NA [1]  NA [1] 
PI, ATV/r, Sensitive NA [1]  NA [1] 
PI, DRV/r, Resistant NA [1]  0
PI, DRV/r, Partially Sensitive NA [1]  0
PI, DRV/r, Sensitive NA [1]  1
PI, FPV/r, Resistant NA [1]  NA [1] 
PI, FPV/r, Partially Sensitive NA [1]  NA [1] 
PI, FPV/r, Sensitive NA [1]  NA [1] 
PI, IDV/r, Resistant NA [1]  NA [1] 
PI, IDV/r, Sensitive NA [1]  NA [1] 
PI, LPV/r, Resistant NA [1]  NA [1] 
PI, LPV/r, Partially Sensitive NA [1]  NA [1] 
PI, LPV/r, Sensitive NA [1]  NA [1] 
PI, SQV/r, Resistant NA [1]  NA [1] 
PI, SQV/r, Partially Sensitive NA [1]  NA [1] 
PI, SQV/r, Sensitive NA [1]  NA [1] 
PI, TPV/r, Resistant NA [1]  NA [1] 
PI, TPV/r, Partially Sensitive NA [1]  NA [1] 
PI, TPV/r, Sensitive NA [1]  NA [1] 
[1]
NA indicate that data were not applicable based on drugs were not received. Phenotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria
22.Secondary Outcome
Title Pre-dose Concentrations of DTG and RPV at Weeks 4, 24 and 48 or Withdrawal in Participants Switching to DTG + RPV
Hide Description Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24 and 48. Pre-dose concentrations of DTG and RPV at Weeks 4, 24 and 48 or withdrawal were summarized for the participants switching to DTG + RPV in the early switch phase. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). 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 and 48 or at withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
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 239 239
Mean (Standard Deviation)
Unit of Measure: ug/ L
Week 4, n=130, 130 Number Analyzed 130 participants 130 participants
1581.06  (1146.860) 92.046  (138.2880)
Week 24, n=210, 210 Number Analyzed 210 participants 210 participants
1835.68  (1120.539) 87.875  (39.1412)
Week 48, n=215, 211 Number Analyzed 215 participants 211 participants
1915.11  (1304.238) 95.405  (48.2978)
23.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. 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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Pre-dose at Week 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter NNRTI Subset extra sampling Population
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 26 26
Mean (Standard Deviation)
Unit of Measure: ug/ L
Week 2, n=16, 15 Number Analyzed 16 participants 15 participants
821.25  (574.607) 65.360  (31.2965)
Week 4, n=19, 19 Number Analyzed 19 participants 19 participants
994.00  (581.201) 67.374  (27.5663)
Week 8, n=19, 19 Number Analyzed 19 participants 19 participants
1561.34  (1096.381) 77.416  (37.7129)
24.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 (INI, NNRTI, or PI) on efficacy 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 and age group. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Percentage of participants
NNRTI, n=131, 134 Number Analyzed 131 participants 134 participants
95 98
INI, n=46, 48 Number Analyzed 46 participants 48 participants
98 96
PI, n=75, 74 Number Analyzed 75 participants 74 participants
95 92
Show Statistical Analysis 1 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 0.317
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]
Show Statistical Analysis 2 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 -3.1
Confidence Interval (2-Sided) 95%
-7.7 to 1.5
Estimation Comments NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.
Show Statistical Analysis 3 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 2.0
Confidence Interval (2-Sided) 95%
-5.1 to 9.0
Estimation Comments INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.
Show Statistical Analysis 4 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 2.8
Confidence Interval (2-Sided) 95%
-5.3 to 10.8
Estimation Comments PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.
25.Secondary Outcome
Title Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Hide Description Blood for CD4 cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Cells per mm^3
NNRTI, n=124, 130 Number Analyzed 124 participants 130 participants
47.9  (142.90) 25.0  (151.27)
INI, n=45, 46 Number Analyzed 45 participants 46 participants
19.9  (148.63) 39.9  (200.38)
PI, n=70, 69 Number Analyzed 70 participants 69 participants
12.5  (160.27) 74.7  (227.78)
26.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 (INI, NNRTI, or PI) was summarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Participants
Any AE, NNRTI, n=131, 134 Number Analyzed 131 participants 134 participants
102 98
Any AE, INI, n=46, 48 Number Analyzed 46 participants 48 participants
38 34
Any AE, PI, n=75, 74 Number Analyzed 75 participants 74 participants
60 58
NNRTI, Maximum toxicity Grade 1 AE, n=131, 134 Number Analyzed 131 participants 134 participants
69 72
NNRTI, Maximum toxicity Grade 2 AE, n=131, 134 Number Analyzed 131 participants 134 participants
27 23
NNRTI, Maximum toxicity Grade 3 AE, n=131, 134 Number Analyzed 131 participants 134 participants
5 2
NNRTI, Maximum toxicity Grade 4 AE, n=131, 134 Number Analyzed 131 participants 134 participants
1 1
INI, Maximum toxicity Grade 1 AE, n=46, 48 Number Analyzed 46 participants 48 participants
28 20
INI, Maximum toxicity Grade 2 AE, n=46, 48 Number Analyzed 46 participants 48 participants
7 12
INI, Maximum toxicity Grade 3 AE, n=46, 48 Number Analyzed 46 participants 48 participants
2 2
INI, Maximum toxicity Grade 4 AE, n=46, 48 Number Analyzed 46 participants 48 participants
1 0
PI, Maximum toxicity Grade 1 AE, n=75, 74 Number Analyzed 75 participants 74 participants
31 30
PI, Maximum toxicity Grade 2 AE, n=75, 74 Number Analyzed 75 participants 74 participants
23 18
PI, Maximum toxicity Grade 3 AE, n=75, 74 Number Analyzed 75 participants 74 participants
4 9
PI, Maximum toxicity Grade 4 AE, n=75, 74 Number Analyzed 75 participants 74 participants
2 1
AELD, NNRTI, n=131, 134 Number Analyzed 131 participants 134 participants
3 0
AELD, INI, n=46, 48 Number Analyzed 46 participants 48 participants
2 0
AELD, PI, n=75, 74 Number Analyzed 75 participants 74 participants
4 2
27.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 Week 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. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INI, NNRTI, PI) was summarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Participants
NNRTI, Grades 1, n=131, 134 Number Analyzed 131 participants 134 participants
47 42
NNRTI, Grades 2, n=131, 134 Number Analyzed 131 participants 134 participants
32 48
NNRTI, Grades 3, n=131, 134 Number Analyzed 131 participants 134 participants
13 13
NNRTI, Grades 4, n=131, 134 Number Analyzed 131 participants 134 participants
2 3
INI, Grades 1, n= 46, 48 Number Analyzed 46 participants 48 participants
13 11
INI, Grades 2, n= 46, 48 Number Analyzed 46 participants 48 participants
19 15
INI, Grades 3, n= 46, 48 Number Analyzed 46 participants 48 participants
1 1
INI, Grades 4, n= 46, 48 Number Analyzed 46 participants 48 participants
3 2
PI, Grades 1, n= 75, 74 Number Analyzed 75 participants 74 participants
35 25
PI, Grades 2, n= 75, 74 Number Analyzed 75 participants 74 participants
10 23
PI, Grades 3, n= 75, 74 Number Analyzed 75 participants 74 participants
8 9
PI, Grades 4, n= 75, 74 Number Analyzed 75 participants 74 participants
0 4
28.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 Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. 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. Participants 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; grade 4=potentially life-threatening
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Measure Type: Number
Unit of Measure: Participants
NNRTI; Grade 1; n= 131, 134 Number Analyzed 131 participants 134 participants
5 3
NNRTI; Grade 2; n= 131, 134 Number Analyzed 131 participants 134 participants
1 1
NNRTI; Grade 3; n= 131, 134 Number Analyzed 131 participants 134 participants
1 1
NNRTI; Grade 4; n= 131, 134 Number Analyzed 131 participants 134 participants
0 1
INI; Grade 1; n= 46, 48 Number Analyzed 46 participants 48 participants
2 2
INI; Grade 2; n= 46, 48 Number Analyzed 46 participants 48 participants
1 0
INI; Grade 3; n= 46, 48 Number Analyzed 46 participants 48 participants
0 0
INI; Grade 4; n= 46, 48 Number Analyzed 46 participants 48 participants
0 0
PI; Grade 1; n= 75, 74 Number Analyzed 75 participants 74 participants
4 6
PI; Grade 2; n= 75, 74 Number Analyzed 75 participants 74 participants
1 1
PI; Grade 3; n= 75, 74 Number Analyzed 75 participants 74 participants
2 0
PI; Grade 4; n= 75, 74 Number Analyzed 75 participants 74 participants
0 0
29.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 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
CVW 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.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 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
CVW 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
31.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), 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. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to Week 48
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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: mmol/ mL
CHO, Week 24, overall, n=228, 223 Number Analyzed 228 participants 223 participants
3.239  (18.1556) 2.375  (14.8357)
CHO, Week 48, overall, n=221, 218 Number Analyzed 221 participants 218 participants
3.596  (18.7072) 2.472  (14.7202)
CHO, Week 24, NNRTI, n=0, 118 Number Analyzed 0 participants 118 participants
3.383  (13.3685)
CHO, Week 48, NNRTI, n=0, 118 Number Analyzed 0 participants 118 participants
4.099  (13.8992)
CHO, Week 24, INI, n=0, 44 Number Analyzed 0 participants 44 participants
1.288  (14.8933)
CHO, Week 48, INI, n=0, 43 Number Analyzed 0 participants 43 participants
0.524  (15.3143)
CHO, Week 24, PI, n=0, 61 Number Analyzed 0 participants 61 participants
1.211  (17.3972)
CHO, Week 48, PI, n=0, 57 Number Analyzed 0 participants 57 participants
0.575  (15.7475)
HDL CHO direct, Overall, Week 24, n=228, 223 Number Analyzed 228 participants 223 participants
0.017  (18.7575) -2.478  (16.6754)
HDL CHO direct, Overall, Week 48, n=221, 218 Number Analyzed 221 participants 218 participants
3.975  (21.1039) 3.095  (18.8909)
HDL CHO direct, NNRTI, Week 24, n=0, 118 Number Analyzed 0 participants 118 participants
0.062  (15.9300)
HDL CHO direct, NNRTI, Week 48, n=0, 118 Number Analyzed 0 participants 118 participants
4.818  (16.2253)
HDL CHO direct, INI, Week 24, n=0, 44 Number Analyzed 0 participants 44 participants
-4.968  (16.2973)
HDL CHO direct, INI, Week 48, n=0, 43 Number Analyzed 0 participants 43 participants
0.539  (22.6496)
HDL CHO direct, PI, Week 24, n=0, 61 Number Analyzed 0 participants 61 participants
-5.594  (17.7923)
HDL CHO direct, PI, Week 48, n=0, 57 Number Analyzed 0 participants 57 participants
1.457  (20.8346)
LDL CHO calculation, Overall, Week 24, n=224, 217 Number Analyzed 224 participants 217 participants
11.504  (36.9087) 6.196  (24.0104)
LDL CHO calculation, Overall, Week 48, n=215, 211 Number Analyzed 215 participants 211 participants
8.257  (33.0405) 3.258  (22.3644)
LDL CHO calculation, NNRTI, Week 24, n=0, 116 Number Analyzed 0 participants 116 participants
6.816  (20.9081)
LDL CHO calculation, NNRTI, Week 48, n=0, 114 Number Analyzed 0 participants 114 participants
4.920  (20.9300)
LDL CHO calculation, INI, Week 24, n=0, 44 Number Analyzed 0 participants 44 participants
6.355  (24.1747)
LDL CHO calculation, INI, Week 48, n=0, 43 Number Analyzed 0 participants 43 participants
3.490  (23.3198)
LDL CHO calculation, PI, Week 24, n=0, 57 Number Analyzed 0 participants 57 participants
4.813  (29.5705)
LDL CHO calculation, PI, Week 48, n=0, 54 Number Analyzed 0 participants 54 participants
-0.434  (24.4332)
Triglycerides, Overall, Week 24, n=228, 223 Number Analyzed 228 participants 223 participants
0.096  (55.6357) 8.649  (48.8249)
Triglycerides, Overall, Week 48, n=221, 218 Number Analyzed 221 participants 218 participants
3.605  (54.4914) 11.068  (54.6321)
Triglycerides, NNRTI, Week 24, n=0, 118 Number Analyzed 0 participants 118 participants
6.867  (44.8605)
Triglycerides, NNRTI, Week 48, n=0, 118 Number Analyzed 0 participants 118 participants
10.215  (58.4055)
Triglycerides, INI, Week 24, n=0, 44 Number Analyzed 0 participants 44 participants
8.386  (54.1265)
Triglycerides, INI, Week 48, n=0, 43 Number Analyzed 0 participants 43 participants
4.644  (48.8708)
Triglycerides, PI, Week 24, n=0, 61 Number Analyzed 0 participants 61 participants
12.283  (52.6943)
Triglycerides, PI, Week 48, n=0, 57 Number Analyzed 0 participants 57 participants
17.681  (50.6912)
32.Secondary Outcome
Title Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48 or Withdrawal From the Study
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. Between and within treatment group comparisons were assessed on change from Baseline in pre-specified treatment symptoms using the Symptom Distress Module at Weeks 4, 24 and 48 or withdrawal from the study. Change from Baseline in Symptom count and symptom bother score have been summarized. The 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). The symptom bother score ranges from 0 to 80. Last observation carried forward (LOCF) was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Symptom count, Week 4, n=212, 197 Number Analyzed 212 participants 197 participants
-1.6  (4.19) 0.2  (4.26)
Symptom count, Week 24, n=214, 201 Number Analyzed 214 participants 201 participants
-0.8  (5.19) -0.2  (4.06)
Symptom count, Week 48, n=214, 201 Number Analyzed 214 participants 201 participants
-0.4  (5.52) 0.0  (4.49)
Symptom Bother Score, Week 4, n=212, 197 Number Analyzed 212 participants 197 participants
-3.0  (7.25) -0.8  (7.82)
Symptom Bother Score, Week 24, n=214, 201 Number Analyzed 214 participants 201 participants
-1.7  (8.47) -1.3  (8.53)
Symptom Bother Score, Week 48, n=214, 201 Number Analyzed 214 participants 201 participants
-1.4  (8.32) -0.7  (9.03)
Show Statistical Analysis 1 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 0.940
Comments P-value for interaction between treatment group and Baseline symptom bother score (Week 4)
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 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 (Week 4)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.924
Confidence Interval (2-Sided) 95%
-4.260 to -1.588
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.
Show Statistical Analysis 3 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 0.001
Comments P-value for interaction between treatment group and Baseline symptom bother score (Week 24)
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 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 0.110
Comments P value to assess difference between treatment groups (Week 24)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.192
Confidence Interval (2-Sided) 95%
-2.656 to 0.271
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.
Show Statistical Analysis 5 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 0.048
Comments P-value for interaction between treatment group and Baseline symptom bother score (Week 48)
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 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 0.038
Comments P value to assess difference between treatment groups (Week 48)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.569
Confidence Interval (2-Sided) 95%
-3.048 to -0.090
Estimation Comments Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.
33.Secondary Outcome
Title Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48 or Withdrawal From the Study
Hide Description The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0-6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Between and within treatment group comparisons were assessed on change from Baseline treatment satisfaction using the HIV TSQ at Weeks 4, 24 and 48 or withdrawal from the study. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Up to 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
Overall Number of Participants Analyzed 252 256
Median (Full Range)
Unit of Measure: Scores on a scale
Total score, Week 4, n=250, 249 Number Analyzed 250 participants 249 participants
0.0
(-16 to 33)
0.0
(-25 to 21)
Total score, Week 24, n=252, 254 Number Analyzed 252 participants 254 participants
1.0
(-18 to 33)
0.0
(-28 to 28)
Total score, Week 48, n=252, 254 Number Analyzed 252 participants 254 participants
0.5
(-24 to 33)
0.0
(-28 to 20)
lifestyle/ease Sub-score, Week 4, n=248, 249 Number Analyzed 248 participants 249 participants
0.0
(-7 to 15)
0.0
(-9 to 13)
lifestyle/ease Sub-score, Week 24, n=252, 254 Number Analyzed 252 participants 254 participants
0.0
(-11 to 15)
0.0
(-14 to 12)
lifestyle/ease Sub-score, Week 48, n=252, 254 Number Analyzed 252 participants 254 participants
0.0
(-13 to 16)
0.0
(-14 to 13)
General Satisfaction/CS, Week 4, n=249, 249 Number Analyzed 249 participants 249 participants
0.0
(-10 to 18)
0.0
(-16 to 13)
General Satisfaction/CS, Week 24, n=252, 254 Number Analyzed 252 participants 254 participants
0.0
(-7 to 18)
0.0
(-14 to 17)
General Satisfaction/CS, Week 48, n=252, 254 Number Analyzed 252 participants 254 participants
0.0
(-14 to 18)
0.0
(-14 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.002
Comments P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 2 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 <0.001
Comments P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 3 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 0.024
Comments P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 4 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 <0.001
Comments P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
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 <0.001
Comments P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 6 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 0.005
Comments P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
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 0.063
Comments P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 8 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 0.002
Comments P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)
Method Wilcoxon rank sum test
Comments [Not Specified]
Show Statistical Analysis 9 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 0.099
Comments P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)
Method Wilcoxon rank sum test
Comments [Not Specified]
Time Frame On-treatment SAEs and non-serious AEs were collected from the start of the study treatment up to 52 weeks (until interim analysis). They are planned to be assessed up to 148 weeks and every 12 weeks after 148 weeks.
Adverse Event Reporting Description On treatment SAEs and non-serious AEs were reported for the 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 their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [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.
All-Cause Mortality
DTG + RPV Current Antiretroviral Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/252 (0.00%)   1/256 (0.39%) 
Show Serious Adverse Events Hide Serious Adverse Events
DTG + RPV Current Antiretroviral Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   9/252 (3.57%)   12/256 (4.69%) 
Ear and labyrinth disorders     
Vertigo  1  1/252 (0.40%)  0/256 (0.00%) 
Gastrointestinal disorders     
Anal fistula  1  0/252 (0.00%)  1/256 (0.39%) 
Pancreatitis acute  1  1/252 (0.40%)  0/256 (0.00%) 
Proctitis  1  0/252 (0.00%)  1/256 (0.39%) 
General disorders     
Non-cardiac chest pain  1  0/252 (0.00%)  1/256 (0.39%) 
Hepatobiliary disorders     
Drug-induced liver injury  1  1/252 (0.40%)  0/256 (0.00%) 
Infections and infestations     
Bronchitis  1  0/252 (0.00%)  1/256 (0.39%) 
Gastroenteritis  1  1/252 (0.40%)  0/256 (0.00%) 
Hepatitis C  1  0/252 (0.00%)  1/256 (0.39%) 
Influenza  1  0/252 (0.00%)  1/256 (0.39%) 
Peritonsillar abscess  1  0/252 (0.00%)  1/256 (0.39%) 
Pneumonia  1  1/252 (0.40%)  0/256 (0.00%) 
Rectal abscess  1  0/252 (0.00%)  1/256 (0.39%) 
Thyroglossal cyst infection  1  0/252 (0.00%)  1/256 (0.39%) 
Injury, poisoning and procedural complications     
Wrist fracture  1  1/252 (0.40%)  0/256 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/252 (0.00%)  1/256 (0.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/252 (0.00%)  1/256 (0.39%) 
Hodgkin's disease mixed cellularity stage unspecified  1  1/252 (0.40%)  0/256 (0.00%) 
Lung neoplasm malignant  1  0/252 (0.00%)  1/256 (0.39%) 
Plasmablastic lymphoma  1  1/252 (0.40%)  0/256 (0.00%) 
Nervous system disorders     
Toxic encephalopathy  1  0/252 (0.00%)  1/256 (0.39%) 
Psychiatric disorders     
Panic attack  1  1/252 (0.40%)  0/256 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DTG + RPV Current Antiretroviral Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   65/252 (25.79%)   68/256 (26.56%) 
Gastrointestinal disorders     
Diarrhoea  1  21/252 (8.33%)  16/256 (6.25%) 
Infections and infestations     
Nasopharyngitis  1  28/252 (11.11%)  28/256 (10.94%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  9/252 (3.57%)  19/256 (7.42%) 
Nervous system disorders     
Headache  1  23/252 (9.13%)  17/256 (6.64%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir plus rilpivirine for the maintenance of virologic suppression in HIV-1-infected adults: the phase III, randomized, open-label, active-controlled, noninferiority SWORD-1 and SWORD-2 studies. Lancet [epublished ahead of print] 6 January 2018.
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02429791     History of Changes
Other Study ID Numbers: 201636
2014-005147-40 ( EudraCT Number )
First Submitted: April 9, 2015
First Posted: April 29, 2015
Results First Submitted: July 27, 2017
Results First Posted: December 2, 2017
Last Update Posted: July 30, 2019