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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02429791
• Collaborator: Janssen Pharmaceuticals (Industry), GlaxoSmithKline (Industry)
• Enrollment: 510
• Locations: 65
• Arms: 2
• Anticipated Duration (Months): 86.5
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: CAR	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 510 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed
• Actual Study Start Date: Apr 14, 2015
• Actual Primary Completion Date: Sep 16, 2016
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Participants receiving CAR Participants will receive CAR from Day 1 to Week 52 (Early Switch Phase), and eligible participants will switch to DTG 50 milligrams (mg) + RPV 25 mg once daily from Week 52 to 148 (Late Switch Phase).	Drug: CAR; CAR will include following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI
Experimental: Participants receiving DTG 50 mg + RPV 25 mg Participants will receive DTG 50 mg + RPV 25 mg once daily from Day 1 through Week 148 (Early and Late Switch Phase).	Drug: DTG 50 mg; Participants will take one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet will contain 52.62 mg dolutegravir sodium salt, which is equivalent to 50 mg dolutegravir free acid.; Drug: RPV 25 mg; Participants will take one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet will contain 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of RPV.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm [Week 48]

   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.

Secondary Outcome Measures

1. Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48 [Baseline (Day 1), Weeks 24 and 48]

   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.

2. Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm [Week 24]

   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.

3. 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) [Up to Week 52]

   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.

4. Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Over 48 Weeks [Up to 48 weeks]

   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.

5. Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks [Up to 48 weeks]

   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.

6. Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48 [Baseline (Day 1) and Week 48]

   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.

7. Mean Change From Baseline in Cystatin C at Week 48 [Baseline (Day 1) and Week 48]

   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.

8. Mean Change From Baseline in D-Dimer at Week 48 [Baseline (Day 1) and Week 48]

   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.

9. Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48 [Baseline (Day 1) and Week 48]

   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.

10. Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48 [Baseline (Day 1) and Week 48]

    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.

11. Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 [Baseline (Day 1) and Week 48]

    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.

12. Mean Change From Baseline in Urine Phosphate at Week 48 [Baseline (Day 1) and Week 48]

    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.

13. Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 [Baseline (Day 1) and Week 48]

    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.

14. Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48 [Baseline (Day 1) and Week 48]

    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.

15. 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 [Baseline (Day 1) and Week 48]

    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.

16. Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48 [Baseline (Day 1) and Week 48]

    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.

17. Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 [Baseline (Day 1) and Week 48]

    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.

18. Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 [Baseline (Day 1), Week 24 and Week 48]

    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.

19. Number of Participants With Genotypic Resistance- Early Switch Phase [Up to Week 48]

    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.

20. Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase [Up to Week 148]

    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.

21. Number of Participants With Genotypic Resistance-CAR Late Switch Group Through Late Switch Phase [Post-LS Baseline (Week 52) up to Week 148]

    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.

22. Number of Participants With Phenotypic Resistance-Early Switch Phase [Up to Week 48]

    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.

23. Number of Participants With Phenotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase [Up to Week 148]

    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.

24. Number of Participants With Phenotypic Resistance-CAR Late Switch Group Through Late Switch Phase [Post-LS Baseline (Week 52) up to Week 148]

    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.

25. 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 [Pre-dose at Week 4, 24, 48, 56, 76 and 100]

    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).

26. 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 [Pre-dose at Weeks 56, 76 and 100]

    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.

27. 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 [Pre-dose at Week 2, 4 and 8]

    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.

28. Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class [Week 48]

    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.

29. Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class [Baseline (Day 1) and Week 48]

    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.

30. 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 [Up to 48 weeks]

    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.

31. Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class [Up to 48 weeks]

    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.

32. Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class [Up to 48 weeks]

    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.

33. Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class [Up to Week 48]

    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.

34. Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class [Up to Week 48]

    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.

35. Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class [Baseline (Day 1), Week 24 and Week 48]

    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.

36. Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase [Baseline (Day 1), Week 4, Week 24 and Week 48]

    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.

37. 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 [Baseline (Day 1), Week 56, Week 76, Week 100 and Week 148]

    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). 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.

38. Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase [LS Baseline (Week 48), Week 56, Week 76, Week 100 and Week 148]

    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). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. Value at Week 48 was considered as LS Baseline value.

39. Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase [Baseline (Day 1), Week 4, Week 24 and Week 48]

    HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.

40. Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Early Switch Group Through Early and Late Switch Phase [Baseline (Day 1), Week 56, Week 76, Week 100 and Week 148]

    HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.

41. Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase [LS Baseline (Week 48), Week 56, Week 76, Week 100 and Week 148]

    HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Week 48 was considered as LS Baseline value. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.

Other Outcome Measures

1. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Early Switch Group Through Early and Late Switch Phase [Weeks 100 and 148]

   Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. 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.

2. Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase [Baseline (Day 1), Weeks 100 and 148]

   Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.

3. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Late Switch Group Through Late Switch Phase [Weeks 100 and 148]

   Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. 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.

4. Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Late Switch Group Through Late Switch Phase [LS Baseline (Week 48), Weeks 100 and 148]

   Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants must be able to understand and comply with protocol requirements, instructions, and restrictions.

• Participants must be likely to complete the study as planned.

• Participants must be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.).

• HIV-1 infected men or women of >=18 years of age.

• Must be on uninterrupted current regimen (either the initial or second combination antiretroviral therapy [cART] regimen) for at least 6 months prior to screening; Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification. Acceptable stable cART regimens prior to screening include 2 NRTIs plus INI (either the initial or second cART regimen), or an NNRTI (either the initial or second cART regimen), or a Boosted PI (or atazanavir unboosted) (either the initial or second PI-based cART regimen).

• Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening;

• Plasma HIV-1 RNA <50 c/mL at Screening;

• A female may be eligible to enter and participate in the study if she is of : Non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, Child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study medications and completion of the Follow-up visit; Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion); Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study and this male is the sole partner for that participant; The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination, and/or semen analysis, or medical history interview provided by her or her partner; Approved hormonal contraception for participants randomly assigned to DTG

• RPV arm (and for participants randomly assigned to CAR following switch to DTG + RPV at Week 52) or approved hormonal contraception plus a barrier method for participants assigned to CAR through Week 52; Approved hormonal contraception includes: Combined estrogen and progestogen oral contraceptive, Contraceptive subdermal implant, Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches. Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must be used consistently, in accordance with the approved product label during treatment with study drug and for at least 2 weeks after discontinuation of study drug and completion of the Follow-Up Visit. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Note: these contraceptive requirements do not apply to females of reproductive potential with same sex partners only, when this is their preferred and usual lifestyle. All participants participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.

• Participants who are willing and able to understand requirements of study participation and provide signed and dated written informed consent prior to screening.

• For participants enrolled in France: participants will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

Exclusionary Criteria prior to screening or Day 1:

• Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement >=50 c/mL.

• Within the 6 to 12 month window prior to screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL.

• Within the 6 to 12 month window prior to screening and after confirmed suppression to <50 c/mL, 2 or more plasma HIV-1 RNA measurements >=50 c/mL.

• Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.

• Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=400 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).

Exclusionary medical conditions:

• Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.

• Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions include cutaneous Kaposi's sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of <200 cells per cubic millimeter (cells/mm^3).

• Participants with severe hepatic impairment (Class C) as determined by Child-Pugh Classification.

• Unstable liver disease (as defined by the presence of any of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg are excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb are excluded. Note: Participant positive for anti-HBc (negative HBsAg status) and positive for HBsAb are immune to HBV and are not excluded.

• Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period.

• History or presence of allergy to the study drugs or their components or drugs of their class;

• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization;

• Participants who in the investigator's judgment pose a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk;

• Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participants;

• Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication;

Exclusionary Treatments prior to Screening or Day 1:

• Use of medications which are associated with Torsades de Pointes.

• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.

• Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses.

• Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.

• Participants who are currently participating or are anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization (NOTE: Participants who are already enrolled into another interventional study at time of screening may be eligible after consultation with the GlaxoSmithKline study team prior to randomization. Considerations include participant's ability to attend all visits on schedule, and possible drug and study procedure compatibility).

• A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART.

• Current or prior history of etravirine (ETR) use.

• Current use of tipranavir/ritonavir or fosamprenavir/ritonavir.

• Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease DTG or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose.

Exclusionary Laboratory Values or Clinical Assessments at Screening:

• Evidence of viral resistance based on the presence of any resistance associated major PI, INI, NRTI, or NNRTI mutation and integrase (IN) resistance associated substitution R263K in any available prior resistance genotype assay results. Note: Prior genotypic resistance testing is not required but if available it must be provided to GlaxoSmithKline, after screening and before randomization, to provide direct evidence of no pre-existing exclusionary resistance mutations. You must wait for the study virologists to confirm the lack of exclusionary resistance mutations, which will be provided before the screening window closes.

• Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.

• Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.

• Alanine aminotransferase (ALT) >=5 × upper limit of normal (ULN), or ALT >=3 × ULN and bilirubin >=1.5 × ULN (with >35% direct bilirubin).

• Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Long Beach	California	United States	90813
2	GSK Investigational Site	Los Angeles	California	United States	90019
3	GSK Investigational Site	Los Angeles	California	United States	90069
4	GSK Investigational Site	San Francisco	California	United States	94115
5	GSK Investigational Site	Washington	District of Columbia	United States	20009
6	GSK Investigational Site	Fort Pierce	Florida	United States	34982
7	GSK Investigational Site	Orlando	Florida	United States	32803
8	GSK Investigational Site	Savannah	Georgia	United States	31401
9	GSK Investigational Site	Saint Louis	Missouri	United States	63108
10	GSK Investigational Site	Camden	New Jersey	United States	08103
11	GSK Investigational Site	Dallas	Texas	United States	75246
12	GSK Investigational Site	Houston	Texas	United States	77098
13	GSK Investigational Site	Lynchburg	Virginia	United States	24501
14	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1425AWK
15	GSK Investigational Site	Darlinghurst	New South Wales	Australia	2010
16	GSK Investigational Site	Prahran	Victoria	Australia	3181
17	GSK Investigational Site	Antwerpen		Belgium	2000
18	GSK Investigational Site	Brussels		Belgium	1000
19	GSK Investigational Site	Gent		Belgium	9000
20	GSK Investigational Site	Liege		Belgium	4000
21	GSK Investigational Site	Vancouver	British Columbia	Canada	V6Z 2C7
22	GSK Investigational Site	Victoria	British Columbia	Canada	V8W 1M8
23	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 8L6
24	GSK Investigational Site	Toronto	Ontario	Canada	M5B 1W8
25	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2N2
26	GSK Investigational Site	Québec		Canada	G1V 4G2
27	GSK Investigational Site	Garches		France	92380
28	GSK Investigational Site	Lyon Cedex 03		France	69437
29	GSK Investigational Site	Paris Cedex 12		France	75571
30	GSK Investigational Site	Paris		France	75013
31	GSK Investigational Site	Paris		France	75018
32	GSK Investigational Site	Muenchen	Bayern	Germany	80336
33	GSK Investigational Site	Frankfurt	Hessen	Germany	60590
34	GSK Investigational Site	Frankfurt	Hessen	Germany	60596
35	GSK Investigational Site	Hamburg		Germany	20099
36	GSK Investigational Site	Hamburg		Germany	20146
37	GSK Investigational Site	Milano	Lombardia	Italy	20127
38	GSK Investigational Site	Milano	Lombardia	Italy	20142
39	GSK Investigational Site	Brescia		Italy	25123
40	GSK Investigational Site	Rotterdam		Netherlands	3015 CE
41	GSK Investigational Site	Rotterdam		Netherlands	3079 DZ
42	GSK Investigational Site	Kazan		Russian Federation	420061
43	GSK Investigational Site	Moscow		Russian Federation	105275
44	GSK Investigational Site	Orel		Russian Federation	302040
45	GSK Investigational Site	Smolensk		Russian Federation	214006
46	GSK Investigational Site	St. Petersburg		Russian Federation	196645
47	GSK Investigational Site	Alcala de Henares		Spain	28805
48	GSK Investigational Site	Barcelona		Spain	08003
49	GSK Investigational Site	Elche (Alicante)		Spain	03203
50	GSK Investigational Site	Granada		Spain	18016
51	GSK Investigational Site	Huelva		Spain	21080
52	GSK Investigational Site	Madrid		Spain	28034
53	GSK Investigational Site	Madrid		Spain	28040
54	GSK Investigational Site	Malaga		Spain	29020
55	GSK Investigational Site	Marbella		Spain	29600
56	GSK Investigational Site	Palma de Mallorca		Spain	07010
57	GSK Investigational Site	Palma de Mallorca		Spain	07198
58	GSK Investigational Site	Sevilla		Spain	41013
59	GSK Investigational Site	Sevilla		Spain	41041
60	GSK Investigational Site	Valencia		Spain	46015
61	GSK Investigational Site	Kaohsiung		Taiwan	813
62	GSK Investigational Site	Taipei		Taiwan	100
63	GSK Investigational Site	Taipei		Taiwan	11217
64	GSK Investigational Site	London		United Kingdom	E1 1BB
65	GSK Investigational Site	Manchester		United Kingdom	M8 5RB

Sponsors and Collaborators

• ViiV Healthcare
• Janssen Pharmaceuticals
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

• Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum in: Lancet. 2018 Feb 1;:.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02429791
• Other Study ID Numbers: 201636; 2014-005147-40
• First Posted: Apr 29, 2015
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by ViiV Healthcare: two-drug regimen; virologically-suppressed; dolutegravir plus rilpivirine; integrase inhibitor; protease inhibitor; NNRTI-sparing; non-nucleoside reverse transcriptase inhibitor; HIV; nucleoside reverse transcriptase inhibitors
• Additional relevant MeSH terms: HIV Infections

Study Results

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 Detail	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
Period Title: Early Switch Phase (Up to Week 52)
STARTED	239	238
COMPLETED	214	210
NOT COMPLETED	25	28

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 Participants	252	256	508
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.6 (10.93)	43.6 (10.76)	43.6 (10.84)
Sex: Female, Male (Count of Participants)
Female	58 23%	51 19.9%	109 21.5%
Male	194 77%	205 80.1%	399 78.5%
Race/Ethnicity, Customized (Count of 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%
Native Hawaiian or other Pacific Islander	1 0.4%	0 0%	1 0.2%
White	198 78.6%	188 73.4%	386 76%
American Indian or Alaska Native and white	0 0%	1 0.4%	1 0.2%
African American/African H. and Asian	1 0.4%	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.
Measure Participants	252	256
Number [Percentage of participants]	95 37.7%	96 37.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -4.3 to 3.0
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	252	256
Week 24, n=247, 249	16.2 (150.34)	47.4 (179.68)
Week 48, n=239, 245	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.
Measure Participants	252	256
Number [Percentage of participants]	98 38.9%	96 37.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.9 to 4.0
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	252	256
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.
Measure Participants	252	256
Grade 1	95 37.7%	78 30.5%
Grade 2	61 24.2%	86 33.6%
Grade 3	22 8.7%	23 9%
Grade 4	5 2%	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.
Measure Participants	252	256
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%	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.
Measure Participants	234	243
Mean (Standard Deviation) [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.
Measure Participants	237	245
Mean (Standard Deviation) [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.
Measure Participants	224	238
Mean (Standard Deviation) [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.
Measure Participants	252	256
FABP, n=233, 242	-2.79 (3.007)	-1.93 (2.150)
Soluble CD14, n=234, 242	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.
Measure Participants	252	256
Soluble CD163, n=232, 241	50.18 (188.772)	54.26 (238.900)
Oxidized LDL, n=234, 242	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.
Measure Participants	252	256
RBP, n=235, 243	-0.13 (1.023)	0.03 (0.974)
Serum creatinine, n=238, 243	0.087 (0.1074)	0.011 (0.0876)
Glucose, n=227, 227	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.
Measure Participants	218	224
Mean (Standard Deviation) [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.
Measure Participants	252	256
Blood B2M, n=233, 241	-15.1452 (44.55903)	-4.5995 (38.90474)
Blood 25 hydroxy-vitamin D, n=235, 244	-13.9 (22.76)	-8.2 (24.43)
Urine B2M, n=89, 96	-128.2045 (726.38825)	39.8394 (253.43025)
Urine RBP, n=221, 231	-8.8395 (28.83977)	-0.5851 (27.56405)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.958
	Confidence Interval	(2-Sided) 95%; 0.888 to 1.034
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Superiority
	Comments
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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.902
	Confidence Interval	(2-Sided) 95%; 0.793 to 1.025
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Superiority
	Comments
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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.847
	Confidence Interval	(2-Sided) 95%; 0.763 to 0.942
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	252	256
Urine albumin/creatinine ratio, n=166, 171	-1.19 (3.916)	-2.59 (28.878)
urine protein/creatinine ratio, n=176, 182	-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.
Measure Participants	252	256
Bone-specific alkaline phosphatase, n=234, 244	-2.89 (4.024)	0.90 (4.129)
Procollagen type 1 N-propeptide, n=234, 242	-9.1 (20.34)	-1.4 (18.95)
Osteocalcin, n=233, 242	-4.40 (7.605)	-0.68 (6.579)
Type I Collagen C-Telopeptides, n=234, 241	-0.18 (0.307)	-0.04 (1.160)
sVCAM, n=234, 243	-2.21 (1291.994)	89.07 (1239.465)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.724
	Confidence Interval	(2-Sided) 95%; 0.679 to 0.772
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.825
	Confidence Interval	(2-Sided) 95%; 0.742 to 0.918
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.810
	Confidence Interval	(2-Sided) 95%; 0.742 to 0.884
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (procollagen type 1-N-propeptide)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.817
	Confidence Interval	(2-Sided) 95%; 0.774 to 0.863
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P-value for interaction between treatment group and Baseline third agent (osteocalcin)
	Method	ANCOVA
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (osteocalcin - NNRTI)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.881
	Confidence Interval	(2-Sided) 95%; 0.823 to 0.943
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P value to assess difference between treatment groups (osteocalcin - INI)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.829
	Confidence Interval	(2-Sided) 95%; 0.740 to 0.930
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (osteocalcin - PI)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.691
	Confidence Interval	(2-Sided) 95%; 0.628 to 0.759
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.804
	Confidence Interval	(2-Sided) 95%; 0.742 to 0.872
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	233	243
Mean (Standard Deviation) [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.
Measure Participants	229	237
Mean (Standard Deviation) [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.
Measure Participants	252	256
Total cholesterol, Week 24, n=228, 223	0.076 (0.8398)	0.061 (0.7368)
Total cholesterol, Week 48, n=221, 218	0.089 (0.8488)	0.064 (0.7197)
LDL cholesterol calculation, Week 24, n=224, 217	0.165 (0.7065)	0.103 (0.6503)
LDL cholesterol calculation, Week 48, n=215, 211	0.108 (0.7178)	0.029 (0.6134)
HDL cholesterol direct, Week 24, n=228, 223	-0.030 (0.2601)	-0.044 (0.2394)
HDL cholesterol direct, Week 48, n=221, 218	0.023 (0.2757)	0.018 (0.2722)
Triglycerides, Week 24, n=228, 223	-0.154 (0.7324)	-0.001 (0.7712)
Triglycerides, Week 48, n=221, 218	-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.
Measure Participants	1	1
NNRTI, RPV, Susceptible	1 0.4%	NA NaN
NNRTI, RPV, Potential low-level resistance	0 0%	NA NaN
NNRTI, RPV, Low-level resistance	0 0%	NA NaN
NNRTI, RPV, Intermediate resistance	0 0%	NA NaN
NNRTI, RPV, High-level resistance	0 0%	NA NaN
INI, DTG, Susceptible	1 0.4%	NA NaN
INI, DTG, Potential low-level resistance	0 0%	NA NaN
INI, DTG, Low-level resistance	0 0%	NA NaN
INI, DTG, Intermediate resistance	0 0%	NA NaN
INI, DTG, High-level resistance	0 0%	NA NaN
NRTI, FTC, Susceptible	NA NaN	1 0.4%
NRTI, FTC, Potential low-level resistance	NA NaN	0 0%
NRTI, FTC, Low-level resistance	NA NaN	0 0%
NRTI, FTC, Intermediate resistance	NA NaN	0 0%
NRTI, FTC, High-level resistance	NA NaN	0 0%
NRTI, TDF, Susceptible	NA NaN	1 0.4%
NRTI, TDF, Potential low-level resistance	NA NaN	0 0%
NRTI, TDF, Low-level resistance	NA NaN	0 0%
NRTI, TDF, Intermediate resistance	NA NaN	0 0%
NRTI, TDF, High-level resistance	NA NaN	0 0%
PI, DRV/r, Susceptible	NA NaN	1 0.4%
PI, DRV/r, Potential low-level resistance	NA NaN	0 0%
PI, DRV/r, Low-level resistance	NA NaN	0 0%
PI, DRV/r, Intermediate resistance	NA NaN	0 0%
PI, DRV/r, High-level resistance	NA NaN	0 0%

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.
Measure Participants	5
INI, DTG, Susceptible	5 2%
INI, DTG, Potential low-level resistance	0 0%
INI, DTG, Low-level resistance	0 0%
INI, DTG, Intermediate resistance	0 0%
INI, DTG, High-level resistance	0 0%
INI, EVG,Susceptible	4 1.6%
INI, EVG, Potential low-level resistance	1 0.4%
INI, EVG,Low-level resistance	0 0%
INI, EVG, Intermediate resistance	0 0%
INI, EVG, High-level resistance	0 0%
INI, RAL,Susceptible	4 1.6%
INI, RAL, Potential low-level resistance	1 0.4%
INI, RAL, Low-level resistance	0 0%
INI, RAL, Intermediate resistance	0 0%
INI, RAL, High-level resistance	0 0%
NNRTI, DLV, Susceptible	5 2%
NNRTI, DLV, Potential low-level resistance	0 0%
NNRTI,DLV, Low-level resistance	0 0%
NNRTI, DLV, Intermediate resistance	0 0%
NNRTI, DLV, High-level resistance	0 0%
NNRTI, EFV, Susceptible	3 1.2%
NNRTI, EFV, Potential low-level resistance	0 0%
NNRTI, EFV, Low-level resistance	0 0%
NNRTI, EFV, Intermediate resistance	1 0.4%
NNRTI, EFV, High-level resistance	1 0.4%
NNRTI, ETR, Susceptible	3 1.2%
NNRTI, ETR, Potential low-level resistance	1 0.4%
NNRTI, ETR, Low-level resistance	0 0%
NNRTI, ETR, Intermediate resistance	1 0.4%
NNRTI, ETR, High-level resistance	0 0%
NNRTI,NVP, Susceptible	3 1.2%
NNRTI,NVP, Potential low-level resistance	0 0%
NNRTI,NVP, Low-level resistance	0 0%
NNRTI,NVP, Intermediate resistance	0 0%
NNRTI, NVP, High-level resistance	2 0.8%
NNRTI, RPV, Susceptible	3 1.2%
NNRTI, RPV, Potential low-level resistance	0 0%
NNRTI, RPV, Low-level resistance	1 0.4%
NNRTI, RPV, Intermediate resistance	0 0%
NNRTI, RPV, High-level resistance	1 0.4%
NRTI, 3TC, Susceptible	5 2%
NRTI, 3TC, Potential low-level resistance	0 0%
NRTI, 3TC, Low-level resistance	0 0%
NRTI, 3TC, Intermediate resistance	0 0%
NRTI, 3TC, High-level resistance	0 0%
NRTI, ABC, Susceptible	5 2%
NRTI, ABC, Potential low-level resistance	0 0%
NRTI, ABC, Low-level resistance	0 0%
NRTI, ABC, Intermediate resistance	0 0%
NRTI, ABC, High-level resistance	0 0%
NRTI, FTC, Susceptible	5 2%
NRTI, FTC, Potential low-level resistance	0 0%
NRTI, FTC, Low-level resistance	0 0%
NRTI, FTC, Intermediate resistance	0 0%
NRTI, FTC, High-level resistance	0 0%
NRTI, TDF, Susceptible	5 2%
NRTI, TDF, Potential low-level resistance	0 0%
NRTI, TDF, Low-level resistance	0 0%
NRTI, TDF, Intermediate resistance	0 0%
NRTI, TDF, High-level resistance	0 0%
NRTI, ZDV, Susceptible	4 1.6%
NRTI, ZDV, Potential low-level resistance	1 0.4%
NRTI, ZDV, Low-level resistance	0 0%
NRTI, ZDV, Intermediate resistance	0 0%
NRTI, ZDV, High-level resistance	0 0%
NRTI, d4T, Susceptible	4 1.6%
NRTI, d4T, Potential low-level resistance	1 0.4%
NRTI, d4T, Low-level resistance	0 0%
NRTI, d4T, Intermediate resistance	0 0%
NRTI, d4T, High-level resistance	0 0%
NRTI, ddI, Susceptible	5 2%
NRTI, ddI, Potential low-level resistance	0 0%
NRTI, ddI, Low-level resistance	0 0%
NRTI, ddI, Intermediate resistance	0 0%
NRTI, ddI, High-level resistance	0 0%
PI, ATV/r, Susceptible	5 2%
PI, ATV/r, Potential low-level resistance	0 0%
PI, ATV/r, Low-level resistance	0 0%
PI, ATV/r, Intermediate resistance	0 0%
PI, ATV/r, High-level resistance	0 0%
PI, DRV/r, Susceptible	5 2%
PI, DRV/r, Potential low-level resistance	0 0%
PI, DRV/r, Low-level resistance	0 0%
PI, DRV/r, Intermediate resistance	0 0%
PI, DRV/r, High-level resistance	0 0%
PI, FPV/r, Susceptible	5 2%
PI, FPV/r, Potential low-level resistance	0 0%
PI, FPV/r, Low-level resistance	0 0%
PI, FPV/r, Intermediate resistance	0 0%
PI, FPV/r, High-level resistance	0 0%
PI, IDV/r, Susceptible	5 2%
PI, IDV/r, Potential low-level resistance	0 0%
PI, IDV/r, Low-level resistance	0 0%
PI, IDV/r, Intermediate resistance	0 0%
PI, IDV/r, High-level resistance	0 0%
PI, LPV/r, Susceptible	5 2%
PI, LPV/r, Potential low-level resistance	0 0%
PI, LPV/r, Low-level resistance	0 0%
PI, LPV/r, Intermediate resistance	0 0%
PI, LPV/r,High-level resistance	0 0%
PI, NFV, Susceptible	5 2%
PI, NFV, Potential low-level resistance	0 0%
PI, NFV, Low-level resistance	0 0%
PI, NFV, Intermediate resistance	0 0%
PI, NFV, High-level resistance	0 0%
PI, RTV, Susceptible	5 2%
PI, RTV, Potential low-level resistance	0 0%
PI, RTV, Low-level resistance	0 0%
PI, RTV, Intermediate resistance	0 0%
PI, RTV, High-level resistance	0 0%
PI, SQV/r, Susceptible	5 2%
PI, SQV/r, Potential low-level resistance	0 0%
PI, SQV/r, Low-level resistance	0 0%
PI, SQV/r, Intermediate resistance	0 0%
PI, SQV/r, High-level resistance	0 0%
PI, TPV/r, Susceptible	5 2%
PI, TPV/r, Potential low-level resistance	0 0%
PI, TPV/r, Low-level resistance	0 0%
PI, TPV/r, Intermediate resistance	0 0%
PI, TPV/r, High-level resistance	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.
Measure Participants	1
INI, DTG, Susceptible	1 0.4%
INI, DTG, Potential low-level resistance	0 0%
INI, DTG, Low-level resistance	0 0%
INI, DTG, Intermediate resistance	0 0%
INI, DTG, High-level resistance	0 0%
INI, EVG,Susceptible	1 0.4%
INI, EVG, Potential low-level resistance	0 0%
INI, EVG,Low-level resistance	0 0%
INI, EVG, Intermediate resistance	0 0%
INI, EVG, High-level resistance	0 0%
INI, RAL,Susceptible	1 0.4%
INI, RAL, Potential low-level resistance	0 0%
INI, RAL, Low-level resistance	0 0%
INI, RAL, Intermediate resistance	0 0%
INI, RAL, High-level resistance	0 0%
NNRTI, DLV, Susceptible	1 0.4%
NNRTI, DLV, Potential low-level resistance	0 0%
NNRTI,DLV, Low-level resistance	0 0%
NNRTI, DLV, Intermediate resistance	0 0%
NNRTI, DLV, High-level resistance	0 0%
NNRTI, EFV, Susceptible	0 0%
NNRTI, EFV, Potential low-level resistance	1 0.4%
NNRTI, EFV, Low-level resistance	0 0%
NNRTI, EFV, Intermediate resistance	0 0%
NNRTI, EFV, High-level resistance	0 0%
NNRTI, ETR, Susceptible	0 0%
NNRTI, ETR, Potential low-level resistance	1 0.4%
NNRTI, ETR, Low-level resistance	0 0%
NNRTI, ETR, Intermediate resistance	0 0%
NNRTI, ETR, High-level resistance	0 0%
NNRTI,NVP, Susceptible	0 0%
NNRTI,NVP, Potential low-level resistance	1 0.4%
NNRTI,NVP, Low-level resistance	0 0%
NNRTI,NVP, Intermediate resistance	0 0%
NNRTI, NVP, High-level resistance	0 0%
NNRTI, RPV, Susceptible	0 0%
NNRTI, RPV, Potential low-level resistance	1 0.4%
NNRTI, RPV, Low-level resistance	0 0%
NNRTI, RPV, Intermediate resistance	0 0%
NNRTI, RPV, High-level resistance	0 0%
NRTI, 3TC, Susceptible	1 0.4%
NRTI, 3TC, Potential low-level resistance	0 0%
NRTI, 3TC, Low-level resistance	0 0%
NRTI, 3TC, Intermediate resistance	0 0%
NRTI, 3TC, High-level resistance	0 0%
NRTI, ABC, Susceptible	1 0.4%
NRTI, ABC, Potential low-level resistance	0 0%
NRTI, ABC, Low-level resistance	0 0%
NRTI, ABC, Intermediate resistance	0 0%
NRTI, ABC, High-level resistance	0 0%
NRTI, FTC, Susceptible	1 0.4%
NRTI, FTC, Potential low-level resistance	0 0%
NRTI, FTC, Low-level resistance	0 0%
NRTI, FTC, Intermediate resistance	0 0%
NRTI, FTC, High-level resistance	0 0%
NRTI, TDF, Susceptible	1 0.4%
NRTI, TDF, Potential low-level resistance	0 0%
NRTI, TDF, Low-level resistance	0 0%
NRTI, TDF, Intermediate resistance	0 0%
NRTI, TDF, High-level resistance	0 0%
NRTI, ZDV, Susceptible	1 0.4%
NRTI, ZDV, Potential low-level resistance	0 0%
NRTI, ZDV, Low-level resistance	0 0%
NRTI, ZDV, Intermediate resistance	0 0%
NRTI, ZDV, High-level resistance	0 0%
NRTI, d4T, Susceptible	1 0.4%
NRTI, d4T, Potential low-level resistance	0 0%
NRTI, d4T, Low-level resistance	0 0%
NRTI, d4T, Intermediate resistance	0 0%
NRTI, d4T, High-level resistance	0 0%
NRTI, ddI, Susceptible	1 0.4%
NRTI, ddI, Potential low-level resistance	0 0%
NRTI, ddI, Low-level resistance	0 0%
NRTI, ddI, Intermediate resistance	0 0%
NRTI, ddI, High-level resistance	0 0%
PI, ATV/r, Susceptible	1 0.4%
PI, ATV/r, Potential low-level resistance	0 0%
PI, ATV/r, Low-level resistance	0 0%
PI, ATV/r, Intermediate resistance	0 0%
PI, ATV/r, High-level resistance	0 0%
PI, DRV/r, Susceptible	1 0.4%
PI, DRV/r, Potential low-level resistance	0 0%
PI, DRV/r, Low-level resistance	0 0%
PI, DRV/r, Intermediate resistance	0 0%
PI, DRV/r, High-level resistance	0 0%
PI, FPV/r, Susceptible	1 0.4%
PI, FPV/r, Potential low-level resistance	0 0%
PI, FPV/r, Low-level resistance	0 0%
PI, FPV/r, Intermediate resistance	0 0%
PI, FPV/r, High-level resistance	0 0%
PI, IDV/r, Susceptible	1 0.4%
PI, IDV/r, Potential low-level resistance	0 0%
PI, IDV/r, Low-level resistance	0 0%
PI, IDV/r, Intermediate resistance	0 0%
PI, IDV/r, High-level resistance	0 0%
PI, LPV/r, Susceptible	1 0.4%
PI, LPV/r, Potential low-level resistance	0 0%
PI, LPV/r, Low-level resistance	0 0%
PI, LPV/r, Intermediate resistance	0 0%
PI, LPV/r,High-level resistance	0 0%
PI, NFV, Susceptible	1 0.4%
PI, NFV, Potential low-level resistance	0 0%
PI, NFV, Low-level resistance	0 0%
PI, NFV, Intermediate resistance	0 0%
PI, NFV, High-level resistance	0 0%
PI, RTV, Susceptible	1 0.4%
PI, RTV, Potential low-level resistance	0 0%
PI, RTV, Low-level resistance	0 0%
PI, RTV, Intermediate resistance	0 0%
PI, RTV, High-level resistance	0 0%
PI, SQV/r, Susceptible	1 0.4%
PI, SQV/r, Potential low-level resistance	0 0%
PI, SQV/r, Low-level resistance	0 0%
PI, SQV/r, Intermediate resistance	0 0%
PI, SQV/r, High-level resistance	0 0%
PI, TPV/r, Susceptible	1 0.4%
PI, TPV/r, Potential low-level resistance	0 0%
PI, TPV/r, Low-level resistance	0 0%
PI, TPV/r, Intermediate resistance	0 0%
PI, TPV/r, High-level resistance	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.
Measure Participants	1	1
INI, DTG, Resistant	0 0%	0 0%
INI, DTG, Partially Sensitive	0 0%	0 0%
INI, DTG, Sensitive	1 0.4%	1 0.4%
INI, EVG, Resistant	0 0%	0 0%
INI, EVG, Sensitive	1 0.4%	1 0.4%
INI, RAL, Resistant	0 0%	0 0%
INI, RAL, Sensitive	1 0.4%	1 0.4%
NNRTI, DLV, Resistant	0 0%	0 0%
NNRTI, DLV, Sensitive	1 0.4%	1 0.4%
NNRTI, EFV, Resistant	0 0%	0 0%
NNRTI, EFV, Sensitive	1 0.4%	1 0.4%
NNRTI, ETR, Resistant	0 0%	0 0%
NNRTI, ETR, Partially Sensitive	0 0%	0 0%
NNRTI, ETR, Sensitive	1 0.4%	1 0.4%
NNRTI, NVP, Resistant	0 0%	0 0%
NNRTI, NVP, Sensitive	1 0.4%	1 0.4%
NNRTI, RPV, Resistant	0 0%	0 0%
NNRTI, RPV, Sensitive	1 0.4%	1 0.4%
NRTI, 3TC, Resistant	0 0%	0 0%
NRTI, 3TC, Sensitive	1 0.4%	1 0.4%
NRTI, ABC, Resistant	0 0%	0 0%
NRTI, ABC, Partially Sensitive	0 0%	0 0%
NRTI, ABC, Sensitive	1 0.4%	1 0.4%
NRTI,FTC, Resistant	0 0%	0 0%
NRTI, FTC, Sensitive	1 0.4%	1 0.4%
NRTI, TDF, Resistant	0 0%	0 0%
NRTI, TDF, Partially Sensitive	0 0%	0 0%
NRTI, TDF, Sensitive	1 0.4%	1 0.4%
NRTI, ZDV, Resistant	0 0%	0 0%
NRTI, ZDV, Sensitive	1 0.4%	1 0.4%
NRTI, d4T, Resistant	0 0%	0 0%
NRTI, d4T, Sensitive	1 0.4%	1 0.4%
NRTI, ddI, Resistant	0 0%	0 0%
NRTI, ddI, Partially Sensitive	0 0%	0 0%
NRTI, ddI, Sensitive	1 0.4%	1 0.4%
PI, ATV/r, Resistant	0 0%	0 0%
PI, ATV/r, Sensitive	1 0.4%	1 0.4%
PI, DRV/r, Resistant	0 0%	0 0%
PI, DRV/r, Partially Sensitive	0 0%	0 0%
PI, DRV/r, Sensitive	1 0.4%	1 0.4%
PI, FPV/r, Resistant	0 0%	0 0%
PI, FPV/r, Partially Sensitive	0 0%	0 0%
PI, FPV/r, Sensitive	1 0.4%	1 0.4%
PI, IDV/r, Resistant	0 0%	0 0%
PI, IDV/r, Sensitive	1 0.4%	1 0.4%
PI, LPV/r, Resistant	0 0%	0 0%
PI, LPV/r, Partially Sensitive	0 0%	0 0%
PI, LPV/r, Sensitive	1 0.4%	1 0.4%
PI, NFV, Resistant	0 0%	0 0%
PI, NFV, Sensitive	1 0.4%	1 0.4%
PI, RTV, Resistant	0 0%	0 0%
PI, RTV, Sensitive	1 0.4%	1 0.4%
PI, SQV/r, Resistant	0 0%	0 0%
PI, SQV/r, Partially Sensitive	0 0%	0 0%
PI, SQV/r, Sensitive	1 0.4%	1 0.4%
PI, TPV/r, Resistant	0 0%	0 0%
PI, TPV/r, Partially Sensitive	0 0%	0 0%
PI, TPV/r, Sensitive	1 0.4%	1 0.4%

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.
Measure Participants	5
INI, DTG, Resistant	0 0%
INI, DTG, Partially Sensitive	0 0%
INI, DTG, Sensitive	5 2%
INI, EVG, Resistant	0 0%
INI, EVG, Partially Sensitive	0 0%
INI, EVG, Sensitive	5 2%
INI, RAL, Resistant	0 0%
INI, RAL, Partially Sensitive	0 0%
INI, RAL, Sensitive	5 2%
NNRTI, DLV, Resistant	1 0.4%
NNRTI, DLV, Partially Sensitive	0 0%
NNRTI, DLV, Sensitive	4 1.6%
NNRTI, EFV, Resistant	1 0.4%
NNRTI, EFV, Partially Sensitive	0 0%
NNRTI, EFV, Sensitive	4 1.6%
NNRTI, ETR, Resistant	0 0%
NNRTI, ETR, Partially Sensitive	1 0.4%
NNRTI, ETR, Sensitive	4 1.6%
NNRTI, NVP, Resistant	1 0.4%
NNRTI, NVP, Partially Sensitive	0 0%
NNRTI, NVP, Sensitive	4 1.6%
NNRTI, RPV, Resistant	1 0.4%
NNRTI, RPV, Partially Sensitive	0 0%
NNRTI, RPV, Sensitive	4 1.6%
NRTI, 3TC, Resistant	0 0%
NRTI, 3TC, Partially Sensitive	0 0%
NRTI, 3TC, Sensitive	5 2%
NRTI, ABC, Resistant	0 0%
NRTI, ABC, Partially Sensitive	0 0%
NRTI, ABC, Sensitive	5 2%
NRTI, FTC, Resistant	0 0%
NRTI, FTC, Partially Sensitive	0 0%
NRTI, FTC, Sensitive	5 2%
NRTI, TDF, Resistant	0 0%
NRTI, TDF, Partially Sensitive	0 0%
NRTI, TDF, Sensitive	5 2%
NRTI, ZDV, Resistant	0 0%
NRTI, ZDV, Partially Sensitive	0 0%
NRTI, ZDV, Sensitive	5 2%
NRTI, d4T, Resistant	0 0%
NRTI, d4T, Partially Sensitive	0 0%
NRTI, d4T, Sensitive	5 2%
NRTI, ddI, Resistant	0 0%
NRTI, ddI, Partially Sensitive	0 0%
NRTI, ddI, Sensitive	5 2%
PI, ATV/r, Resistant	0 0%
PI, ATV/r, Partially Sensitive	0 0%
PI, ATV/r, Sensitive	5 2%
PI, DRV/r, Resistant	0 0%
PI, DRV/r, Partially Sensitive	0 0%
PI, DRV/r, Sensitive	5 2%
PI, FPV/r, Resistant	0 0%
PI, FPV/r, Partially Sensitive	0 0%
PI, FPV/r, Sensitive	5 2%
PI, IDV/r, Resistant	0 0%
PI, IDV/r, Partially Sensitive	0 0%
PI, IDV/r, Sensitive	5 2%
PI, LPV/r, Resistant	0 0%
PI, LPV/r, Partially Sensitive	0 0%
PI, LPV/r, Sensitive	5 2%
PI, NFV, Resistant	0 0%
PI, NFV, Partially Sensitive	0 0%
PI, NFV, Sensitive	5 2%
PI, RTV, Resistant	0 0%
PI, RTV, Partially Sensitive	0 0%
PI, RTV, Sensitive	5 2%
PI, SQV/r, Resistant	0 0%
PI, SQV/r, Partially Sensitive	0 0%
PI, SQV/r, Sensitive	5 2%
PI, TPV/r, Resistant	0 0%
PI, TPV/r, Partially Sensitive	0 0%
PI, TPV/r, Sensitive	5 2%

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.
Measure Participants	1
NNRTI, DLV, Resistant	1 0.4%
NNRTI, DLV, Partially Sensitive	0 0%
NNRTI, DLV, Sensitive	0 0%
NNRTI, EFV, Resistant	1 0.4%
NNRTI, EFV, Partially Sensitive	0 0%
NNRTI, EFV, Sensitive	0 0%
NNRTI, ETR, Resistant	0 0%
NNRTI, ETR, Partially Sensitive	0 0%
NNRTI, ETR, Sensitive	1 0.4%
NNRTI, NVP, Resistant	1 0.4%
NNRTI, NVP, Partially Sensitive	0 0%
NNRTI, NVP, Sensitive	0 0%
NNRTI, RPV, Resistant	0 0%
NNRTI, RPV, Partially Sensitive	0 0%
NNRTI, RPV, Sensitive	1 0.4%
NRTI, 3TC, Resistant	0 0%
NRTI, 3TC, Partially Sensitive	0 0%
NRTI, 3TC, Sensitive	1 0.4%
NRTI, ABC, Resistant	0 0%
NRTI, ABC, Partially Sensitive	0 0%
NRTI, ABC, Sensitive	1 0.4%
NRTI, FTC, Resistant	0 0%
NRTI, FTC, Partially Sensitive	0 0%
NRTI, FTC, Sensitive	1 0.4%
NRTI, TDF, Resistant	0 0%
NRTI, TDF, Partially Sensitive	0 0%
NRTI, TDF, Sensitive	1 0.4%
NRTI, ZDV, Resistant	0 0%
NRTI, ZDV, Partially Sensitive	0 0%
NRTI, ZDV, Sensitive	1 0.4%
NRTI, d4T, Resistant	0 0%
NRTI, d4T, Partially Sensitive	0 0%
NRTI, d4T, Sensitive	1 0.4%
NRTI, ddI, Resistant	0 0%
NRTI, ddI, Partially Sensitive	0 0%
NRTI, ddI, Sensitive	1 0.4%
PI, ATV/r, Resistant	0 0%
PI, ATV/r, Partially Sensitive	0 0%
PI, ATV/r, Sensitive	1 0.4%
PI, DRV/r, Resistant	0 0%
PI, DRV/r, Partially Sensitive	0 0%
PI, DRV/r, Sensitive	1 0.4%
PI, FPV/r, Resistant	0 0%
PI, FPV/r, Partially Sensitive	0 0%
PI, FPV/r, Sensitive	1 0.4%
PI, IDV/r, Resistant	0 0%
PI, IDV/r, Partially Sensitive	0 0%
PI, IDV/r, Sensitive	1 0.4%
PI, LPV/r, Resistant	0 0%
PI, LPV/r, Partially Sensitive	0 0%
PI, LPV/r, Sensitive	1 0.4%
PI, NFV, Resistant	0 0%
PI, NFV, Partially Sensitive	0 0%
PI, NFV, Sensitive	1 0.4%
PI, RTV, Resistant	0 0%
PI, RTV, Partially Sensitive	0 0%
PI, RTV, Sensitive	1 0.4%
PI, SQV/r, Resistant	0 0%
PI, SQV/r, Partially Sensitive	0 0%
PI, SQV/r, Sensitive	1 0.4%
PI, TPV/r, Resistant	0 0%
PI, TPV/r, Partially Sensitive	0 0%
PI, TPV/r, Sensitive	1 0.4%

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.
Measure Participants	243	243
Week 4, n=130, 130	1581.06 (1146.860)	92.05 (138.288)
Week 24, n=210, 210	1835.68 (1120.539)	87.88 (39.141)
Week 48, n=215, 211	1915.11 (1304.238)	95.18 (48.228)
Week 56, n=204, 204	1872.65 (1173.815)	95.38 (53.602)
Week 76, n=194,194	1711.83 (1092.143)	88.10 (42.250)
Week 100, n=203, 203	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.
Measure Participants	225	225
Week 56, n=198, 198	1738.55 (1329.931)	84.14 (47.290)
Week 76, n=192, 192	1800.39 (1162.370)	97.79 (52.532)
Week 100, n=192, 191	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.
Measure Participants	26	26
Week 2, n=16, 15	821.25 (574.607)	65.360 (31.2965)
Week 4, n=19, 19	994.00 (581.201)	67.374 (27.5663)
Week 8, n=19, 19	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.
Measure Participants	252	256
NNRTI, n=131, 134	95 37.7%	98 38.3%
INI, n=46, 48	98 38.9%	96 37.5%
PI, n=75, 74	95 37.7%	92 35.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -7.7 to 1.5
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -5.1 to 9.0
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; -5.3 to 10.8
	Parameter Dispersion	Type: Value:
	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.
Measure Participants	252	256
NNRTI, n=124, 130	47.9 (142.90)	25.0 (151.27)
INI, n=45, 46	19.9 (148.63)	39.9 (200.38)
PI, n=70, 69	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.
Measure Participants	252	256
Any AE, NNRTI, n=131, 134	102 40.5%	98 38.3%
Any AE, INI, n=46, 48	38 15.1%	34 13.3%
Any AE, PI, n=75, 74	60 23.8%	58 22.7%
NNRTI, Maximum toxicity Grade 1 AE, n=131, 134	69 27.4%	72 28.1%
NNRTI, Maximum toxicity Grade 2 AE, n=131, 134	27 10.7%	23 9%
NNRTI, Maximum toxicity Grade 3 AE, n=131, 134	5 2%	2 0.8%
NNRTI, Maximum toxicity Grade 4 AE, n=131, 134	1 0.4%	1 0.4%
INI, Maximum toxicity Grade 1 AE, n=46, 48	28 11.1%	20 7.8%
INI, Maximum toxicity Grade 2 AE, n=46, 48	7 2.8%	12 4.7%
INI, Maximum toxicity Grade 3 AE, n=46, 48	2 0.8%	2 0.8%
INI, Maximum toxicity Grade 4 AE, n=46, 48	1 0.4%	0 0%
PI, Maximum toxicity Grade 1 AE, n=75, 74	31 12.3%	30 11.7%
PI, Maximum toxicity Grade 2 AE, n=75, 74	23 9.1%	18 7%
PI, Maximum toxicity Grade 3 AE, n=75, 74	4 1.6%	9 3.5%
PI, Maximum toxicity Grade 4 AE, n=75, 74	2 0.8%	1 0.4%
AELD, NNRTI, n=131, 134	3 1.2%	0 0%
AELD, INI, n=46, 48	2 0.8%	0 0%
AELD, PI, n=75, 74	4 1.6%	2 0.8%

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.
Measure Participants	252	256
NNRTI, Grade 1, n=131, 134	47 18.7%	42 16.4%
NNRTI, Grade 2, n=131, 134	32 12.7%	48 18.8%
NNRTI, Grade 3, n=131, 134	13 5.2%	13 5.1%
NNRTI, Grade 4, n=131, 134	2 0.8%	3 1.2%
INI, Grade 1, n= 46, 48	13 5.2%	11 4.3%
INI, Grade 2, n= 46, 48	19 7.5%	15 5.9%
INI, Grade 3, n= 46, 48	1 0.4%	1 0.4%
INI, Grade 4, n= 46, 48	3 1.2%	2 0.8%
PI, Grade 1, n= 75, 74	35 13.9%	25 9.8%
PI, Grade 2, n= 75, 74	10 4%	23 9%
PI, Grade 3, n= 75, 74	8 3.2%	9 3.5%
PI, Grade 4, n= 75, 74	0 0%	4 1.6%

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.
Measure Participants	252	256
NNRTI; Grade 1; n= 131, 134	5 2%	3 1.2%
NNRTI; Grade 2; n= 131, 134	1 0.4%	1 0.4%
NNRTI; Grade 3; n= 131, 134	1 0.4%	1 0.4%
NNRTI; Grade 4; n= 131, 134	0 0%	1 0.4%
INI; Grade 1; n= 46, 48	2 0.8%	2 0.8%
INI; Grade 2; n= 46, 48	1 0.4%	0 0%
INI; Grade 3; n= 46, 48	0 0%	0 0%
INI; Grade 4; n= 46, 48	0 0%	0 0%
PI; Grade 1; n= 75, 74	4 1.6%	6 2.3%
PI; Grade 2; n= 75, 74	1 0.4%	1 0.4%
PI; Grade 3; n= 75, 74	2 0.8%	0 0%
PI; Grade 4; n= 75, 74	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.
Measure Participants	0	0

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.
Measure Participants	0	0

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.
Measure Participants	252	256
CHO, Week 24, overall, n=228, 223	3.239 (18.1556)	2.375 (14.8357)
CHO, Week 48, overall, n=221, 218	3.596 (18.7072)	2.472 (14.7202)
CHO, Week 24, NNRTI, n=0, 118	3.383 (13.3685)
CHO, Week 48, NNRTI, n=0, 118	4.099 (13.8992)
CHO, Week 24, INI, n=0, 44	1.288 (14.8933)
CHO, Week 48, INI, n=0, 43	0.524 (15.3143)
CHO, Week 24, PI, n=0, 61	1.211 (17.3972)
CHO, Week 48, PI, n=0, 57	0.575 (15.7475)
HDL CHO direct, Overall, Week 24, n=228, 223	0.017 (18.7575)	-2.478 (16.6754)
HDL CHO direct, Overall, Week 48, n=221, 218	3.975 (21.1039)	3.095 (18.8909)
HDL CHO direct, NNRTI, Week 24, n=0, 118	0.062 (15.9300)
HDL CHO direct, NNRTI, Week 48, n=0, 118	4.818 (16.2253)
HDL CHO direct, INI, Week 24, n=0, 44	-4.968 (16.2973)
HDL CHO direct, INI, Week 48, n=0, 43	0.539 (22.6496)
HDL CHO direct, PI, Week 24, n=0, 61	-5.594 (17.7923)
HDL CHO direct, PI, Week 48, n=0, 57	1.457 (20.8346)
LDL CHO calculation, Overall, Week 24, n=224, 217	11.504 (36.9087)	6.196 (24.0104)
LDL CHO calculation, Overall, Week 48, n=215, 211	8.257 (33.0405)	3.258 (22.3644)
LDL CHO calculation, NNRTI, Week 24, n=0, 116	6.816 (20.9081)
LDL CHO calculation, NNRTI, Week 48, n=0, 114	4.920 (20.9300)
LDL CHO calculation, INI, Week 24, n=0, 44	6.355 (24.1747)
LDL CHO calculation, INI, Week 48, n=0, 43	3.490 (23.3198)
LDL CHO calculation, PI, Week 24, n=0, 57	4.813 (29.5705)
LDL CHO calculation, PI, Week 48, n=0, 54	-0.434 (24.4332)
Triglycerides, Overall, Week 24, n=228, 223	0.096 (55.6357)	8.649 (48.8249)
Triglycerides, Overall, Week 48, n=221, 218	3.605 (54.4914)	11.068 (54.6321)
Triglycerides, NNRTI, Week 24, n=0, 118	6.867 (44.8605)
Triglycerides, NNRTI, Week 48, n=0, 118	10.215 (58.4055)
Triglycerides, INI, Week 24, n=0, 44	8.386 (54.1265)
Triglycerides, INI, Week 48, n=0, 43	4.644 (48.8708)
Triglycerides, PI, Week 24, n=0, 61	12.283 (52.6943)
Triglycerides, PI, Week 48, n=0, 57	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.
Measure Participants	252	256
Symptom count, Week 4, n=212, 197	-1.6 (4.19)	0.2 (4.26)
Symptom count, Week 24, n=214, 201	-0.8 (5.19)	-0.2 (4.06)
Symptom count, Week 48, n=214, 201	-0.4 (5.52)	0.0 (4.49)
Symptom Bother Score, Week 4, n=212, 197	-3.0 (7.25)	-0.8 (7.82)
Symptom Bother Score, Week 24, n=214, 201	-1.7 (8.47)	-1.3 (8.53)
Symptom Bother Score, Week 48, n=214, 201	-1.4 (8.32)	-0.7 (9.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	P value to assess difference between treatment groups (Week 4)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.924
	Confidence Interval	(2-Sided) 95%; -4.260 to -1.588
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.110
	Comments	P value to assess difference between treatment groups (Week 24)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.192
	Confidence Interval	(2-Sided) 95%; -2.656 to 0.271
	Parameter Dispersion	Type: Value:
	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
	Type of Statistical Test	Other
	Comments
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

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments	P value to assess difference between treatment groups (Week 48)
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.569
	Confidence Interval	(2-Sided) 95%; -3.048 to -0.090
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.

38. Secondary Outcome

Title	Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	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). 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 56, Week 76, Week 100 and Week 148

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	DTG + RPV
Arm/Group Description	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Measure Participants	214
Symptom count, Week 56	-0.9 (4.99)
Symptom count, Week 76	-0.2 (5.42)
Symptom count, Week 100	-0.4 (5.08)
Symptom count, Week 148	-0.6 (5.24)
Symptom Bother Score, Week 56	-1.6 (8.52)
Symptom Bother Score, Week 76	-0.9 (8.84)
Symptom Bother Score, Week 100	-0.8 (8.71)
Symptom Bother Score, Week 148	-0.8 (9.15)

39. Secondary Outcome

Title	Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase
Description	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). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. Value at Week 48 was considered as LS Baseline value.
Time Frame	LS Baseline (Week 48), Week 56, Week 76, Week 100 and Week 148

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Current Antiretroviral Regimen
Arm/Group Description	Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase 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.
Measure Participants	238
Symptom count, Week 56, n=186	-0.7 (4.38)
Symptom count, Week 76, n=188	0.1 (4.19)
Symptom count, Week 100, n=188	0.0 (4.35)
Symptom count, Week 148, n=188	0.4 (4.92)
Symptom Bother Score, Week 56, n=186	-2.0 (8.11)
Symptom Bother Score, Week 76, n=188	-0.4 (8.33)
Symptom Bother Score, Week 100, n=188	-0.4 (9.17)
Symptom Bother Score, Week 148, n=188	0.7 (9.57)

40. Secondary Outcome

Title	Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Description	HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. 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), 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.
Measure Participants	252	256
Total score, Week 4, n=250, 249	0.0	0.0
Total score, Week 24, n=252, 254	1.0	0.0
Total score, Week 48, n=252, 254	0.5	0.0
lifestyle/ease Sub-score, Week 4, n=248, 249	0.0	0.0
lifestyle/ease Sub-score, Week 24, n=252, 254	0.0	0.0
lifestyle/ease Sub-score, Week 48, n=252, 254	0.0	0.0
General Satisfaction/CS, Week 4, n=249, 249	0.0	0.0
General Satisfaction/CS, Week 24, n=252, 254	0.0	0.0
General Satisfaction/CS, Week 48, n=252, 254	0.0	0.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments	P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments	P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	DTG + RPV, Current Antiretroviral Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.099
	Comments	P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)
	Method	Wilcoxon rank sum test
	Comments

41. Secondary Outcome

Title	Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. 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), Week 56, Week 76, Week 100 and Week 148

Outcome Measure Data

Analysis Population Description

ITT-E 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.
Measure Participants	252
Total score, Week 56	0.0
Total score, Week 76	0.5
Total score, Week 100	0.0
Total score, Week 148	1.0
Lifestyle/ease Sub-score, Week 56	0.0
Lifestyle/ease Sub-score, Week 76	0.0
Lifestyle/ease Sub-score, Week 100	0.0
Lifestyle/ease Sub-score, Week 148	0.0
General Satisfaction/CS, Week 56	0.0
General Satisfaction/CS, Week 76	0.0
General Satisfaction/CS, Week 100	0.0
General Satisfaction/CS, Week 148	0.0

42. Secondary Outcome

Title	Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase
Description	HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Week 48 was considered as LS Baseline value. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Time Frame	LS Baseline (Week 48), Week 56, Week 76, Week 100 and Week 148

Outcome Measure Data

Analysis Population Description

LS ITT-E Population. Only those participants with data available at the specified time points 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.
Measure Participants	236
Total score, Week 56	0.0
Total score, Week 76	0.0
Total score, Week 100	0.0
Total score, Week 148	0.0
Lifestyle/ease Sub-score, Week 56	0.0
Lifestyle/ease Sub-score, Week 76	0.0
Lifestyle/ease Sub-score, Week 100	0.0
Lifestyle/ease Sub-score, Week 148	0.0
General Satisfaction/CS, Week 56	0.0
General Satisfaction/CS, Week 76	0.0
General Satisfaction/CS, Week 100	0.0
General Satisfaction/CS, Week 148	0.0

43. Other Pre-specified Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. 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.
Time Frame	Weeks 100 and 148

Outcome Measure Data

Analysis Population Description

ITT-E 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.
Measure Participants	252
Week 100	88 34.9%
Week 148	85 33.7%

44. Other Pre-specified Outcome

Title	Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Description	Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time Frame	Baseline (Day 1), Weeks 100 and 148

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	DTG + RPV
Arm/Group Description	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Measure Participants	252
Week 100; n=224	25.1 (156.31)
Week 148; n=212	39.9 (174.40)

45. Other Pre-specified Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Late Switch Group Through Late Switch Phase
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. 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.
Time Frame	Weeks 100 and 148

Outcome Measure Data

Analysis Population Description

LS ITT-E Population

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.
Measure Participants	238
Week 100	90 35.7%
Week 148	87 34.5%

46. Other Pre-specified Outcome

Title	Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Late Switch Group Through Late Switch Phase
Description	Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Time Frame	LS Baseline (Week 48), Weeks 100 and 148

Outcome Measure Data

Analysis Population Description

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

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.
Measure Participants	238
Week 100; n=217	-3.3 (180.82)
Week 148; n=207	3.7 (205.29)

Adverse Events

Time Frame	On-treatment SAEs and non-serious AEs were collected from the start of the study treatment up to 148 weeks. Data presented for DTG+RPV (Early Switch) and CAR (Early Switch) represent safety events during Early switch phase (Up to Week 52). The safety data presented for DTG+RPV (Early+Late Switch) arm represents safety events up to Week 148 and that for CAR (Late Switch) represents safety events from Week 52 to Week 148.
Adverse Event Reporting Description	On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm).
Arm/Group Title	DTG + RPV (Early Switch)		CAR (Early Switch)		DTG + RPV (Early + Late Switch)		CAR (Late Switch)
Arm/Group Description	Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.		Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.		Participants received DTG 50 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.		At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA <50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
All Cause Mortality
	DTG + RPV (Early Switch)		CAR (Early Switch)		DTG + RPV (Early + Late Switch)		CAR (Late Switch)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/252 (0%)		1/256 (0.4%)		1/252 (0.4%)		0/238 (0%)
Serious Adverse Events
	DTG + RPV (Early Switch)		CAR (Early Switch)		DTG + RPV (Early + Late Switch)		CAR (Late Switch)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/252 (4%)		13/256 (5.1%)		34/252 (13.5%)		22/238 (9.2%)
Cardiac disorders
Acute myocardial infarction	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Pericarditis	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Wolff-Parkinson-White syndrome	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Ear and labyrinth disorders
Vertigo	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Endocrine disorders
Thyroid mass	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Gastrointestinal disorders
Pancreatitis acute	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Anal fistula	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Duodenal ulcer haemorrhage	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Gastric ulcer haemorrhage	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Gastrooesophageal reflux disease	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Haemorrhoidal haemorrhage	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Melaena	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Oesophagitis	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Proctitis	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
General disorders
Death	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Non-cardiac chest pain	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	1/238 (0.4%)	1
Drug-induced liver injury	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Infections and infestations
Hepatitis A	0/252 (0%)	0	0/256 (0%)	0	3/252 (1.2%)	3	3/238 (1.3%)	3
Bronchitis	0/252 (0%)	0	1/256 (0.4%)	1	1/252 (0.4%)	1	0/238 (0%)	0
Gastroenteritis	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Pneumonia	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Acute hepatitis B	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Appendicitis	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Arthritis bacterial	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Cellulitis	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Diverticulitis	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Gastroenteritis viral	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Hepatitis C	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Influenza	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Peritonsillar abscess	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Rectal abscess	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Shigella infection	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Staphylococcal osteomyelitis	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Thyroglossal cyst infection	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Injury, poisoning and procedural complications
Wrist fracture	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Fibula fracture	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Procedural pneumothorax	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Road traffic accident	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease mixed cellularity stage unspecified	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Plasmablastic lymphoma	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Adenocarcinoma of colon	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Anogenital warts	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Breast cancer	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Lung neoplasm malignant	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Neuroendocrine carcinoma	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Non-small cell lung cancer	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Oropharyngeal squamous cell carcinoma	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Pleural neoplasm	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Testicular germ cell tumour mixed	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Thyroid cancer	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Nervous system disorders
Syncope	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	1/238 (0.4%)	1
Carotid artery stenosis	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Loss of consciousness	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Paraesthesia	0/252 (0%)	0	0/256 (0%)	0	0/252 (0%)	0	1/238 (0.4%)	1
Toxic encephalopathy	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Transient ischaemic attack	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Psychiatric disorders
Suicide attempt	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	1/238 (0.4%)	1
Panic attack	1/252 (0.4%)	1	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Reproductive system and breast disorders
Ovarian cyst	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Pulmonary embolism	0/252 (0%)	0	1/256 (0.4%)	1	0/252 (0%)	0	0/238 (0%)	0
Vascular disorders
Peripheral artery stenosis	0/252 (0%)	0	0/256 (0%)	0	1/252 (0.4%)	1	0/238 (0%)	0
Other (Not Including Serious) Adverse Events
	DTG + RPV (Early Switch)		CAR (Early Switch)		DTG + RPV (Early + Late Switch)		CAR (Late Switch)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	107/252 (42.5%)		102/256 (39.8%)		167/252 (66.3%)		134/238 (56.3%)
Gastrointestinal disorders
Diarrhoea	22/252 (8.7%)	24	17/256 (6.6%)	18	35/252 (13.9%)	38	19/238 (8%)	20
General disorders
Fatigue	9/252 (3.6%)	9	3/256 (1.2%)	3	13/252 (5.2%)	14	6/238 (2.5%)	6
Infections and infestations
Nasopharyngitis	27/252 (10.7%)	33	31/256 (12.1%)	35	52/252 (20.6%)	84	39/238 (16.4%)	55
Syphilis	8/252 (3.2%)	10	7/256 (2.7%)	7	27/252 (10.7%)	39	20/238 (8.4%)	24
Upper respiratory tract infection	7/252 (2.8%)	9	10/256 (3.9%)	11	26/252 (10.3%)	32	17/238 (7.1%)	25
Influenza	4/252 (1.6%)	4	12/256 (4.7%)	13	12/252 (4.8%)	12	13/238 (5.5%)	16
Bronchitis	7/252 (2.8%)	7	4/256 (1.6%)	5	16/252 (6.3%)	19	11/238 (4.6%)	14
Urinary tract infection	9/252 (3.6%)	9	2/256 (0.8%)	2	13/252 (5.2%)	13	3/238 (1.3%)	3
Musculoskeletal and connective tissue disorders
Back pain	8/252 (3.2%)	9	19/256 (7.4%)	20	25/252 (9.9%)	28	18/238 (7.6%)	19
Pain in extremity	9/252 (3.6%)	9	5/256 (2%)	6	18/252 (7.1%)	19	12/238 (5%)	16
Arthralgia	8/252 (3.2%)	10	4/256 (1.6%)	5	14/252 (5.6%)	17	17/238 (7.1%)	19
Nervous system disorders
Headache	24/252 (9.5%)	25	17/256 (6.6%)	19	37/252 (14.7%)	43	23/238 (9.7%)	29
Psychiatric disorders
Insomnia	9/252 (3.6%)	10	6/256 (2.3%)	6	18/252 (7.1%)	20	18/238 (7.6%)	20
Depression	10/252 (4%)	10	2/256 (0.8%)	2	17/252 (6.7%)	18	5/238 (2.1%)	6
Respiratory, thoracic and mediastinal disorders
Cough	3/252 (1.2%)	3	9/256 (3.5%)	9	10/252 (4%)	10	13/238 (5.5%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.