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

• ClinicalTrials.gov Identifier: NCT02422797
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2015
• Results First Posted: October 24, 2017
• Last Update Posted: December 14, 2021
• Sponsor: ViiV Healthcare
• Collaborators: Janssen Pharmaceuticals; GlaxoSmithKline
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infections
• Interventions: Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: CAR
• Enrollment: 518

Participant Flow

Recruitment Details	This study was a 148-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study to assess the antiviral activity and safety of a two-drug regimen of dolutegravir (DTG) + rilpivirine (RPV) compared with current antiretroviral regimen (CAR). The study was conducted at 60 centers in 11 countries.
Pre-assignment Details	Total 639 participants were screened (121 failed), 518 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included a Screening phase, an early switch phase, a late switch phase, and a continuation phase. The results presented are based on the interim analysis of the Late Switch Phase (Week 148).

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Period Title: Early Switch Phase (Up to Week 52)
Started	261	255
Completed	245	239
Not Completed	16	16
Reason Not Completed
Adverse Event	11	1
Physician Decision	0	1
Lack of Efficacy	1	2
Lost to Follow-up	1	1
Protocol Violation	0	3
Reached stopping criteria	1	1
Withdrawal by Subject	2	7
Period Title: Late Switch Phase (Week 52 to Week 148)
Started	245	239
Completed	222	221
Not Completed	23	18
Reason Not Completed
Physician Decision	0	1
Adverse Event	10	6
Lack of Efficacy	5	3
Lost to Follow-up	2	2
Withdrawal by Subject	2	6
Reached stopping criteria	1	0
Protocol Violation	3	0

Baseline Characteristics

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen	Total
Arm/Group Description		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.	Total of all reporting groups
Overall Number of Baseline Participants		261	255	516
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	261 participants	255 participants	516 participants
		43.3 (11.34)	43.2 (9.64)	43.3 (10.52)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	261 participants	255 participants	516 participants
	Female	62 23.8%	57 22.4%	119 23.1%
	Male	199 76.2%	198 77.6%	397 76.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	261 participants	255 participants	516 participants
American Indian or Alaska Native		11 4.2%	7 2.7%	18 3.5%
Central/South Asian Heritage		0 0.0%	1 0.4%	1 0.2%
Japanese/East Asian (EA) Heritage (H.)/South EA H.		13 5.0%	15 5.9%	28 5.4%
Black/African American		13 5.0%	19 7.5%	32 6.2%
Native Hawaiian or other Pacific Islander		1 0.4%	0 0.0%	1 0.2%
White		223 85.4%	212 83.1%	435 84.3%
African American/ African H. and White		0 0.0%	1 0.4%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
Description	Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	261	255
Measure Type: Number; Unit of Measure: Percentage of participants
	94	94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -10%.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -3.9 to 4.2
	Estimation Comments	Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INSTI).

2. Secondary Outcome

Title	Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1), Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Cells per millimeter cube (mm^3)
Week 24, n=251, 250	Number Analyzed	251 participants	250 participants
		42.0 (172.29)	42.4 (164.85)
Week 48, n=245, 241	Number Analyzed	245 participants	241 participants
		28.0 (169.35)	18.4 (159.34)

3. Secondary Outcome

Title	Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
Description	Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	261	255
Measure Type: Number; Unit of Measure: Percentage of participants
	97	98

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -4.0 to 1.8
	Estimation Comments	Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.

4. Secondary Outcome

Title	Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Description	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with >5% incidence for either treatment. This summary presents results as reported after all participants completed the Early Switch Phase.
Time Frame	Up to Week 52

Outcome Measure Data

Analysis Population Description

Safety Population included all randomized participants who received at least one dose of study drug.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	261	255
Measure Type: Count of Participants; Unit of Measure: Participants
Common non-serious AE	61 23.4%	59 23.1%
Any SAE	18 6.9%	9 3.5%
Maximum toxicity Grade 1 AE	119 45.6%	122 47.8%
Maximum toxicity Grade 2 AE	59 22.6%	47 18.4%
Maximum toxicity Grade 3 AE	16 6.1%	4 1.6%
Maximum toxicity Grade 4 AE	1 0.4%	1 0.4%
AELD	12 4.6%	1 0.4%

5. Secondary Outcome

Title	Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Description	Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	261	255
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	92 35.2%	80 31.4%
Grade 2	72 27.6%	79 31.0%
Grade 3	11 4.2%	16 6.3%
Grade 4	1 0.4%	10 3.9%

6. Secondary Outcome

Title	Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Description	Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	261	255
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	11 4.2%	11 4.3%
Grade 2	2 0.8%	2 0.8%
Grade 3	3 1.1%	0 0.0%
Grade 4	1 0.4%	0 0.0%

7. Secondary Outcome

Title	Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	246	239
Mean (Standard Deviation); Unit of Measure: mg/Liter (L)
	0.10 (5.383)	0.80 (8.527)

8. Secondary Outcome

Title	Mean Change From Baseline in Cystatin C at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	246	237
Mean (Standard Deviation); Unit of Measure: mg/L
	-0.02 (0.110)	-0.01 (0.108)

9. Secondary Outcome

Title	Mean Change From Baseline in D-Dimer at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	239	228
Mean (Standard Deviation); Unit of Measure: Nanomole/L fibrinogen equivalent units
	0.01 (1.629)	-0.13 (2.932)

10. Secondary Outcome

Title	Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Nanogram/milliliter
FABP, n=245, 236	Number Analyzed	245 participants	236 participants
		-1.50 (1.278)	-0.99 (1.441)
Soluble CD14, n=245, 237	Number Analyzed	245 participants	237 participants
		456.69 (731.833)	802.26 (878.304)

11. Secondary Outcome

Title	Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Microgram/Liter
Soluble CD163, n=245, 236	Number Analyzed	245 participants	236 participants
		65.38 (180.869)	53.94 (215.621)
Oxidized LDL, n=245, 237	Number Analyzed	245 participants	237 participants
		60.87 (504.345)	13.92 (575.305)

12. Secondary Outcome

Title	Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: mg/deciliter (dL)
RBP, n=245, 237	Number Analyzed	245 participants	237 participants
		-0.13 (0.825)	0.00 (0.872)
Serum creatinine, n=245, 241	Number Analyzed	245 participants	241 participants
		0.100 (0.1053)	-0.003 (0.0847)
Glucose, n=242, 235	Number Analyzed	242 participants	235 participants
		0.187 (19.5808)	3.220 (10.0987)

13. Secondary Outcome

Title	Mean Change From Baseline in Urine Phosphate at Week 48
Description	Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	235	229
Mean (Standard Deviation); Unit of Measure: Millimoles (mmol)/L
	1.335 (16.7211)	-0.798 (15.3771)

14. Secondary Outcome

Title	Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Nanomoles (nmol)/L
B2M, blood, n=245, 238	Number Analyzed	245 participants	238 participants
		-16.8800 (34.89330)	-4.7501 (43.04355)
25 hydroxy-vitamin D, blood, n=243, 239	Number Analyzed	243 participants	239 participants
		-13.9 (25.30)	-9.2 (19.55)
Urine B2M, n=72, 78	Number Analyzed	72 participants	78 participants
		-173.2820 (1311.24142)	62.3209 (391.32049)
Urine RBP, n=232, 224	Number Analyzed	232 participants	224 participants
		-6.8123 (24.09650)	-0.0631 (11.99886)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.011
	Comments	P value to assess difference between treatment groups (25 hydroxy-vitamin D - INSTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.861
	Confidence Interval	(2-Sided) 95%; 0.767 to 0.967
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.745
	Comments	P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.012
	Confidence Interval	(2-Sided) 95%; 0.943 to 1.085
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.018
	Comments	P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.877
	Confidence Interval	(2-Sided) 95%; 0.787 to 0.977
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

15. Secondary Outcome

Title	Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Description	Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Grams (g)/mol
Urine albumin/creatinine ratio, n=178, 181	Number Analyzed	178 participants	181 participants
		-0.78 (5.116)	-0.64 (9.538)
Urine protein/creatinine ratio, n=192, 193	Number Analyzed	192 participants	193 participants
		-2.73 (12.683)	1.23 (5.088)

16. Secondary Outcome

Title	Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Microgram (ug)/L
Bone-specific alkaline phosphatase, n=246, 236	Number Analyzed	246 participants	236 participants
		-3.18 (5.678)	0.92 (4.634)
Procollagen type 1 N-propeptide, n=245, 237	Number Analyzed	245 participants	237 participants
		-5.8 (20.00)	0.3 (19.28)
Osteocalcin, n=245, 235	Number Analyzed	245 participants	235 participants
		-5.11 (7.334)	-1.14 (6.017)
Type I Collagen C-Telopeptides, n=243, 238	Number Analyzed	243 participants	238 participants
		-0.15 (0.313)	-0.09 (0.344)
sVCAM, n=245, 237	Number Analyzed	245 participants	237 participants
		-2.63 (571.182)	37.42 (617.486)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.728
	Confidence Interval	(2-Sided) 95%; 0.686 to 0.773
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INSTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.865
	Confidence Interval	(2-Sided) 95%; 0.785 to 0.954
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.788
	Confidence Interval	(2-Sided) 95%; 0.719 to 0.864
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.677
	Comments	P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (procollagen type 1-N-propeptide)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.867
	Confidence Interval	(2-Sided) 95%; 0.823 to 0.914
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P-value for interaction between treatment group and Baseline third agent (osteocalcin)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (osteocalcin - NNRTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.853
	Confidence Interval	(2-Sided) 95%; 0.799 to 0.910
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.028
	Comments	P value to assess difference between treatment groups (osteocalcin - INSTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.886
	Confidence Interval	(2-Sided) 95%; 0.796 to 0.987
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (osteocalcin - PI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.743
	Confidence Interval	(2-Sided) 95%; 0.672 to 0.822
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.782
	Comments	P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.818
	Confidence Interval	(2-Sided) 95%; 0.751 to 0.891
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

17. Secondary Outcome

Title	Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	245	237
Mean (Standard Deviation); Unit of Measure: Nanograms (ng)/L
	-0.08 (2.373)	-0.07 (2.761)

18. Secondary Outcome

Title	Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	237	224
Mean (Standard Deviation); Unit of Measure: HOMA-IR Score
	0.50 (4.780)	0.80 (3.938)

19. Secondary Outcome

Title	Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Description	Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1), Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Millimoles (mmol)/L
Total cholesterol, Week 24, n=237, 229	Number Analyzed	237 participants	229 participants
		-0.015 (0.7539)	0.020 (0.5777)
Total cholesterol, Week 48, n=237, 230	Number Analyzed	237 participants	230 participants
		-0.079 (0.7926)	-0.038 (0.6148)
LDL cholesterol calculation, Week 24, n=231, 221	Number Analyzed	231 participants	221 participants
		0.085 (0.5940)	0.055 (0.5232)
LDL cholesterol calculation, Week 48, n=229, 220	Number Analyzed	229 participants	220 participants
		-0.049 (0.6276)	-0.076 (0.5280)
HDL cholesterol direct, Week 24, n=237, 229	Number Analyzed	237 participants	229 participants
		-0.024 (0.2365)	-0.051 (0.2258)
HDL cholesterol direct, Week 48, n=237, 230	Number Analyzed	237 participants	230 participants
		0.051 (0.2386)	0.049 (0.2489)
Triglycerides, Week 24, n=237, 229	Number Analyzed	237 participants	229 participants
		-0.184 (1.0102)	0.040 (0.9164)
Triglycerides, Week 48, n=237, 230	Number Analyzed	237 participants	230 participants
		-0.169 (1.0062)	-0.021 (1.0156)

20. Secondary Outcome

Title	Number of Participants With Genotypic Resistance-Early Switch Phase
Description	Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine [RPV], Dolutegravir [DTG]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented. CVW resistance Population comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

CVW resistance Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	1	0
Measure Type: Count of Participants; Unit of Measure: Participants
INSTI, DTG, Susceptible	1 100.0%
INSTI, DTG, Potential low-level resistance	0 0.0%
INSTI, DTG, Low-level resistance	0 0.0%
INSTI, DTG, Intermediate resistance	0 0.0%
INSTI, DTG, High-level resistance	0 0.0%
NNRTI, RPV, Susceptible	0 0.0%
NNRTI, RPV, Potential low-level resistance	0 0.0%
NNRTI, RPV, Low-level resistance	0 0.0%
NNRTI, RPV, Intermediate resistance	1 100.0%
NNRTI, RPV, High-level resistance	0 0.0%

21. Secondary Outcome

Title	Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Arm Through Early and Late Switch Phase
Description	Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir [EVG], Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine [NVP], RPV, Lamivudine [3TC], Abacavir [ABC], FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/r [ATV/r], DRV/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]) in participants Meeting Confirmed Virologic Withdrawal Criteria has been presented.
Time Frame	Up to Week 148

Outcome Measure Data

Analysis Population Description

CVW resistance Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Overall Number of Participants Analyzed	2
Measure Type: Count of Participants; Unit of Measure: Participants
INI, DTG, Susceptible	2 100.0%
INI, DTG, Potential low-level resistance	0 0.0%
INI, DTG, Low-level resistance	0 0.0%
INI, DTG, Intermediate resistance	0 0.0%
INI, DTG, High-level resistance	0 0.0%
INI, EVG, Susceptible	2 100.0%
INI, EVG, Potential low-level resistance	0 0.0%
INI, EVG, Low-level resistance	0 0.0%
INI, EVG, Intermediate resistance	0 0.0%
INI, EVG, High-level resistance	0 0.0%
INI, RAL, Susceptible	2 100.0%
INI, RAL, Potential low-level resistance	0 0.0%
INI, RAL, Low-level resistance	0 0.0%
INI, RAL, Intermediate resistance	0 0.0%
INI, RAL, High-level resistance	0 0.0%
NNRTI, DLV, Susceptible	2 100.0%
NNRTI, DLV, Potential low-level resistance	0 0.0%
NNRTI, DLV, Low-level resistance	0 0.0%
NNRTI, DLV, Intermediate resistance	0 0.0%
NNRTI, DLV, High-level resistance	0 0.0%
NNRTI, EFV, Susceptible	0 0.0%
NNRTI, EFV, Potential low-level resistance	0 0.0%
NNRTI, EFV, Low-level resistance	1 50.0%
NNRTI, EFV, Intermediate resistance	0 0.0%
NNRTI, EFV, High-level resistance	1 50.0%
NNRTI, ETR, Susceptible	0 0.0%
NNRTI, ETR, Potential low-level resistance	0 0.0%
NNRTI, ETR, Low-level resistance	1 50.0%
NNRTI, ETR, Intermediate resistance	0 0.0%
NNRTI, ETR, High-level resistance	1 50.0%
NNRTI, NVP, Susceptible	0 0.0%
NNRTI, NVP, Potential low-level resistance	0 0.0%
NNRTI, NVP, Low-level resistance	0 0.0%
NNRTI, NVP, Intermediate resistance	1 50.0%
NNRTI, NVP, High-level resistance	1 50.0%
NNRTI, RPV, Susceptible	0 0.0%
NNRTI, RPV, Potential low-level resistance	0 0.0%
NNRTI, RPV, Low-level resistance	0 0.0%
NNRTI, RPV, Intermediate resistance	1 50.0%
NNRTI, RPV, High-level resistance	1 50.0%
NRTI, 3TC, Susceptible	2 100.0%
NRTI, 3TC, Potential low-level resistance	0 0.0%
NRTI, 3TC, Low-level resistance	0 0.0%
NRTI, 3TC, Intermediate resistance	0 0.0%
NRTI, 3TC, High-level resistance	0 0.0%
NRTI, ABC, Susceptible	2 100.0%
NRTI, ABC, Potential low-level resistance	0 0.0%
NRTI, ABC, Low-level resistance	0 0.0%
NRTI, ABC, Intermediate resistance	0 0.0%
NRTI, ABC, High-level resistance	0 0.0%
NRTI, FTC, Susceptible	2 100.0%
NRTI, FTC, Potential low-level resistance	0 0.0%
NRTI, FTC, Low-level resistance	0 0.0%
NRTI, FTC, Intermediate resistance	0 0.0%
NRTI, FTC, High-level resistance	0 0.0%
NRTI, TDF, Susceptible	2 100.0%
NRTI, TDF, Potential low-level resistance	0 0.0%
NRTI, TDF, Low-level resistance	0 0.0%
NRTI, TDF, Intermediate resistance	0 0.0%
NRTI, TDF, High-level resistance	0 0.0%
NRTI, ZDV, Susceptible	2 100.0%
NRTI, ZDV, Potential low-level resistance	0 0.0%
NRTI, ZDV, Low-level resistance	0 0.0%
NRTI, ZDV, Intermediate resistance	0 0.0%
NRTI, ZDV, High-level resistance	0 0.0%
NRTI, d4T, Susceptible	2 100.0%
NRTI, d4T, Potential low-level resistance	0 0.0%
NRTI, d4T, Low-level resistance	0 0.0%
NRTI, d4T, Intermediate resistance	0 0.0%
NRTI, d4T, High-level resistance	0 0.0%
NRTI, ddI, Susceptible	2 100.0%
NRTI, ddI, Potential low-level resistance	0 0.0%
NRTI, ddI, Low-level resistance	0 0.0%
NRTI, ddI, Intermediate resistance	0 0.0%
NRTI, ddI, High-level resistance	0 0.0%
PI, ATV/r, Susceptible	2 100.0%
PI, ATV/r, Potential low-level resistance	0 0.0%
PI, ATV/r, Low-level resistance	0 0.0%
PI, ATV/r, Intermediate resistance	0 0.0%
PI, ATV/r, High-level resistance	0 0.0%
PI, DRV/r, Susceptible	2 100.0%
PI, DRV/r, Potential low-level resistance	0 0.0%
PI, DRV/r, Low-level resistance	0 0.0%
PI, DRV/r, Intermediate resistance	0 0.0%
PI, DRV/r, High-level resistance	0 0.0%
PI, FPV/r, Susceptible	2 100.0%
PI, FPV/r, Potential low-level resistance	0 0.0%
PI, FPV/r, Low-level resistance	0 0.0%
PI, FPV/r, Intermediate resistance	0 0.0%
PI, FPV/r, High-level resistance	0 0.0%
PI, IDV/r, Susceptible	2 100.0%
PI, IDV/r, Potential low-level resistance	0 0.0%
PI, IDV/r, Low-level resistance	0 0.0%
PI, IDV/r, Intermediate resistance	0 0.0%
PI, IDV/r, High-level resistance	0 0.0%
PI, LPV/r, Susceptible	2 100.0%
PI, LPV/r, Potential low-level resistance	0 0.0%
PI, LPV/r, Low-level resistance	0 0.0%
PI, LPV/r, Intermediate resistance	0 0.0%
PI, LPV/r, High-level resistance	0 0.0%
PI, NFV, Susceptible	2 100.0%
PI, NFV, Potential low-level resistance	0 0.0%
PI, NFV, Low-level resistance	0 0.0%
PI, NFV, Intermediate resistance	0 0.0%
PI, NFV, High-level resistance	0 0.0%
PI, RTV, Susceptible	2 100.0%
PI, RTV, Potential low-level resistance	0 0.0%
PI, RTV, Low-level resistance	0 0.0%
PI, RTV, Intermediate resistance	0 0.0%
PI, RTV, High-level resistance	0 0.0%
PI, SQV/r, Susceptible	2 100.0%
PI, SQV/r, Potential low-level resistance	0 0.0%
PI, SQV/r, Low-level resistance	0 0.0%
PI, SQV/r, Intermediate resistance	0 0.0%
PI, SQV/r, High-level resistance	0 0.0%
PI, TPV/r, Susceptible	2 100.0%
PI, TPV/r, Potential low-level resistance	0 0.0%
PI, TPV/r, Low-level resistance	0 0.0%
PI, TPV/r, Intermediate resistance	0 0.0%
PI, TPV/r, High-level resistance	0 0.0%

22. Secondary Outcome

Title	Number of Participants With Genotypic Resistance-CAR Late Switch Arm Through Late Switch Phase
Description	Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented. Late Switch (LS) CVW resistance Population comprised of all participants in the LS ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion is met.
Time Frame	Post-LS Baseline (Week 52) up to Week 148

Outcome Measure Data

Analysis Population Description

LS CVW resistance Population

Arm/Group Title	Current Antiretroviral Regimen
Arm/Group Description:	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	1
Measure Type: Count of Participants; Unit of Measure: Participants
INI, DTG, Susceptible	1 100.0%
INI, DTG, Potential low-level resistance	0 0.0%
INI, DTG, Low-level resistance	0 0.0%
INI, DTG, Intermediate resistance	0 0.0%
INI, DTG, High-level resistance	0 0.0%
INI, EVG, Susceptible	1 100.0%
INI, EVG, Potential low-level resistance	0 0.0%
INI, EVG, Low-level resistance	0 0.0%
INI, EVG, Intermediate resistance	0 0.0%
INI, EVG, High-level resistance	0 0.0%
INI, RAL, Susceptible	1 100.0%
INI, RAL, Potential low-level resistance	0 0.0%
INI, RAL, Low-level resistance	0 0.0%
INI, RAL, Intermediate resistance	0 0.0%
INI, RAL, High-level resistance	0 0.0%
NNRTI, DLV, Susceptible	1 100.0%
NNRTI, DLV, Potential low-level resistance	0 0.0%
NNRTI, DLV, Low-level resistance	0 0.0%
NNRTI, DLV, Intermediate resistance	0 0.0%
NNRTI, DLV, High-level resistance	0 0.0%
NNRTI, EFV, Susceptible	0 0.0%
NNRTI, EFV, Potential low-level resistance	0 0.0%
NNRTI, EFV, Low-level resistance	0 0.0%
NNRTI, EFV, Intermediate resistance	0 0.0%
NNRTI, EFV, High-level resistance	1 100.0%
NNRTI, ETR, Susceptible	0 0.0%
NNRTI, ETR, Potential low-level resistance	0 0.0%
NNRTI, ETR, Low-level resistance	0 0.0%
NNRTI, ETR, Intermediate resistance	1 100.0%
NNRTI, ETR, High-level resistance	0 0.0%
NNRTI, NVP, Susceptible	0 0.0%
NNRTI, NVP, Potential low-level resistance	0 0.0%
NNRTI, NVP, Low-level resistance	0 0.0%
NNRTI, NVP, Intermediate resistance	0 0.0%
NNRTI, NVP, High-level resistance	1 100.0%
NNRTI, RPV, Susceptible	0 0.0%
NNRTI, RPV, Potential low-level resistance	0 0.0%
NNRTI, RPV, Low-level resistance	0 0.0%
NNRTI, RPV, Intermediate resistance	0 0.0%
NNRTI, RPV, High-level resistance	1 100.0%
NRTI, 3TC, Susceptible	1 100.0%
NRTI, 3TC, Potential low-level resistance	0 0.0%
NRTI, 3TC, Low-level resistance	0 0.0%
NRTI, 3TC, Intermediate resistance	0 0.0%
NRTI, 3TC, High-level resistance	0 0.0%
NRTI, ABC, Susceptible	1 100.0%
NRTI, ABC, Potential low-level resistance	0 0.0%
NRTI, ABC, Low-level resistance	0 0.0%
NRTI, ABC, Intermediate resistance	0 0.0%
NRTI, ABC, High-level resistance	0 0.0%
NRTI, FTC, Susceptible	1 100.0%
NRTI, FTC, Potential low-level resistance	0 0.0%
NRTI, FTC, Low-level resistance	0 0.0%
NRTI, FTC, Intermediate resistance	0 0.0%
NRTI, FTC, High-level resistance	0 0.0%
NRTI, TDF, Susceptible	1 100.0%
NRTI, TDF, Potential low-level resistance	0 0.0%
NRTI, TDF, Low-level resistance	0 0.0%
NRTI, TDF, Intermediate resistance	0 0.0%
NRTI, TDF, High-level resistance	0 0.0%
NRTI, ZDV, Susceptible	1 100.0%
NRTI, ZDV, Potential low-level resistance	0 0.0%
NRTI, ZDV, Low-level resistance	0 0.0%
NRTI, ZDV, Intermediate resistance	0 0.0%
NRTI, ZDV, High-level resistance	0 0.0%
NRTI, d4T, Susceptible	1 100.0%
NRTI, d4T, Potential low-level resistance	0 0.0%
NRTI, d4T, Low-level resistance	0 0.0%
NRTI, d4T, Intermediate resistance	0 0.0%
NRTI, d4T, High-level resistance	0 0.0%
NRTI, ddI, Susceptible	1 100.0%
NRTI, ddI, Potential low-level resistance	0 0.0%
NRTI, ddI, Low-level resistance	0 0.0%
NRTI, ddI, Intermediate resistance	0 0.0%
NRTI, ddI, High-level resistance	0 0.0%
PI, ATV/r, Susceptible	1 100.0%
PI, ATV/r, Potential low-level resistance	0 0.0%
PI, ATV/r, Low-level resistance	0 0.0%
PI, ATV/r, Intermediate resistance	0 0.0%
PI, ATV/r, High-level resistance	0 0.0%
PI, DRV/r, Susceptible	1 100.0%
PI, DRV/r, Potential low-level resistance	0 0.0%
PI, DRV/r, Low-level resistance	0 0.0%
PI, DRV/r, Intermediate resistance	0 0.0%
PI, DRV/r, High-level resistance	0 0.0%
PI, FPV/r, Susceptible	1 100.0%
PI, FPV/r, Potential low-level resistance	0 0.0%
PI, FPV/r, Low-level resistance	0 0.0%
PI, FPV/r, Intermediate resistance	0 0.0%
PI, FPV/r, High-level resistance	0 0.0%
PI, IDV/r, Susceptible	1 100.0%
PI, IDV/r, Potential low-level resistance	0 0.0%
PI, IDV/r, Low-level resistance	0 0.0%
PI, IDV/r, Intermediate resistance	0 0.0%
PI, IDV/r, High-level resistance	0 0.0%
PI, LPV/r, Susceptible	1 100.0%
PI, LPV/r, Potential low-level resistance	0 0.0%
PI, LPV/r, Low-level resistance	0 0.0%
PI, LPV/r, Intermediate resistance	0 0.0%
PI, LPV/r, High-level resistance	0 0.0%
PI, NFV, Susceptible	1 100.0%
PI, NFV, Potential low-level resistance	0 0.0%
PI, NFV, Low-level resistance	0 0.0%
PI, NFV, Intermediate resistance	0 0.0%
PI, NFV, High-level resistance	0 0.0%
PI, RTV, Susceptible	1 100.0%
PI, RTV, Potential low-level resistance	0 0.0%
PI, RTV, Low-level resistance	0 0.0%
PI, RTV, Intermediate resistance	0 0.0%
PI, RTV, High-level resistance	0 0.0%
PI, SQV/r, Susceptible	1 100.0%
PI, SQV/r, Potential low-level resistance	0 0.0%
PI, SQV/r, Low-level resistance	0 0.0%
PI, SQV/r, Intermediate resistance	0 0.0%
PI, SQV/r, High-level resistance	0 0.0%
PI, TPV/r, Susceptible	1 100.0%
PI, TPV/r, Potential low-level resistance	0 0.0%
PI, TPV/r, Low-level resistance	0 0.0%
PI, TPV/r, Intermediate resistance	0 0.0%
PI, TPV/r, High-level resistance	0 0.0%

23. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance-Early Switch Phase
Description	Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

CVW resistance Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	1	0
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI, RPV, Resistant	0 0.0%
NNRTI, RPV, Sensitive	1 100.0%
NNRTI, ETR, Resistant	0 0.0%
NNRTI, ETR, Partially Sensitive	0 0.0%
NNRTI, ETR, Sensitive	1 100.0%
NNRTI, DLV, Resistant	0 0.0%
NNRTI, DLV, Sensitive	1 100.0%
NNRTI, EFV, Resistant	0 0.0%
NNRTI, EFV, Sensitive	1 100.0%
NNRTI, NVP, Resistant	0 0.0%
NNRTI, NVP, Sensitive	1 100.0%
NRTI, 3TC, Resistant	0 0.0%
NRTI, 3TC, Sensitive	1 100.0%
NRTI, ABC, Resistant	0 0.0%
NRTI, ABC, Partially Sensitive	0 0.0%
NRTI, ABC, Sensitive	1 100.0%
NRTI, TDF, Resistant	0 0.0%
NRTI, TDF, Partially Sensitive	0 0.0%
NRTI, TDF, Sensitive	1 100.0%
NRTI, d4T, Resistant	0 0.0%
NRTI, d4T, Sensitive	1 100.0%
NRTI, ddI, Resistant	0 0.0%
NRTI, ddI, Partially Sensitive	0 0.0%
NRTI, ddI, Sensitive	1 100.0%
NRTI, FTC, Resistant	0 0.0%
NRTI, FTC, Sensitive	1 100.0%
NRTI, ZDV, Resistant	0 0.0%
NRTI, ZDV, Sensitive	1 100.0%
PI, ATV/r, Resistant	0 0.0%
PI, ATV/r, Sensitive	1 100.0%
PI, DRV/r, Resistant	0 0.0%
PI, DRV/r, Partially Sensitive	0 0.0%
PI, DRV/r, Sensitive	1 100.0%
PI, FPV/r, Resistant	0 0.0%
PI, FPV/r, Partially Sensitive	0 0.0%
PI, FPV/r, Sensitive	1 100.0%
PI, IDV/r, Resistant	0 0.0%
PI, IDV/r, Sensitive	1 100.0%
PI, LPV/r, Resistant	0 0.0%
PI, LPV/r, Partially Sensitive	0 0.0%
PI, LPV/r, Sensitive	1 100.0%
PI, SQV/r, Resistant	0 0.0%
PI, SQV/r, Partially Sensitive	0 0.0%
PI, SQV/r, Sensitive	1 100.0%
PI, TPV/r, Resistant	0 0.0%
PI, TPV/r, Partially Sensitive	0 0.0%
PI, TPV/r, Sensitive	1 100.0%
PI, NFV, Resistant	0 0.0%
PI, NFV, Sensitive	1 100.0%
PI, RTV, Resistant	0 0.0%
PI, RTV, Sensitive	1 100.0%

24. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time Frame	Up to Week 148

Outcome Measure Data

Analysis Population Description

CVW resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		DTG + RPV
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Overall Number of Participants Analyzed		2
Measure Type: Count of Participants; Unit of Measure: Participants
INI, DTG, Resistant, n=1	Number Analyzed	1 participants
		0 0.0%
INI, DTG, Partially Sensitive, n=1	Number Analyzed	1 participants
		0 0.0%
INI, DTG, Sensitive, n=1	Number Analyzed	1 participants
		1 100.0%
INI, EVG, Resistant, n=1	Number Analyzed	1 participants
		0 0.0%
INI, EVG, Partially sensitive, n=1	Number Analyzed	1 participants
		0 0.0%
INI, EVG, Sensitive, n=1	Number Analyzed	1 participants
		1 100.0%
INI, RAL, Resistant, n=1	Number Analyzed	1 participants
		1 100.0%
INI, RAL, Partially sensitive, n=1	Number Analyzed	1 participants
		0 0.0%
INI, RAL, Sensitive, n=1	Number Analyzed	1 participants
		0 0.0%
NNRTI, DLV, Resistant, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, DLV, Partially Sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NNRTI, DLV, Sensitive, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, EFV, Resistant, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, EFV, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NNRTI, EFV, Sensitive, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, ETR, Resistant, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, ETR, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NNRTI, ETR, Sensitive, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, NVP, Resistant, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, NVP, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NNRTI, NVP, Sensitive, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, RPV, Resistant, n=2	Number Analyzed	2 participants
		1 50.0%
NNRTI, RPV, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NNRTI, RPV, Sensitive, n=2	Number Analyzed	2 participants
		1 50.0%
NRTI, 3TC, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, 3TC, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, 3TC, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
NRTI, ABC, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, ABC, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, ABC, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
NRTI, FTC, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, FTC, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, FTC, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
NRTI, TDF, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, TDF, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, TDF, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
NRTI, ZDV, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, ZDV, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, ZDV, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
NRTI, d4T, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, d4T, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, d4T, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
NRTI, ddI, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, ddI, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
NRTI, ddI, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, ATV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, ATV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, ATV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, DRV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, DRV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, DRV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, FPV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, FPV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, FPV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, IDV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, IDV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, IDV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, LPV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, LPV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, LPV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, NFV, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, NFV, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, NFV, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, RTV, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, RTV, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, RTV, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, SQV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, SQV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, SQV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%
PI, TPV/r, Resistant, n=2	Number Analyzed	2 participants
		0 0.0%
PI, TPV/r, Partially sensitive, n=2	Number Analyzed	2 participants
		0 0.0%
PI, TPV/r, Sensitive, n=2	Number Analyzed	2 participants
		2 100.0%

25. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance-CAR Late Switch Group Through Late Switch Phase
Description	Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time Frame	Post-LS Baseline (Week 52) up to Week 148

Outcome Measure Data

Analysis Population Description

LS CVW resistance Population

Arm/Group Title	Current Antiretroviral Regimen
Arm/Group Description:	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	1
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI, DLV, Resistant	1 100.0%
NNRTI, DLV, Partially Sensitive	0 0.0%
NNRTI, DLV, Sensitive	0 0.0%
NNRTI, EFV, Resistant	1 100.0%
NNRTI, EFV, Partially sensitive	0 0.0%
NNRTI, EFV, Sensitive	0 0.0%
NNRTI, ETR, Resistant	0 0.0%
NNRTI, ETR, Partially sensitive	1 100.0%
NNRTI, ETR, Sensitive	0 0.0%
NNRTI, NVP, Resistant	1 100.0%
NNRTI, NVP, Partially sensitive	0 0.0%
NNRTI, NVP, Sensitive	0 0.0%
NNRTI, RPV, Resistant	1 100.0%
NNRTI, RPV, Partially sensitive	0 0.0%
NNRTI, RPV, Sensitive	0 0.0%
NRTI, 3TC, Resistant	0 0.0%
NRTI, 3TC, Partially sensitive	0 0.0%
NRTI, 3TC, Sensitive	1 100.0%
NRTI, ABC, Resistant	0 0.0%
NRTI, ABC, Partially sensitive	0 0.0%
NRTI, ABC, Sensitive	1 100.0%
NRTI, FTC, Resistant	0 0.0%
NRTI, FTC, Partially sensitive	0 0.0%
NRTI, FTC, Sensitive	1 100.0%
NRTI, TDF, Resistant	0 0.0%
NRTI, TDF, Partially sensitive	0 0.0%
NRTI, TDF, Sensitive	1 100.0%
NRTI, ZDV, Resistant	0 0.0%
NRTI, ZDV, Partially sensitive	0 0.0%
NRTI, ZDV, Sensitive	1 100.0%
NRTI, d4T, Resistant	0 0.0%
NRTI, d4T, Partially sensitive	0 0.0%
NRTI, d4T, Sensitive	1 100.0%
NRTI, ddI, Resistant	0 0.0%
NRTI, ddI, Partially sensitive	0 0.0%
NRTI, ddI, Sensitive	1 100.0%
PI, ATV/r, Resistant	0 0.0%
PI, ATV/r, Partially sensitive	0 0.0%
PI, ATV/r, Sensitive	1 100.0%
PI, DRV/r, Resistant	0 0.0%
PI, DRV/r, Partially sensitive	0 0.0%
PI, DRV/r, Sensitive	1 100.0%
PI, FPV/r, Resistant	0 0.0%
PI, FPV/r, Partially sensitive	0 0.0%
PI, FPV/r, Sensitive	1 100.0%
PI, IDV/r, Resistant	0 0.0%
PI, IDV/r, Partially sensitive	0 0.0%
PI, IDV/r, Sensitive	1 100.0%
PI, LPV/r, Resistant	0 0.0%
PI, LPV/r, Partially sensitive	0 0.0%
PI, LPV/r, Sensitive	1 100.0%
PI, NFV, Resistant	0 0.0%
PI, NFV, Partially sensitive	0 0.0%
PI, NFV, Sensitive	1 100.0%
PI, RTV, Resistant	0 0.0%
PI, RTV, Partially sensitive	0 0.0%
PI, RTV, Sensitive	1 100.0%
PI, SQV/r, Resistant	0 0.0%
PI, SQV/r, Partially sensitive	0 0.0%
PI, SQV/r, Sensitive	1 100.0%
PI, TPV/r, Resistant	0 0.0%
PI, TPV/r, Partially sensitive	0 0.0%
PI, TPV/r, Sensitive	1 100.0%

26. Secondary Outcome

Title	Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV - DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early+late switch phase. Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0).
Time Frame	Pre-dose at Week 4, 24, 48, 56, 76 and 100

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG 50 mg	RPV 25 mg
Arm/Group Description:		Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 148 during early switch and late switch phase.	Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 148 during early switch and late switch phase.
Overall Number of Participants Analyzed		254	254
Mean (Standard Deviation); Unit of Measure: ug/ L
Week 4, n=176, 175	Number Analyzed	176 participants	175 participants
		1578.88 (1170.967)	79.50 (38.230)
Week 24, n=207, 207	Number Analyzed	207 participants	207 participants
		1447.23 (917.677)	90.21 (46.302)
Week 48, n=215, 215	Number Analyzed	215 participants	215 participants
		1384.36 (889.829)	91.41 (47.073)
Week 56, n=214, 213	Number Analyzed	214 participants	213 participants
		1637.74 (1063.391)	90.55 (45.686)
Week 76, n=219, 219	Number Analyzed	219 participants	219 participants
		1507.81 (913.263)	92.51 (46.223)
Week 100, n=220, 221	Number Analyzed	220 participants	221 participants
		1532.10 (916.975)	91.98 (44.683)

27. Secondary Outcome

Title	Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG + RPV - CAR Late Switch Group Through Late Switch Phase
Description	Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase. LS PK Parameter Population comprised of all participants who were randomized to CAR and received DTG + RPV in the Late Switch Phase and provided at least one evaluable estimate of C0.
Time Frame	Pre-dose at Weeks 56, 76 and 100

Outcome Measure Data

Analysis Population Description

LS PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		CAR-DTG 50 mg	CAR-RPV 25 mg
Arm/Group Description:		Participants from CAR arm received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.	Participants from CAR arm received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
Overall Number of Participants Analyzed		226	226
Mean (Standard Deviation); Unit of Measure: ug/ L
Week 56, n=203, 203	Number Analyzed	203 participants	203 participants
		1544.75 (1049.595)	77.27 (38.931)
Week 76, n=210, 210	Number Analyzed	210 participants	210 participants
		1806.77 (1019.300)	91.46 (48.568)
Week 100, n=215, 215	Number Analyzed	215 participants	215 participants
		1881.97 (1160.587)	90.89 (47.762)

28. Secondary Outcome

Title	Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Description	Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.
Time Frame	Pre-dose at Weeks 2, 4 and 8

Outcome Measure Data

Analysis Population Description

PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG 50 mg	RPV 25 mg
Arm/Group Description:		Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.	Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
Overall Number of Participants Analyzed		28	28
Mean (Standard Deviation); Unit of Measure: ug/ L
Week 2, n=19, 19	Number Analyzed	19 participants	19 participants
		834.58 (639.622)	57.342 (29.5436)
Week 4, n=22, 21	Number Analyzed	22 participants	21 participants
		1218.23 (842.703)	78.338 (31.4825)
Week 8, n=26, 26	Number Analyzed	26 participants	26 participants
		1472.50 (818.774)	79.652 (40.7546)

29. Secondary Outcome

Title	Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
Description	Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Measure Type: Number; Unit of Measure: Percentage of participants
NNRTI, n=144, 144	Number Analyzed	144 participants	144 participants
		97	93
INSTI, n=59, 49	Number Analyzed	59 participants	49 participants
		92	94
PI, n=58, 62	Number Analyzed	58 participants	62 participants
		91	97

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.179
	Comments	One-sided p-value from weighted least squares chi-squared statistic. A p-value <=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.
	Method	Chi-squared, Corrected
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 95%; -1.6 to 8.6
	Estimation Comments	NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -12.1 to 7.4
	Estimation Comments	INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-5.4
	Confidence Interval	(2-Sided) 95%; -13.9 to 3.1
	Estimation Comments	PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.

30. Secondary Outcome

Title	Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Cells per mm^3
NNRTI, n=139, 133	Number Analyzed	139 participants	133 participants
		49.7 (166.40)	24.3 (160.32)
INSTI, n=53, 46	Number Analyzed	53 participants	46 participants
		-11.2 (176.56)	10.3 (155.53)
PI, n=53, 61	Number Analyzed	53 participants	61 participants
		10.5 (163.67)	12.2 (163.32)

31. Secondary Outcome

Title	Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Description	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Measure Type: Count of Participants; Unit of Measure: Participants
Any AE, NNRTI, n=144, 144	Number Analyzed	144 participants	144 participants
		106 73.6%	96 66.7%
Any AE, INSTI, n=59, 49	Number Analyzed	59 participants	49 participants
		47 79.7%	36 73.5%
Any AE, PI, n=58, 62	Number Analyzed	58 participants	62 participants
		42 72.4%	42 67.7%
NNRTI, Maximum toxicity Grade 1 AE, n=144, 144	Number Analyzed	144 participants	144 participants
		68 47.2%	76 52.8%
NNRTI, Maximum toxicity Grade 2 AE, n=144, 144	Number Analyzed	144 participants	144 participants
		30 20.8%	19 13.2%
NNRTI, Maximum toxicity Grade 3 AE, n=144, 144	Number Analyzed	144 participants	144 participants
		8 5.6%	0 0.0%
NNRTI, Maximum toxicity Grade 4 AE, n=144, 144	Number Analyzed	144 participants	144 participants
		0 0.0%	1 0.7%
INSTI, Maximum toxicity Grade 1 AE, n=59, 49	Number Analyzed	59 participants	49 participants
		27 45.8%	20 40.8%
INSTI, Maximum toxicity Grade 2 AE, n=59, 49	Number Analyzed	59 participants	49 participants
		15 25.4%	15 30.6%
INSTI, Maximum toxicity Grade 3 AE, n=59, 49	Number Analyzed	59 participants	49 participants
		5 8.5%	1 2.0%
INSTI, Maximum toxicity Grade 4 AE, n=59, 49	Number Analyzed	59 participants	49 participants
		0 0.0%	0 0.0%
PI, Maximum toxicity Grade 1 AE, n=58, 62	Number Analyzed	58 participants	62 participants
		24 41.4%	26 41.9%
PI, Maximum toxicity Grade 2 AE, n=58, 62	Number Analyzed	58 participants	62 participants
		14 24.1%	13 21.0%
PI, Maximum toxicity Grade 3 AE, n=58, 62	Number Analyzed	58 participants	62 participants
		3 5.2%	3 4.8%
PI, Maximum toxicity Grade 4 AE, n=58, 62	Number Analyzed	58 participants	62 participants
		1 1.7%	0 0.0%
AELD, NNRTI, n=144, 144	Number Analyzed	144 participants	144 participants
		5 3.5%	1 0.7%
AELD, INSTI, n=59, 49	Number Analyzed	59 participants	49 participants
		4 6.8%	0 0.0%
AELD, PI, n=58, 62	Number Analyzed	58 participants	62 participants
		3 5.2%	0 0.0%

32. Secondary Outcome

Title	Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Description	Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI, Grade 1, n=144, 144	Number Analyzed	144 participants	144 participants
		51 35.4%	52 36.1%
NNRTI, Grade 2, n=144, 144	Number Analyzed	144 participants	144 participants
		31 21.5%	40 27.8%
NNRTI, Grade 3, n=144, 144	Number Analyzed	144 participants	144 participants
		7 4.9%	4 2.8%
NNRTI, Grade 4, n=144, 144	Number Analyzed	144 participants	144 participants
		1 0.7%	5 3.5%
INSTI, Grade 1, n= 59, 49	Number Analyzed	59 participants	49 participants
		19 32.2%	11 22.4%
INSTI, Grade 2, n=59, 49	Number Analyzed	59 participants	49 participants
		23 39.0%	18 36.7%
INSTI, Grade 3, n= 59, 49	Number Analyzed	59 participants	49 participants
		3 5.1%	3 6.1%
INSTI, Grade 4, n= 59, 49	Number Analyzed	59 participants	49 participants
		0 0.0%	2 4.1%
PI, Grade 1, n= 58, 62	Number Analyzed	58 participants	62 participants
		22 37.9%	17 27.4%
PI, Grade 2, n= 58, 62	Number Analyzed	58 participants	62 participants
		18 31.0%	21 33.9%
PI, Grade 3, n= 58, 62	Number Analyzed	58 participants	62 participants
		1 1.7%	9 14.5%
PI, Grade 4, n= 58, 62	Number Analyzed	58 participants	62 participants
		0 0.0%	3 4.8%

33. Secondary Outcome

Title	Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Description	Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI; Grade 1; n= 144, 144	Number Analyzed	144 participants	144 participants
		7 4.9%	6 4.2%
NNRTI; Grade 2; n= 144, 144	Number Analyzed	144 participants	144 participants
		1 0.7%	2 1.4%
NNRTI; Grade 3; n= 144, 144	Number Analyzed	144 participants	144 participants
		1 0.7%	0 0.0%
NNRTI; Grade 4; n= 144, 144	Number Analyzed	144 participants	144 participants
		1 0.7%	0 0.0%
INI; Grade 1; n-= 59, 49	Number Analyzed	59 participants	49 participants
		1 1.7%	1 2.0%
INI; Grade 2; n-= 59, 49	Number Analyzed	59 participants	49 participants
		0 0.0%	0 0.0%
INI; Grade 3; n-= 59, 49	Number Analyzed	59 participants	49 participants
		0 0.0%	0 0.0%
INI; Grade 4; n-= 59, 49	Number Analyzed	59 participants	49 participants
		0 0.0%	0 0.0%
PI; Grade 1; n= 58, 62	Number Analyzed	58 participants	62 participants
		3 5.2%	4 6.5%
PI; Grade 2; n= 58, 62	Number Analyzed	58 participants	62 participants
		1 1.7%	0 0.0%
PI; Grade 3; n= 58, 62	Number Analyzed	58 participants	62 participants
		2 3.4%	0 0.0%
PI; Grade 4; n= 58, 62	Number Analyzed	58 participants	62 participants
		0 0.0%	0 0.0%

34. Secondary Outcome

Title	Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
Description	For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

CVW resistance Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

35. Secondary Outcome

Title	Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
Description	For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

CVW resistance Population

Arm/Group Title	DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

36. Secondary Outcome

Title	Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Description	Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1), Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: mmol/L
CHO, Week 24, overall, n=237, 229	Number Analyzed	237 participants	229 participants
		1.015 (15.7472)	1.300 (12.2269)
CHO, Week 48, overall, n=237, 230	Number Analyzed	237 participants	230 participants
		-0.165 (15.9301)	0.194 (13.1071)
CHO, Week 24, NNRTI, n=0, 132	Number Analyzed	0 participants	132 participants
			1.238 (12.4889)
CHO, Week 48, NNRTI, n=0, 128	Number Analyzed	0 participants	128 participants
			0.281 (12.2469)
CHO, Week 24, INSTI, n=0, 42	Number Analyzed	0 participants	42 participants
			1.973 (12.1365)
CHO, Week 48, INSTI, n=0, 44	Number Analyzed	0 participants	44 participants
			2.798 (16.1468)
CHO, Week 24, PI, n=0, 55	Number Analyzed	0 participants	55 participants
			0.936 (11.8530)
CHO, Week 48, PI, n=0, 58	Number Analyzed	0 participants	58 participants
			-1.971 (12.2195)
HDL CHO direct, Overall, Week 24, n=237, 229	Number Analyzed	237 participants	229 participants
		0.557 (19.4929)	-2.533 (16.3641)
HDL CHO direct, Overall, Week 48, n=237,230	Number Analyzed	237 participants	230 participants
		6.384 (20.9244)	4.723 (18.3253)
HDL CHO direct, NNRTI, Week 24, n=0, 132	Number Analyzed	0 participants	132 participants
			-2.562 (15.3521)
HDL CHO direct, NNRTI, Week 48, n=0, 128	Number Analyzed	0 participants	128 participants
			4.307 (17.8013)
HDL CHO direct, INSTI, Week 24, n=0, 42	Number Analyzed	0 participants	42 participants
			-3.097 (20.0002)
HDL CHO direct, INSTI, Week 48, n=0, 44	Number Analyzed	0 participants	44 participants
			5.386 (20.6791)
HDL CHO direct, PI, Week 24, n=0, 55	Number Analyzed	0 participants	55 participants
			-2.031 (15.9582)
HDL CHO direct, PI, Week 48, n=0, 58	Number Analyzed	0 participants	58 participants
			5.140 (17.8779)
LDL CHO calculation, Overall, Week 24, n=231, 221	Number Analyzed	231 participants	221 participants
		5.838 (22.9614)	4.395 (21.6685)
LDL CHO calculation, Overall, Week 48, n=229, 220	Number Analyzed	229 participants	220 participants
		1.137 (23.3849)	-0.598 (20.6931)
LDL CHO calculation, NNRTI, Week 24, n=0, 129	Number Analyzed	0 participants	129 participants
			5.959 (21.5692)
LDL CHO calculation, NNRTI, Week 48, n=0, 124	Number Analyzed	0 participants	124 participants
			0.747 (19.2299)
LDL CHO calculation, INSTI, Week 24, n=0, 40	Number Analyzed	0 participants	40 participants
			3.787 (17.6755)
LDL CHO calculation, INSTI, Week 48, n=0, 42	Number Analyzed	0 participants	42 participants
			2.647 (24.0430)
LDL CHO calculation, PI, Week 24, n=0, 52	Number Analyzed	0 participants	52 participants
			0.983 (24.5052)
LDL CHO calculation, PI, Week 48, n=0, 54	Number Analyzed	0 participants	54 participants
			-6.212 (20.4774)
Triglycerides, Overall, Week 24, n=237, 229	Number Analyzed	237 participants	229 participants
		-0.825 (42.5565)	9.379 (45.5529)
Triglycerides, Overall, Week 48, n=237, 230	Number Analyzed	237 participants	230 participants
		1.169 (51.9844)	7.183 (44.7044)
Triglycerides, NNRTI, Week 24, n=0, 132	Number Analyzed	0 participants	132 participants
			4.962 (40.6201)
Triglycerides, NNRTI, Week 48, n=0, 128	Number Analyzed	0 participants	128 participants
			5.248 (41.7728)
Triglycerides, INSTI, Week 24, n=0, 42	Number Analyzed	0 participants	42 participants
			18.204 (47.2348)
Triglycerides, INSTI, Week 48, n=0, 44	Number Analyzed	0 participants	44 participants
			14.627 (56.2824)
Triglycerides, PI, Week 24, n=0,55	Number Analyzed	0 participants	55 participants
			13.241 (54.2327)
Triglycerides, PI, Week 48, n=0, 58	Number Analyzed	0 participants	58 participants
			5.806 (41.2106)

37. Secondary Outcome

Title	Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Description	The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1), Weeks 4, 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		DTG + RPV	Current Antiretroviral Regimen
Arm/Group Description:		Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		261	255
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Symptom count, Week 4, n=224, 229	Number Analyzed	224 participants	229 participants
		-1.1 (4.11)	-0.8 (4.02)
Symptom count, Week 24, n=228, 232	Number Analyzed	228 participants	232 participants
		-0.7 (4.31)	-0.8 (4.64)
Symptom count, Week 48, n=228, 231	Number Analyzed	228 participants	231 participants
		-0.5 (4.33)	-0.4 (4.82)
Symptom Bother Score, Week 4, n=224, 229	Number Analyzed	224 participants	229 participants
		-2.8 (7.44)	-1.8 (7.24)
Symptom Bother Score, Week 24, n=228, 232	Number Analyzed	228 participants	232 participants
		-1.8 (8.40)	-1.7 (8.72)
Symptom Bother Score, Week 48, n=228, 231	Number Analyzed	228 participants	231 participants
		-1.5 (7.97)	-0.7 (9.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.430
	Comments	P-value for interaction between treatment group and Baseline symptom bother score (Week 4)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.039
	Comments	P value to assess difference between treatment groups (Symptom Bother Score - Week 4)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.239
	Confidence Interval	(2-Sided) 95%; -2.414 to -0.064
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.542
	Comments	P-value for interaction between treatment group and Baseline symptom bother score (Week 24)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.448
	Comments	P value to assess difference between treatment groups (Symptom Bother Score - Week 24)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.528
	Confidence Interval	(2-Sided) 95%; -1.896 to 0.840
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.402
	Comments	P-value for interaction between treatment group and Baseline symptom bother score (Week 48)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.164
	Comments	P value to assess difference between treatment groups (Symptom Bother Score - Week 48)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.037
	Confidence Interval	(2-Sided) 95%; -2.501 to 0.426
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

38. Secondary Outcome

Title	Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1), Weeks 56, 76, 100 and 148

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	DTG + RPV
Arm/Group Description:	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Overall Number of Participants Analyzed	228
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Symptom count, Week 56	-0.8 (4.80)
Symptom count, Week 76	-0.6 (4.66)
Symptom count, Week 100	-0.5 (5.03)
Symptom count, Week 148	-0.7 (4.87)
Symptom Bother Score, Week 56	-1.8 (9.23)
Symptom Bother Score, Week 76	-1.6 (8.70)
Symptom Bother Score, Week 100	-1.4 (9.40)
Symptom Bother Score, Week 148	-1.7 (9.54)

39. Secondary Outcome

Title	Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase
Description	The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Time Frame	LS Baseline (Week 48), Weeks 56, 76, 100 and 148

Outcome Measure Data

Analysis Population Description

LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Arm/Group Title		Current Antiretroviral Regimen
Arm/Group Description:		Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
Overall Number of Participants Analyzed		239
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Symptom count, Week 56, n=216	Number Analyzed	216 participants
		-0.9 (4.74)
Symptom count, Week 76, n=220	Number Analyzed	220 participants
		-0.7 (4.29)
Symptom count, Week 100, n=220	Number Analyzed	220 participants
		-0.4 (5.04)
Symptom count, Week 148, n=220	Number Analyzed	220 participants
		-0.6 (4.81)
Symptom Bother Score, Week 56 n=216	Number Analyzed	216 participants
		-2.1 (7.56)
Symptom Bother Score, Week 76, n=220	Number Analyzed	220 participants
		-1.0 (7.61)
Symptom Bother Score, Week 100, n=220	Number Analyzed	220 participants
		-0.8 (8.43)