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

• ClinicalTrials.gov Identifier: NCT02429791
• Recruitment Status: Active, not recruiting
• First Posted: April 29, 2015
• Results First Posted: December 2, 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: 510

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 65 centers in 13 countries.
Pre-assignment Details	Total 641 participants were screened (131 failed), 510 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	252	256
Completed	239	238
Not Completed	13	18
Reason Not Completed
Adverse Event	6	2
Physician Decision	0	2
Lack of Efficacy	2	1
Lost to Follow-up	1	2
Protocol Violation	1	4
Withdrawal by Subject	3	7
Period Title: Late Switch Phase (Week 52 to Week 148)
Started	239	238
Completed	214	210
Not Completed	25	28
Reason Not Completed
Adverse Event	11	12
Physician Decision	0	4
Lack of Efficacy	4	3
Lost to Follow-up	0	1
Protocol Violation	3	3
Withdrawal by Subject	7	5

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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256	508
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	252 participants	256 participants	508 participants
		43.6 (10.93)	43.6 (10.76)	43.6 (10.84)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	252 participants	256 participants	508 participants
	Female	58 23.0%	51 19.9%	109 21.5%
	Male	194 77.0%	205 80.1%	399 78.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	252 participants	256 participants	508 participants
American Indian or Alaska Native		3 1.2%	6 2.3%	9 1.8%
Japanese/East Asian (EA) Heritage (H.)/South EA H.		25 9.9%	34 13.3%	59 11.6%
Black/African American		24 9.5%	27 10.5%	51 10.0%
Native Hawaiian or other Pacific Islander		1 0.4%	0 0.0%	1 0.2%
White		198 78.6%	188 73.4%	386 76.0%
American Indian or Alaska Native and white		0 0.0%	1 0.4%	1 0.2%
African American/African H. and Asian		1 0.4%	0 0.0%	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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	252	256
Measure Type: Number; Unit of Measure: Percentage of participants
	95	96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -10%.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -4.3 to 3.0
	Estimation Comments	Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INI).

2. Secondary Outcome

Title	Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
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. Value obtained at Day 1 was considered as Baseline value. 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Cells per millimeter cube (mm^3)
Week 24, n=247, 249	Number Analyzed	247 participants	249 participants
		16.2 (150.34)	47.4 (179.68)
Week 48, n=239, 245	Number Analyzed	239 participants	245 participants
		32.3 (149.52)	41.8 (185.53)

3. Secondary Outcome

Title	Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	252	256
Measure Type: Number; Unit of Measure: Percentage of participants
	98	96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.9 to 4.0
	Estimation Comments	Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.

4. Secondary Outcome

Title	Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
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 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 participant or may require medical or surgical intervention were categorized as SAE. AEs were graded as per Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; grade 2=moderate; grade 3=severe; 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 have 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	252	256
Measure Type: Count of Participants; Unit of Measure: Participants
Common non-serious AE	65 25.8%	68 26.6%
Any SAE	9 3.6%	12 4.7%
Maximum Grade 1 AE	128 50.8%	122 47.7%
Maximum toxicity Grade 2 AE	57 22.6%	53 20.7%
Maximum toxicity Grade 3 AE	11 4.4%	13 5.1%
Maximum toxicity Grade 4 AE	4 1.6%	2 0.8%
AELD	9 3.6%	2 0.8%

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 DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	252	256
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	95 37.7%	78 30.5%
Grade 2	61 24.2%	86 33.6%
Grade 3	22 8.7%	23 9.0%
Grade 4	5 2.0%	9 3.5%

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 DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	252	256
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	11 4.4%	11 4.3%
Grade 2	3 1.2%	2 0.8%
Grade 3	3 1.2%	1 0.4%
Grade 4	0 0.0%	1 0.4%

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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	234	243
Mean (Standard Deviation); Unit of Measure: mg/ Liter (L)
	0.11 (5.379)	0.15 (4.944)

8. Secondary Outcome

Title	Mean Change From Baseline in Cystatin C at Week 48
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	245
Mean (Standard Deviation); Unit of Measure: mg/L
	0.00 (0.113)	-0.01 (0.106)

9. Secondary Outcome

Title	Mean Change From Baseline in D-Dimer at Week 48
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	224	238
Mean (Standard Deviation); Unit of Measure: Nanomole/L fibrinogen equivalent units
	-0.02 (2.651)	0.02 (2.501)

10. Secondary Outcome

Title	Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Nanogram/milliliter
FABP, n=233, 242	Number Analyzed	233 participants	242 participants
		-2.79 (3.007)	-1.93 (2.150)
Soluble CD14, n=234, 242	Number Analyzed	234 participants	242 participants
		379.72 (634.053)	754.54 (656.462)

11. Secondary Outcome

Title	Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Microgram (ug)/Liter
Soluble CD163, n=232, 241	Number Analyzed	232 participants	241 participants
		50.18 (188.772)	54.26 (238.900)
Oxidized LDL, n=234, 242	Number Analyzed	234 participants	242 participants
		9.49 (745.962)	-41.30 (726.014)

12. Secondary Outcome

Title	Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: mg/deciliter (dL)
RBP, n=235, 243	Number Analyzed	235 participants	243 participants
		-0.13 (1.023)	0.03 (0.974)
Serum creatinine, n=238, 243	Number Analyzed	238 participants	243 participants
		0.087 (0.1074)	0.011 (0.0876)
Glucose, n=227, 227	Number Analyzed	227 participants	227 participants
		0.762 (13.6194)	2.492 (12.1674)

13. Secondary Outcome

Title	Mean Change From Baseline in Urine Phosphate at Week 48
Description	Urine biomarker samples were collected 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	218	224
Mean (Standard Deviation); Unit of Measure: Millimoles (mmol)/ L
	-1.079 (16.9226)	-1.511 (15.8515)

14. Secondary Outcome

Title	Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (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 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Nanomoles/ L
Blood B2M, n=233, 241	Number Analyzed	233 participants	241 participants
		-15.1452 (44.55903)	-4.5995 (38.90474)
Blood 25 hydroxy-vitamin D, n=235, 244	Number Analyzed	235 participants	244 participants
		-13.9 (22.76)	-8.2 (24.43)
Urine B2M, n=89, 96	Number Analyzed	89 participants	96 participants
		-128.2045 (726.38825)	39.8394 (253.43025)
Urine RBP, n=221, 231	Number Analyzed	221 participants	231 participants
		-8.8395 (28.83977)	-0.5851 (27.56405)

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	0.275
	Comments	P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.958
	Confidence Interval	(2-Sided) 95%; 0.888 to 1.034
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.112
	Comments	P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.902
	Confidence Interval	(2-Sided) 95%; 0.793 to 1.025
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.847
	Confidence Interval	(2-Sided) 95%; 0.763 to 0.942
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.

15. Secondary Outcome

Title	Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Grams (g)/ mol
Urine albumin/creatinine ratio, n=166, 171	Number Analyzed	166 participants	171 participants
		-1.19 (3.916)	-2.59 (28.878)
urine protein/creatinine ratio, n=176, 182	Number Analyzed	176 participants	182 participants
		-5.63 (17.219)	-1.43 (42.832)

16. Secondary Outcome

Title	Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type I Collagen C-Telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: ug/ L
Bone-specific alkaline phosphatase, n=234, 244	Number Analyzed	234 participants	244 participants
		-2.89 (4.024)	0.90 (4.129)
Procollagen type 1 N-propeptide, n=234, 242	Number Analyzed	234 participants	242 participants
		-9.1 (20.34)	-1.4 (18.95)
Osteocalcin, n=233, 242	Number Analyzed	233 participants	242 participants
		-4.40 (7.605)	-0.68 (6.579)
Type I Collagen C-Telopeptides, n=234, 241	Number Analyzed	234 participants	241 participants
		-0.18 (0.307)	-0.04 (1.160)
sVCAM, n=234, 243	Number Analyzed	234 participants	243 participants
		-2.21 (1291.994)	89.07 (1239.465)

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	0.724
	Confidence Interval	(2-Sided) 95%; 0.679 to 0.772
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.825
	Confidence Interval	(2-Sided) 95%; 0.742 to 0.918
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.810
	Confidence Interval	(2-Sided) 95%; 0.742 to 0.884
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

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	0.817
	Confidence Interval	(2-Sided) 95%; 0.774 to 0.863
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

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	0.881
	Confidence Interval	(2-Sided) 95%; 0.823 to 0.943
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	P value to assess difference between treatment groups (osteocalcin - INI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.829
	Confidence Interval	(2-Sided) 95%; 0.740 to 0.930
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (osteocalcin - PI)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.691
	Confidence Interval	(2-Sided) 95%; 0.628 to 0.759
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

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	0.804
	Confidence Interval	(2-Sided) 95%; 0.742 to 0.872
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.

17. Secondary Outcome

Title	Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
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 point 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	233	243
Mean (Standard Deviation); Unit of Measure: Nanograms (ng)/ L
	0.17 (2.736)	-0.18 (2.944)

18. Secondary Outcome

Title	Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
Description	Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR) index, the product of basal glucose and insulin levels divided by 22.5 (1,2), is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Time Frame	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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	229	237
Mean (Standard Deviation); Unit of Measure: HOMA-IR Score
	-0.30 (5.740)	0.51 (3.530)

19. Secondary Outcome

Title	Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
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), Week 24 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: mmol/ L
Total cholesterol, Week 24, n=228, 223	Number Analyzed	228 participants	223 participants
		0.076 (0.8398)	0.061 (0.7368)
Total cholesterol, Week 48, n=221, 218	Number Analyzed	221 participants	218 participants
		0.089 (0.8488)	0.064 (0.7197)
LDL cholesterol calculation, Week 24, n=224, 217	Number Analyzed	224 participants	217 participants
		0.165 (0.7065)	0.103 (0.6503)
LDL cholesterol calculation, Week 48, n=215, 211	Number Analyzed	215 participants	211 participants
		0.108 (0.7178)	0.029 (0.6134)
HDL cholesterol direct, Week 24, n=228, 223	Number Analyzed	228 participants	223 participants
		-0.030 (0.2601)	-0.044 (0.2394)
HDL cholesterol direct, Week 48, n=221, 218	Number Analyzed	221 participants	218 participants
		0.023 (0.2757)	0.018 (0.2722)
Triglycerides, Week 24, n=228, 223	Number Analyzed	228 participants	223 participants
		-0.154 (0.7324)	-0.001 (0.7712)
Triglycerides, Week 48, n=221, 218	Number Analyzed	221 participants	218 participants
		-0.093 (0.9767)	0.046 (0.8274)

20. Secondary Outcome

Title	Number of Participants With Genotypic Resistance- Early Switch Phase
Description	Plasma samples were collected for drug resistance testing. Confirmed Virologic Withdrawal (CVW) resistance Population comprised of all participants in the ITT-E Population who met confirmed 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 was met. Genotypic Resistance data for the following drugs (Rilpivirine [RPV], Dolutegravir [DTG], Emtricitabine [FTC], Tenofovir [TDF], Darunavir/r [DRV/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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	1
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI, RPV, Susceptible	1 100.0%	NA [1]
NNRTI, RPV, Potential low-level resistance	0 0.0%	NA [1]
NNRTI, RPV, Low-level resistance	0 0.0%	NA [1]
NNRTI, RPV, Intermediate resistance	0 0.0%	NA [1]
NNRTI, RPV, High-level resistance	0 0.0%	NA [1]
INI, DTG, Susceptible	1 100.0%	NA [1]
INI, DTG, Potential low-level resistance	0 0.0%	NA [1]
INI, DTG, Low-level resistance	0 0.0%	NA [1]
INI, DTG, Intermediate resistance	0 0.0%	NA [1]
INI, DTG, High-level resistance	0 0.0%	NA [1]
NRTI, FTC, Susceptible	NA [1]	1 100.0%
NRTI, FTC, Potential low-level resistance	NA [1]	0 0.0%
NRTI, FTC, Low-level resistance	NA [1]	0 0.0%
NRTI, FTC, Intermediate resistance	NA [1]	0 0.0%
NRTI, FTC, High-level resistance	NA [1]	0 0.0%
NRTI, TDF, Susceptible	NA [1]	1 100.0%
NRTI, TDF, Potential low-level resistance	NA [1]	0 0.0%
NRTI, TDF, Low-level resistance	NA [1]	0 0.0%
NRTI, TDF, Intermediate resistance	NA [1]	0 0.0%
NRTI, TDF, High-level resistance	NA [1]	0 0.0%
PI, DRV/r, Susceptible	NA [1]	1 100.0%
PI, DRV/r, Potential low-level resistance	NA [1]	0 0.0%
PI, DRV/r, Low-level resistance	NA [1]	0 0.0%
PI, DRV/r, Intermediate resistance	NA [1]	0 0.0%
PI, DRV/r, High-level resistance	NA [1]	0 0.0%

[1]

NA indicates data was not applicable as the drugs were not received. Genotypic resistance data is only shown for drugs received for Participants Meeting Confirmed Virologic Withdrawal Criteria

21. Secondary Outcome

Title	Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Group 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 CVW 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	5
Measure Type: Count of Participants; Unit of Measure: Participants
INI, DTG, Susceptible	5 100.0%
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	4 80.0%
INI, EVG, Potential low-level resistance	1 20.0%
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	4 80.0%
INI, RAL, Potential low-level resistance	1 20.0%
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	5 100.0%
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	3 60.0%
NNRTI, EFV, Potential low-level resistance	0 0.0%
NNRTI, EFV, Low-level resistance	0 0.0%
NNRTI, EFV, Intermediate resistance	1 20.0%
NNRTI, EFV, High-level resistance	1 20.0%
NNRTI, ETR, Susceptible	3 60.0%
NNRTI, ETR, Potential low-level resistance	1 20.0%
NNRTI, ETR, Low-level resistance	0 0.0%
NNRTI, ETR, Intermediate resistance	1 20.0%
NNRTI, ETR, High-level resistance	0 0.0%
NNRTI,NVP, Susceptible	3 60.0%
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	2 40.0%
NNRTI, RPV, Susceptible	3 60.0%
NNRTI, RPV, Potential low-level resistance	0 0.0%
NNRTI, RPV, Low-level resistance	1 20.0%
NNRTI, RPV, Intermediate resistance	0 0.0%
NNRTI, RPV, High-level resistance	1 20.0%
NRTI, 3TC, Susceptible	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	4 80.0%
NRTI, ZDV, Potential low-level resistance	1 20.0%
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	4 80.0%
NRTI, d4T, Potential low-level resistance	1 20.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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	5 100.0%
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 Group Through Late Switch Phase
Description	Plasma samples were collected for drug resistance testing. 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 was met. 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.
Time Frame	Post-LS Baseline (Week 52) up to Week 148

Outcome Measure Data

Analysis Population Description

LS CVW resistance Population. Only those participants with data available at the specified time point were analyzed.

Arm/Group Title	Current Antiretroviral Regimen
Arm/Group Description:	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	1 100.0%
NNRTI, EFV, Low-level resistance	0 0.0%
NNRTI, EFV, Intermediate resistance	0 0.0%
NNRTI, EFV, High-level resistance	0 0.0%
NNRTI, ETR, Susceptible	0 0.0%
NNRTI, ETR, Potential low-level resistance	1 100.0%
NNRTI, ETR, Low-level resistance	0 0.0%
NNRTI, ETR, Intermediate resistance	0 0.0%
NNRTI, ETR, High-level resistance	0 0.0%
NNRTI,NVP, Susceptible	0 0.0%
NNRTI,NVP, Potential low-level resistance	1 100.0%
NNRTI,NVP, Low-level resistance	0 0.0%
NNRTI,NVP, Intermediate resistance	0 0.0%
NNRTI, NVP, High-level resistance	0 0.0%
NNRTI, RPV, Susceptible	0 0.0%
NNRTI, RPV, Potential low-level resistance	1 100.0%
NNRTI, RPV, Low-level resistance	0 0.0%
NNRTI, RPV, Intermediate resistance	0 0.0%
NNRTI, RPV, High-level resistance	0 0.0%
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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	1
Measure Type: Count of Participants; Unit of Measure: Participants
INI, DTG, Resistant	0 0.0%	0 0.0%
INI, DTG, Partially Sensitive	0 0.0%	0 0.0%
INI, DTG, Sensitive	1 100.0%	1 100.0%
INI, EVG, Resistant	0 0.0%	0 0.0%
INI, EVG, Sensitive	1 100.0%	1 100.0%
INI, RAL, Resistant	0 0.0%	0 0.0%
INI, RAL, Sensitive	1 100.0%	1 100.0%
NNRTI, DLV, Resistant	0 0.0%	0 0.0%
NNRTI, DLV, Sensitive	1 100.0%	1 100.0%
NNRTI, EFV, Resistant	0 0.0%	0 0.0%
NNRTI, EFV, Sensitive	1 100.0%	1 100.0%
NNRTI, ETR, Resistant	0 0.0%	0 0.0%
NNRTI, ETR, Partially Sensitive	0 0.0%	0 0.0%
NNRTI, ETR, Sensitive	1 100.0%	1 100.0%
NNRTI, NVP, Resistant	0 0.0%	0 0.0%
NNRTI, NVP, Sensitive	1 100.0%	1 100.0%
NNRTI, RPV, Resistant	0 0.0%	0 0.0%
NNRTI, RPV, Sensitive	1 100.0%	1 100.0%
NRTI, 3TC, Resistant	0 0.0%	0 0.0%
NRTI, 3TC, Sensitive	1 100.0%	1 100.0%
NRTI, ABC, Resistant	0 0.0%	0 0.0%
NRTI, ABC, Partially Sensitive	0 0.0%	0 0.0%
NRTI, ABC, Sensitive	1 100.0%	1 100.0%
NRTI,FTC, Resistant	0 0.0%	0 0.0%
NRTI, FTC, Sensitive	1 100.0%	1 100.0%
NRTI, TDF, Resistant	0 0.0%	0 0.0%
NRTI, TDF, Partially Sensitive	0 0.0%	0 0.0%
NRTI, TDF, Sensitive	1 100.0%	1 100.0%
NRTI, ZDV, Resistant	0 0.0%	0 0.0%
NRTI, ZDV, Sensitive	1 100.0%	1 100.0%
NRTI, d4T, Resistant	0 0.0%	0 0.0%
NRTI, d4T, Sensitive	1 100.0%	1 100.0%
NRTI, ddI, Resistant	0 0.0%	0 0.0%
NRTI, ddI, Partially Sensitive	0 0.0%	0 0.0%
NRTI, ddI, Sensitive	1 100.0%	1 100.0%
PI, ATV/r, Resistant	0 0.0%	0 0.0%
PI, ATV/r, Sensitive	1 100.0%	1 100.0%
PI, DRV/r, Resistant	0 0.0%	0 0.0%
PI, DRV/r, Partially Sensitive	0 0.0%	0 0.0%
PI, DRV/r, Sensitive	1 100.0%	1 100.0%
PI, FPV/r, Resistant	0 0.0%	0 0.0%
PI, FPV/r, Partially Sensitive	0 0.0%	0 0.0%
PI, FPV/r, Sensitive	1 100.0%	1 100.0%
PI, IDV/r, Resistant	0 0.0%	0 0.0%
PI, IDV/r, Sensitive	1 100.0%	1 100.0%
PI, LPV/r, Resistant	0 0.0%	0 0.0%
PI, LPV/r, Partially Sensitive	0 0.0%	0 0.0%
PI, LPV/r, Sensitive	1 100.0%	1 100.0%
PI, NFV, Resistant	0 0.0%	0 0.0%
PI, NFV, Sensitive	1 100.0%	1 100.0%
PI, RTV, Resistant	0 0.0%	0 0.0%
PI, RTV, Sensitive	1 100.0%	1 100.0%
PI, SQV/r, Resistant	0 0.0%	0 0.0%
PI, SQV/r, Partially Sensitive	0 0.0%	0 0.0%
PI, SQV/r, Sensitive	1 100.0%	1 100.0%
PI, TPV/r, Resistant	0 0.0%	0 0.0%
PI, TPV/r, Partially Sensitive	0 0.0%	0 0.0%
PI, TPV/r, Sensitive	1 100.0%	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

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	5
Measure Type: Count of Participants; Unit of Measure: Participants
INI, DTG, Resistant	0 0.0%
INI, DTG, Partially Sensitive	0 0.0%
INI, DTG, Sensitive	5 100.0%
INI, EVG, Resistant	0 0.0%
INI, EVG, Partially Sensitive	0 0.0%
INI, EVG, Sensitive	5 100.0%
INI, RAL, Resistant	0 0.0%
INI, RAL, Partially Sensitive	0 0.0%
INI, RAL, Sensitive	5 100.0%
NNRTI, DLV, Resistant	1 20.0%
NNRTI, DLV, Partially Sensitive	0 0.0%
NNRTI, DLV, Sensitive	4 80.0%
NNRTI, EFV, Resistant	1 20.0%
NNRTI, EFV, Partially Sensitive	0 0.0%
NNRTI, EFV, Sensitive	4 80.0%
NNRTI, ETR, Resistant	0 0.0%
NNRTI, ETR, Partially Sensitive	1 20.0%
NNRTI, ETR, Sensitive	4 80.0%
NNRTI, NVP, Resistant	1 20.0%
NNRTI, NVP, Partially Sensitive	0 0.0%
NNRTI, NVP, Sensitive	4 80.0%
NNRTI, RPV, Resistant	1 20.0%
NNRTI, RPV, Partially Sensitive	0 0.0%
NNRTI, RPV, Sensitive	4 80.0%
NRTI, 3TC, Resistant	0 0.0%
NRTI, 3TC, Partially Sensitive	0 0.0%
NRTI, 3TC, Sensitive	5 100.0%
NRTI, ABC, Resistant	0 0.0%
NRTI, ABC, Partially Sensitive	0 0.0%
NRTI, ABC, Sensitive	5 100.0%
NRTI, FTC, Resistant	0 0.0%
NRTI, FTC, Partially Sensitive	0 0.0%
NRTI, FTC, Sensitive	5 100.0%
NRTI, TDF, Resistant	0 0.0%
NRTI, TDF, Partially Sensitive	0 0.0%
NRTI, TDF, Sensitive	5 100.0%
NRTI, ZDV, Resistant	0 0.0%
NRTI, ZDV, Partially Sensitive	0 0.0%
NRTI, ZDV, Sensitive	5 100.0%
NRTI, d4T, Resistant	0 0.0%
NRTI, d4T, Partially Sensitive	0 0.0%
NRTI, d4T, Sensitive	5 100.0%
NRTI, ddI, Resistant	0 0.0%
NRTI, ddI, Partially Sensitive	0 0.0%
NRTI, ddI, Sensitive	5 100.0%
PI, ATV/r, Resistant	0 0.0%
PI, ATV/r, Partially Sensitive	0 0.0%
PI, ATV/r, Sensitive	5 100.0%
PI, DRV/r, Resistant	0 0.0%
PI, DRV/r, Partially Sensitive	0 0.0%
PI, DRV/r, Sensitive	5 100.0%
PI, FPV/r, Resistant	0 0.0%
PI, FPV/r, Partially Sensitive	0 0.0%
PI, FPV/r, Sensitive	5 100.0%
PI, IDV/r, Resistant	0 0.0%
PI, IDV/r, Partially Sensitive	0 0.0%
PI, IDV/r, Sensitive	5 100.0%
PI, LPV/r, Resistant	0 0.0%
PI, LPV/r, Partially Sensitive	0 0.0%
PI, LPV/r, Sensitive	5 100.0%
PI, NFV, Resistant	0 0.0%
PI, NFV, Partially Sensitive	0 0.0%
PI, NFV, Sensitive	5 100.0%
PI, RTV, Resistant	0 0.0%
PI, RTV, Partially Sensitive	0 0.0%
PI, RTV, Sensitive	5 100.0%
PI, SQV/r, Resistant	0 0.0%
PI, SQV/r, Partially Sensitive	0 0.0%
PI, SQV/r, Sensitive	5 100.0%
PI, TPV/r, Resistant	0 0.0%
PI, TPV/r, Partially Sensitive	0 0.0%
PI, TPV/r, Sensitive	5 100.0%

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 (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. Only those participants with data available at the specified time point were analyzed.

Arm/Group Title	Current Antiretroviral Regimen
Arm/Group Description:	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	0 0.0%
NNRTI, ETR, Sensitive	1 100.0%
NNRTI, NVP, Resistant	1 100.0%
NNRTI, NVP, Partially Sensitive	0 0.0%
NNRTI, NVP, Sensitive	0 0.0%
NNRTI, RPV, Resistant	0 0.0%
NNRTI, RPV, Partially Sensitive	0 0.0%
NNRTI, RPV, Sensitive	1 100.0%
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 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		243	243
Mean (Standard Deviation); Unit of Measure: ug/ L
Week 4, n=130, 130	Number Analyzed	130 participants	130 participants
		1581.06 (1146.860)	92.05 (138.288)
Week 24, n=210, 210	Number Analyzed	210 participants	210 participants
		1835.68 (1120.539)	87.88 (39.141)
Week 48, n=215, 211	Number Analyzed	215 participants	211 participants
		1915.11 (1304.238)	95.18 (48.228)
Week 56, n=204, 204	Number Analyzed	204 participants	204 participants
		1872.65 (1173.815)	95.38 (53.602)
Week 76, n=194,194	Number Analyzed	194 participants	194 participants
		1711.83 (1092.143)	88.10 (42.250)
Week 100, n=203, 203	Number Analyzed	203 participants	203 participants
		1854.17 (1197.958)	92.38 (44.604)

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 Pre-dose concentration.
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		225	225
Mean (Standard Deviation); Unit of Measure: ug/ L
Week 56, n=198, 198	Number Analyzed	198 participants	198 participants
		1738.55 (1329.931)	84.14 (47.290)
Week 76, n=192, 192	Number Analyzed	192 participants	192 participants
		1800.39 (1162.370)	97.79 (52.532)
Week 100, n=192, 191	Number Analyzed	192 participants	191 participants
		1907.20 (1235.676)	101.93 (63.296)

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 2,4 and 8 only for the first 20 participants who switch from EFV or NVP to DTG + RPV. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. 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 2,4 and 8.
Time Frame	Pre-dose at Week 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		26	26
Mean (Standard Deviation); Unit of Measure: ug/ L
Week 2, n=16, 15	Number Analyzed	16 participants	15 participants
		821.25 (574.607)	65.360 (31.2965)
Week 4, n=19, 19	Number Analyzed	19 participants	19 participants
		994.00 (581.201)	67.374 (27.5663)
Week 8, n=19, 19	Number Analyzed	19 participants	19 participants
		1561.34 (1096.381)	77.416 (37.7129)

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 (INI, NNRTI, or PI) on efficacy of DTG +RPV compared to continuation of CAR. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class and age group.
Time Frame	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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Measure Type: Number; Unit of Measure: Percentage of participants
NNRTI, n=131, 134	Number Analyzed	131 participants	134 participants
		95	98
INI, n=46, 48	Number Analyzed	46 participants	48 participants
		98	96
PI, n=75, 74	Number Analyzed	75 participants	74 participants
		95	92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.317
	Comments	One-sided p-value from weighted least squares chi-squared statistic. A p-value <=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.
	Method	Chi-squared, Corrected
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -7.7 to 1.5
	Estimation Comments	NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -5.1 to 9.0
	Estimation Comments	INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; -5.3 to 10.8
	Estimation Comments	PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.

30. Secondary Outcome

Title	Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Description	Blood samples were collected for CD4 cell count assessment by flow cytometry was carried out to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Value at Day 1 was considered as Baseline. 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Cells per mm^3
NNRTI, n=124, 130	Number Analyzed	124 participants	130 participants
		47.9 (142.90)	25.0 (151.27)
INI, n=45, 46	Number Analyzed	45 participants	46 participants
		19.9 (148.63)	39.9 (200.38)
PI, n=70, 69	Number Analyzed	70 participants	69 participants
		12.5 (160.27)	74.7 (227.78)

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 (INI, NNRTI, or PI) was summarized. AEs were graded as per 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Measure Type: Count of Participants; Unit of Measure: Participants
Any AE, NNRTI, n=131, 134	Number Analyzed	131 participants	134 participants
		102 77.9%	98 73.1%
Any AE, INI, n=46, 48	Number Analyzed	46 participants	48 participants
		38 82.6%	34 70.8%
Any AE, PI, n=75, 74	Number Analyzed	75 participants	74 participants
		60 80.0%	58 78.4%
NNRTI, Maximum toxicity Grade 1 AE, n=131, 134	Number Analyzed	131 participants	134 participants
		69 52.7%	72 53.7%
NNRTI, Maximum toxicity Grade 2 AE, n=131, 134	Number Analyzed	131 participants	134 participants
		27 20.6%	23 17.2%
NNRTI, Maximum toxicity Grade 3 AE, n=131, 134	Number Analyzed	131 participants	134 participants
		5 3.8%	2 1.5%
NNRTI, Maximum toxicity Grade 4 AE, n=131, 134	Number Analyzed	131 participants	134 participants
		1 0.8%	1 0.7%
INI, Maximum toxicity Grade 1 AE, n=46, 48	Number Analyzed	46 participants	48 participants
		28 60.9%	20 41.7%
INI, Maximum toxicity Grade 2 AE, n=46, 48	Number Analyzed	46 participants	48 participants
		7 15.2%	12 25.0%
INI, Maximum toxicity Grade 3 AE, n=46, 48	Number Analyzed	46 participants	48 participants
		2 4.3%	2 4.2%
INI, Maximum toxicity Grade 4 AE, n=46, 48	Number Analyzed	46 participants	48 participants
		1 2.2%	0 0.0%
PI, Maximum toxicity Grade 1 AE, n=75, 74	Number Analyzed	75 participants	74 participants
		31 41.3%	30 40.5%
PI, Maximum toxicity Grade 2 AE, n=75, 74	Number Analyzed	75 participants	74 participants
		23 30.7%	18 24.3%
PI, Maximum toxicity Grade 3 AE, n=75, 74	Number Analyzed	75 participants	74 participants
		4 5.3%	9 12.2%
PI, Maximum toxicity Grade 4 AE, n=75, 74	Number Analyzed	75 participants	74 participants
		2 2.7%	1 1.4%
AELD, NNRTI, n=131, 134	Number Analyzed	131 participants	134 participants
		3 2.3%	0 0.0%
AELD, INI, n=46, 48	Number Analyzed	46 participants	48 participants
		2 4.3%	0 0.0%
AELD, PI, n=75, 74	Number Analyzed	75 participants	74 participants
		4 5.3%	2 2.7%

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 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INI, NNRTI, PI) was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame	Up to 48 weeks

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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI, Grade 1, n=131, 134	Number Analyzed	131 participants	134 participants
		47 35.9%	42 31.3%
NNRTI, Grade 2, n=131, 134	Number Analyzed	131 participants	134 participants
		32 24.4%	48 35.8%
NNRTI, Grade 3, n=131, 134	Number Analyzed	131 participants	134 participants
		13 9.9%	13 9.7%
NNRTI, Grade 4, n=131, 134	Number Analyzed	131 participants	134 participants
		2 1.5%	3 2.2%
INI, Grade 1, n= 46, 48	Number Analyzed	46 participants	48 participants
		13 28.3%	11 22.9%
INI, Grade 2, n= 46, 48	Number Analyzed	46 participants	48 participants
		19 41.3%	15 31.3%
INI, Grade 3, n= 46, 48	Number Analyzed	46 participants	48 participants
		1 2.2%	1 2.1%
INI, Grade 4, n= 46, 48	Number Analyzed	46 participants	48 participants
		3 6.5%	2 4.2%
PI, Grade 1, n= 75, 74	Number Analyzed	75 participants	74 participants
		35 46.7%	25 33.8%
PI, Grade 2, n= 75, 74	Number Analyzed	75 participants	74 participants
		10 13.3%	23 31.1%
PI, Grade 3, n= 75, 74	Number Analyzed	75 participants	74 participants
		8 10.7%	9 12.2%
PI, Grade 4, n= 75, 74	Number Analyzed	75 participants	74 participants
		0 0.0%	4 5.4%

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 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Value at Day 1 was considered as Baseline. 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 DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time Frame	Up to 48 weeks

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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI; Grade 1; n= 131, 134	Number Analyzed	131 participants	134 participants
		5 3.8%	3 2.2%
NNRTI; Grade 2; n= 131, 134	Number Analyzed	131 participants	134 participants
		1 0.8%	1 0.7%
NNRTI; Grade 3; n= 131, 134	Number Analyzed	131 participants	134 participants
		1 0.8%	1 0.7%
NNRTI; Grade 4; n= 131, 134	Number Analyzed	131 participants	134 participants
		0 0.0%	1 0.7%
INI; Grade 1; n= 46, 48	Number Analyzed	46 participants	48 participants
		2 4.3%	2 4.2%
INI; Grade 2; n= 46, 48	Number Analyzed	46 participants	48 participants
		1 2.2%	0 0.0%
INI; Grade 3; n= 46, 48	Number Analyzed	46 participants	48 participants
		0 0.0%	0 0.0%
INI; Grade 4; n= 46, 48	Number Analyzed	46 participants	48 participants
		0 0.0%	0 0.0%
PI; Grade 1; n= 75, 74	Number Analyzed	75 participants	74 participants
		4 5.3%	6 8.1%
PI; Grade 2; n= 75, 74	Number Analyzed	75 participants	74 participants
		1 1.3%	1 1.4%
PI; Grade 3; n= 75, 74	Number Analyzed	75 participants	74 participants
		2 2.7%	0 0.0%
PI; Grade 4; n= 75, 74	Number Analyzed	75 participants	74 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	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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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	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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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), Week 24 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: mmol/mL
CHO, Week 24, overall, n=228, 223	Number Analyzed	228 participants	223 participants
		3.239 (18.1556)	2.375 (14.8357)
CHO, Week 48, overall, n=221, 218	Number Analyzed	221 participants	218 participants
		3.596 (18.7072)	2.472 (14.7202)
CHO, Week 24, NNRTI, n=0, 118	Number Analyzed	0 participants	118 participants
			3.383 (13.3685)
CHO, Week 48, NNRTI, n=0, 118	Number Analyzed	0 participants	118 participants
			4.099 (13.8992)
CHO, Week 24, INI, n=0, 44	Number Analyzed	0 participants	44 participants
			1.288 (14.8933)
CHO, Week 48, INI, n=0, 43	Number Analyzed	0 participants	43 participants
			0.524 (15.3143)
CHO, Week 24, PI, n=0, 61	Number Analyzed	0 participants	61 participants
			1.211 (17.3972)
CHO, Week 48, PI, n=0, 57	Number Analyzed	0 participants	57 participants
			0.575 (15.7475)
HDL CHO direct, Overall, Week 24, n=228, 223	Number Analyzed	228 participants	223 participants
		0.017 (18.7575)	-2.478 (16.6754)
HDL CHO direct, Overall, Week 48, n=221, 218	Number Analyzed	221 participants	218 participants
		3.975 (21.1039)	3.095 (18.8909)
HDL CHO direct, NNRTI, Week 24, n=0, 118	Number Analyzed	0 participants	118 participants
			0.062 (15.9300)
HDL CHO direct, NNRTI, Week 48, n=0, 118	Number Analyzed	0 participants	118 participants
			4.818 (16.2253)
HDL CHO direct, INI, Week 24, n=0, 44	Number Analyzed	0 participants	44 participants
			-4.968 (16.2973)
HDL CHO direct, INI, Week 48, n=0, 43	Number Analyzed	0 participants	43 participants
			0.539 (22.6496)
HDL CHO direct, PI, Week 24, n=0, 61	Number Analyzed	0 participants	61 participants
			-5.594 (17.7923)
HDL CHO direct, PI, Week 48, n=0, 57	Number Analyzed	0 participants	57 participants
			1.457 (20.8346)
LDL CHO calculation, Overall, Week 24, n=224, 217	Number Analyzed	224 participants	217 participants
		11.504 (36.9087)	6.196 (24.0104)
LDL CHO calculation, Overall, Week 48, n=215, 211	Number Analyzed	215 participants	211 participants
		8.257 (33.0405)	3.258 (22.3644)
LDL CHO calculation, NNRTI, Week 24, n=0, 116	Number Analyzed	0 participants	116 participants
			6.816 (20.9081)
LDL CHO calculation, NNRTI, Week 48, n=0, 114	Number Analyzed	0 participants	114 participants
			4.920 (20.9300)
LDL CHO calculation, INI, Week 24, n=0, 44	Number Analyzed	0 participants	44 participants
			6.355 (24.1747)
LDL CHO calculation, INI, Week 48, n=0, 43	Number Analyzed	0 participants	43 participants
			3.490 (23.3198)
LDL CHO calculation, PI, Week 24, n=0, 57	Number Analyzed	0 participants	57 participants
			4.813 (29.5705)
LDL CHO calculation, PI, Week 48, n=0, 54	Number Analyzed	0 participants	54 participants
			-0.434 (24.4332)
Triglycerides, Overall, Week 24, n=228, 223	Number Analyzed	228 participants	223 participants
		0.096 (55.6357)	8.649 (48.8249)
Triglycerides, Overall, Week 48, n=221, 218	Number Analyzed	221 participants	218 participants
		3.605 (54.4914)	11.068 (54.6321)
Triglycerides, NNRTI, Week 24, n=0, 118	Number Analyzed	0 participants	118 participants
			6.867 (44.8605)
Triglycerides, NNRTI, Week 48, n=0, 118	Number Analyzed	0 participants	118 participants
			10.215 (58.4055)
Triglycerides, INI, Week 24, n=0, 44	Number Analyzed	0 participants	44 participants
			8.386 (54.1265)
Triglycerides, INI, Week 48, n=0, 43	Number Analyzed	0 participants	43 participants
			4.644 (48.8708)
Triglycerides, PI, Week 24, n=0, 61	Number Analyzed	0 participants	61 participants
			12.283 (52.6943)
Triglycerides, PI, Week 48, n=0, 57	Number Analyzed	0 participants	57 participants
			17.681 (50.6912)

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	Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses 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 participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. 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. Day 1 was considered as Baseline value.
Time Frame	Baseline (Day 1), Week 4, Week 24 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 inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. 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		252	256
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Symptom count, Week 4, n=212, 197	Number Analyzed	212 participants	197 participants
		-1.6 (4.19)	0.2 (4.26)
Symptom count, Week 24, n=214, 201	Number Analyzed	214 participants	201 participants
		-0.8 (5.19)	-0.2 (4.06)
Symptom count, Week 48, n=214, 201	Number Analyzed	214 participants	201 participants
		-0.4 (5.52)	0.0 (4.49)
Symptom Bother Score, Week 4, n=212, 197	Number Analyzed	212 participants	197 participants
		-3.0 (7.25)	-0.8 (7.82)
Symptom Bother Score, Week 24, n=214, 201	Number Analyzed	214 participants	201 participants
		-1.7 (8.47)	-1.3 (8.53)
Symptom Bother Score, Week 48, n=214, 201	Number Analyzed	214 participants	201 participants
		-1.4 (8.32)	-0.7 (9.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.940
	Comments	P-value for interaction between treatment group and Baseline symptom bother score (Week 4)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	P value to assess difference between treatment groups (Week 4)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.924
	Confidence Interval	(2-Sided) 95%; -4.260 to -1.588
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	P-value for interaction between treatment group and Baseline symptom bother score (Week 24)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.110
	Comments	P value to assess difference between treatment groups (Week 24)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.192
	Confidence Interval	(2-Sided) 95%; -2.656 to 0.271
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.048
	Comments	P-value for interaction between treatment group and Baseline symptom bother score (Week 48)
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.038
	Comments	P value to assess difference between treatment groups (Week 48)
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.569
	Confidence Interval	(2-Sided) 95%; -3.048 to -0.090
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

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