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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02429791
Enrollment
510
Registered
2015-04-29
Start date
2015-04-14
Completion date
2023-05-30
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

two-drug regimen, virologically-suppressed, dolutegravir plus rilpivirine, integrase inhibitor, protease inhibitor, NNRTI-sparing, non-nucleoside reverse transcriptase inhibitor, HIV, nucleoside reverse transcriptase inhibitors

Brief summary

The aim of this study was 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 primarily assessed 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 included 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study included 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 participated in the Early Switch Phase where they either switched from their CAR to DTG + RPV, or continued taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants proceeded to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups received DTG + RPV therapy until Week 148. After Week 148, eligible subjects were given the opportunity to continue receiving DTG +RPV, in the Continuation Phase.

Interventions

Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.

Participants received one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV.

DRUGCAR

CAR included the following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI

Sponsors

Janssen Pharmaceuticals
CollaboratorINDUSTRY
GlaxoSmithKline
CollaboratorINDUSTRY
ViiV Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants must have been able to understand and comply with protocol requirements, instructions, and restrictions. * Participants must have been likely to complete the study as planned. * Participants must have been 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 greater than or equal to (\>=)18 years of age. * Must have been 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 have been eligible to enter and participate in the study if she was 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 could 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 included: 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 have been 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 was 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 were not acceptable methods of contraception. * Participants who were willing and able to understand requirements of study participation and provided signed and dated written informed consent prior to screening. * For participants enrolled in France: participants were 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 were pregnant, breastfeeding or planned to become pregnant or breastfeed during the study. * Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions included 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 were excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb were 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 posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should have been considered when evaluating for suicide risk; * Any pre-existing physical or mental condition which, in the opinion of the Investigator, could have interfered with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which could have compromised the safety of the participants; * Any condition which, in the opinion of the Investigator, could have interfered 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 were 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 were participating or anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization * 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 were unwilling or unable to switch to an alternate medication. 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. * Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test was 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 greater than \[\>\] 35% direct bilirubin). * Corrected QT interval (QTc \[Bazett\]) \>450 milliseconds or QTc (Bazett) \>480 milliseconds for participants with bundle branch block. The QTc was the QT interval corrected for heart rate according to Bazett's formula (QTcB).

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot AlgorithmWeek 48Percentage 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.

Secondary

MeasureTime frameDescription
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseWeek 52 to Week 411For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseUp to Week 411Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: 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.
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseUp to Week 411Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: 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.
Number of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseWeek 52 to Week 411Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: 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.
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseWeek 52 to Week 411Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: 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.
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48At Weeks 24 and 48Blood 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.
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot AlgorithmWeek 24Percentage 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.
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 411 or study discontinuationAn 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.
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksUp to 48 weeksBlood 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.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksUp to 48 weeksBlood 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.
Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48At Week 48Blood 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.
Mean Change From Baseline in Cystatin C at Week 48At Week 48Blood 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.
Mean Change From Baseline in D-Dimer at Week 48At Week 48Blood 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.
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48At Week 48Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble cluster designation (CD)14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48At Week 48Blood 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.
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48At Week 48Blood 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.
Mean Change From Baseline in Urine Phosphate at Week 48At Week 48Urine 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.
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48At Week 48Blood 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.
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48At Week 48Urine 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.
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 48At Week 48Blood 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.
Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48At Week 48Blood 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.
Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48At Week 48Blood 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.
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48At Week 24 and at Week 48Blood 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.
Number of Participants With Genotypic Resistance- Early Switch PhaseUp to Week 52Plasma samples were collected for drug resistance testing. 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.
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseUp to Week 148Plasma 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.
Number of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePost-Late switch (LS) Baseline (Week 52) up to Week 148Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Number of Participants With Phenotypic Resistance-Early Switch PhaseUp to Week 52Plasma 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.
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseUp to Week 148Plasma 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.
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePost-LS Baseline (Week 52) up to Week 148Plasma 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.
Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhasePre-dose at Week 4, 24, 48, 56, 76 and 100Two 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.
Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhasePre-dose at Weeks 56, 76 and 100Two 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.
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 + RPVPre-dose at Week 2, 4 and 8Two 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.
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassWeek 48Percentage 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.
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassAt Week 48Blood 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.
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 ClassUp to 48 weeksAn 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.
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassUp to 48 weeksBlood 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.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassUp to 48 weeksBlood 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.
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment ClassUp to Week 48For 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.
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment ClassUp to Week 48For 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.
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassAt Week 24 and at Week 48Blood 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.
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseAt Week 4, Week 24 and Week 48Symptom 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.
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseAt Week 56, Week 76, Week 100 and Week 148Symptom 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.
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseAt Week 56, Week 76, Week 100 and Week 148Symptom 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.
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseAt Week 4, Week 24 and Week 48HIV 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.
Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseAt Week 56, Week 76, Week 100 and Week 148HIV 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.
Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseAt Week 56, Week 76, Week 100 and Week 148HIV 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.
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseUp to Week 411For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseUp to Week 411For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseWeek 52 to Week 411For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.

Other

MeasureTime frameDescription
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch PhaseAt Weeks 100 and 148Plasma 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.
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch PhaseAt Weeks 100 and 148Blood 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.
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseAt Weeks 100 and 148Blood 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.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch PhaseAt Weeks 100 and 148Plasma 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.

Countries

Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Russia, Spain, Taiwan, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted at 65 centers in 13 countries.

Pre-assignment details

510 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included an Early Switch Phase, a Late Switch Phase, and a Continuation Phase.

Participants by arm

ArmCount
DTG + RPV
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 the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
252
Current Antiretroviral Regimen (CAR)
Participants continued to receive their CAR (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 the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (\<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
256
Total508

Withdrawals & dropouts

PeriodReasonFG000FG001
Continuation Phase(Week 148 to Week 411)Adverse Event31
Continuation Phase(Week 148 to Week 411)Investigator discretion02
Continuation Phase(Week 148 to Week 411)Lack of Efficacy10
Continuation Phase(Week 148 to Week 411)Lost to Follow-up11
Continuation Phase(Week 148 to Week 411)Protocol Violation10
Continuation Phase(Week 148 to Week 411)Withdrawal by Subject11
Early Switch Phase (Up to Week 52)Adverse Event62
Early Switch Phase (Up to Week 52)Lack of Efficacy21
Early Switch Phase (Up to Week 52)Lost to Follow-up12
Early Switch Phase (Up to Week 52)Physician Decision02
Early Switch Phase (Up to Week 52)Protocol Violation14
Early Switch Phase (Up to Week 52)Withdrawal by Subject37
Late Switch Phase (Week 52 to Week 148)Adverse Event1112
Late Switch Phase (Week 52 to Week 148)Lack of Efficacy43
Late Switch Phase (Week 52 to Week 148)Lost to Follow-up01
Late Switch Phase (Week 52 to Week 148)Physician Decision04
Late Switch Phase (Week 52 to Week 148)Protocol Violation33
Late Switch Phase (Week 52 to Week 148)Withdrawal by Subject75

Baseline characteristics

CharacteristicDTG + RPVCurrent Antiretroviral Regimen (CAR)Total
Age, Continuous43.6 Years
STANDARD_DEVIATION 10.93
43.6 Years
STANDARD_DEVIATION 10.76
43.6 Years
STANDARD_DEVIATION 10.84
Race/Ethnicity, Customized
African American/African H. and Asian
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
3 Participants6 Participants9 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native and white
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Black/African American
24 Participants27 Participants51 Participants
Race/Ethnicity, Customized
Japanese/East Asian (EA) Heritage (H.)/South EA H.
25 Participants34 Participants59 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White
198 Participants188 Participants386 Participants
Sex: Female, Male
Female
58 Participants51 Participants109 Participants
Sex: Female, Male
Male
194 Participants205 Participants399 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 2521 / 2561 / 2520 / 2380 / 1860 / 183
other
Total, other adverse events
107 / 252102 / 256167 / 252134 / 2380 / 1860 / 183
serious
Total, serious adverse events
10 / 25213 / 25634 / 25222 / 2386 / 1869 / 183

Outcome results

Primary

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

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.

Time frame: Week 48

Population: The analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which consisted of all randomly assigned participants who received at least one dose of study drug.

ArmMeasureValue (NUMBER)
DTG + RPVPercentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm95 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm96 Percentage of participants
95% CI: [-4.3, 3]
Secondary

Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class

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: At Week 24 and at Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, Overall, Week 240.017 mmol/mLStandard Deviation 18.7575
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 483.605 mmol/mLStandard Deviation 54.4914
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, overall3.596 mmol/mLStandard Deviation 18.7072
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, Overall, Week 2411.504 mmol/mLStandard Deviation 36.9087
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, Overall, Week 483.975 mmol/mLStandard Deviation 21.1039
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, Overall, Week 488.257 mmol/mLStandard Deviation 33.0405
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, overall3.239 mmol/mLStandard Deviation 18.1556
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 240.096 mmol/mLStandard Deviation 55.6357
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, PI0.575 mmol/mLStandard Deviation 15.7475
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, Overall, Week 24-2.478 mmol/mLStandard Deviation 16.6754
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, Overall, Week 483.095 mmol/mLStandard Deviation 18.8909
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, NNRTI, Week 240.062 mmol/mLStandard Deviation 15.93
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, NNRTI, Week 484.818 mmol/mLStandard Deviation 16.2253
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, INI, Week 24-4.968 mmol/mLStandard Deviation 16.2973
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, INI, Week 480.539 mmol/mLStandard Deviation 22.6496
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, PI, Week 24-5.594 mmol/mLStandard Deviation 17.7923
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, PI, Week 481.457 mmol/mLStandard Deviation 20.8346
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, Overall, Week 246.196 mmol/mLStandard Deviation 24.0104
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, Overall, Week 483.258 mmol/mLStandard Deviation 22.3644
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, NNRTI, Week 246.816 mmol/mLStandard Deviation 20.9081
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, NNRTI, Week 484.920 mmol/mLStandard Deviation 20.93
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, INI, Week 246.355 mmol/mLStandard Deviation 24.1747
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, INI, Week 483.490 mmol/mLStandard Deviation 23.3198
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, PI, Week 244.813 mmol/mLStandard Deviation 29.5705
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, PI, Week 48-0.434 mmol/mLStandard Deviation 24.4332
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 248.649 mmol/mLStandard Deviation 48.8249
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 4811.068 mmol/mLStandard Deviation 54.6321
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, NNRTI, Week 246.867 mmol/mLStandard Deviation 44.8605
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, NNRTI, Week 4810.215 mmol/mLStandard Deviation 58.4055
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, INI, Week 248.386 mmol/mLStandard Deviation 54.1265
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, INI, Week 484.644 mmol/mLStandard Deviation 48.8708
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, PI, Week 4817.681 mmol/mLStandard Deviation 50.6912
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, PI, Week 2412.283 mmol/mLStandard Deviation 52.6943
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, overall2.375 mmol/mLStandard Deviation 14.8357
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, overall2.472 mmol/mLStandard Deviation 14.7202
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, NNRTI3.383 mmol/mLStandard Deviation 13.3685
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, NNRTI4.099 mmol/mLStandard Deviation 13.8992
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, INI1.288 mmol/mLStandard Deviation 14.8933
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, INI0.524 mmol/mLStandard Deviation 15.3143
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, PI1.211 mmol/mLStandard Deviation 17.3972
Secondary

Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase

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: At Week 4, Week 24 and Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom count, Week 4-1.6 Scores on a scaleStandard Deviation 4.19
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom count, Week 24-0.8 Scores on a scaleStandard Deviation 5.19
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom count, Week 48-0.4 Scores on a scaleStandard Deviation 5.52
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom Bother Score, Week 4-3.0 Scores on a scaleStandard Deviation 7.25
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom Bother Score, Week 24-1.7 Scores on a scaleStandard Deviation 8.47
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom Bother Score, Week 48-1.4 Scores on a scaleStandard Deviation 8.32
Current Antiretroviral Regimen (CAR)Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom Bother Score, Week 24-1.3 Scores on a scaleStandard Deviation 8.53
Current Antiretroviral Regimen (CAR)Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom count, Week 40.2 Scores on a scaleStandard Deviation 4.26
Current Antiretroviral Regimen (CAR)Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom Bother Score, Week 4-0.8 Scores on a scaleStandard Deviation 7.82
Current Antiretroviral Regimen (CAR)Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom count, Week 24-0.2 Scores on a scaleStandard Deviation 4.06
Current Antiretroviral Regimen (CAR)Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom Bother Score, Week 48-0.7 Scores on a scaleStandard Deviation 9.03
Current Antiretroviral Regimen (CAR)Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch PhaseSymptom count, Week 480.0 Scores on a scaleStandard Deviation 4.49
p-value: 0.94ANCOVA
p-value: <0.00195% CI: [-4.26, -1.588]ANCOVA
p-value: 0.001ANCOVA
p-value: 0.1195% CI: [-2.656, 0.271]ANCOVA
p-value: 0.048ANCOVA
p-value: 0.03895% CI: [-3.048, -0.09]ANCOVA
Secondary

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

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: At Week 56, Week 76, Week 100 and Week 148

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom count, Week 56-0.9 Scores on a scaleStandard Deviation 4.99
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom count, Week 76-0.2 Scores on a scaleStandard Deviation 5.42
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom count, Week 100-0.4 Scores on a scaleStandard Deviation 5.08
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom count, Week 148-0.6 Scores on a scaleStandard Deviation 5.24
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom Bother Score, Week 56-1.6 Scores on a scaleStandard Deviation 8.52
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom Bother Score, Week 76-0.9 Scores on a scaleStandard Deviation 8.84
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom Bother Score, Week 100-0.8 Scores on a scaleStandard Deviation 8.71
DTG + RPVChange From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseSymptom Bother Score, Week 148-0.8 Scores on a scaleStandard Deviation 9.15
Secondary

Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase

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: At Week 56, Week 76, Week 100 and Week 148

Population: ITT-E Population

ArmMeasureGroupValue (MEDIAN)
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 560.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 760.5 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 1000.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 1481.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseLifestyle/ease Sub-score, Week 560.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseLifestyle/ease Sub-score, Week 760.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseLifestyle/ease Sub-score, Week 1000.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseLifestyle/ease Sub-score, Week 1480.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 560.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 760.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 1000.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 1480.0 Scores on a scale
Secondary

Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase

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: At Week 4, Week 24 and Week 48

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

ArmMeasureGroupValue (MEDIAN)
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseTotal score, Week 241.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phaselifestyle/ease Sub-score, Week 480.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phaselifestyle/ease Sub-score, Week 40.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseGeneral Satisfaction/CS, Week 40.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseTotal score, Week 480.5 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseGeneral Satisfaction/CS, Week 240.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phaselifestyle/ease Sub-score, Week 240.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseGeneral Satisfaction/CS, Week 480.0 Scores on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseTotal score, Week 40.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseGeneral Satisfaction/CS, Week 480.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseTotal score, Week 40.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseTotal score, Week 240.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseTotal score, Week 480.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phaselifestyle/ease Sub-score, Week 40.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phaselifestyle/ease Sub-score, Week 240.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phaselifestyle/ease Sub-score, Week 480.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseGeneral Satisfaction/CS, Week 40.0 Scores on a scale
Current Antiretroviral Regimen (CAR)Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseGeneral Satisfaction/CS, Week 240.0 Scores on a scale
p-value: 0.002Wilcoxon rank sum test
p-value: <0.001Wilcoxon rank sum test
p-value: 0.024Wilcoxon rank sum test
p-value: <0.001Wilcoxon rank sum test
p-value: <0.001Wilcoxon rank sum test
p-value: 0.005Wilcoxon rank sum test
p-value: 0.063Wilcoxon rank sum test
p-value: 0.002Wilcoxon rank sum test
p-value: 0.099Wilcoxon rank sum test
Secondary

Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase

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: At Week 56, Week 76, Week 100 and Week 148

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom count, Week 56-0.7 Scores on a scaleStandard Deviation 4.38
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom count, Week 760.1 Scores on a scaleStandard Deviation 4.19
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom count, Week 1000.0 Scores on a scaleStandard Deviation 4.35
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom count, Week 1480.4 Scores on a scaleStandard Deviation 4.92
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom Bother Score, Week 56-2.0 Scores on a scaleStandard Deviation 8.11
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom Bother Score, Week 76-0.4 Scores on a scaleStandard Deviation 8.33
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom Bother Score, Week 100-0.4 Scores on a scaleStandard Deviation 9.17
DTG + RPVChange From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseSymptom Bother Score, Week 1480.7 Scores on a scaleStandard Deviation 9.57
Secondary

Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase

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: At Week 56, Week 76, Week 100 and Week 148

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

ArmMeasureGroupValue (MEDIAN)
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 560.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 760.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 1000.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 1480.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseLifestyle/ease Sub-score, Week 560.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseLifestyle/ease Sub-score, Week 760.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseLifestyle/ease Sub-score, Week 1000.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseLifestyle/ease Sub-score, Week 1480.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 560.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 760.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 1000.0 Scores on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 1480.0 Scores on a scale
Secondary

Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class

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: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChanges From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassNNRTI47.9 Cells per mm^3Standard Deviation 142.9
DTG + RPVChanges From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassINI19.9 Cells per mm^3Standard Deviation 148.63
DTG + RPVChanges From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassPI12.5 Cells per mm^3Standard Deviation 160.27
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassNNRTI25.0 Cells per mm^3Standard Deviation 151.27
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassINI39.9 Cells per mm^3Standard Deviation 200.38
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassPI74.7 Cells per mm^3Standard Deviation 227.78
Secondary

Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at 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.

Time frame: At Weeks 24 and 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChanges From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 2416.2 Cells per millimeter cube (mm^3)Standard Deviation 150.34
DTG + RPVChanges From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 4832.3 Cells per millimeter cube (mm^3)Standard Deviation 149.52
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 2447.4 Cells per millimeter cube (mm^3)Standard Deviation 179.68
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 4841.8 Cells per millimeter cube (mm^3)Standard Deviation 185.53
Secondary

Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at 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.

Time frame: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Blood B2M-15.1452 Nanomoles/ LStandard Deviation 44.55903
DTG + RPVMean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Blood 25 hydroxy-vitamin D-13.9 Nanomoles/ LStandard Deviation 22.76
DTG + RPVMean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Urine B2M-128.2045 Nanomoles/ LStandard Deviation 726.38825
DTG + RPVMean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Urine RBP-8.8395 Nanomoles/ LStandard Deviation 28.83977
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Urine RBP-0.5851 Nanomoles/ LStandard Deviation 27.56405
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Blood B2M-4.5995 Nanomoles/ LStandard Deviation 38.90474
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Urine B2M39.8394 Nanomoles/ LStandard Deviation 253.43025
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48Blood 25 hydroxy-vitamin D-8.2 Nanomoles/ LStandard Deviation 24.43
p-value: 0.007ANCOVA
p-value: 0.27595% CI: [0.888, 1.034]ANCOVA
p-value: 0.11295% CI: [0.793, 1.025]ANCOVA
p-value: 0.00295% CI: [0.763, 0.942]ANCOVA
Secondary

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

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: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean 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 48Procollagen type 1 N-propeptide-9.1 µg/ LStandard Deviation 20.34
DTG + RPVMean 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 48Type I Collagen C-Telopeptides-0.18 µg/ LStandard Deviation 0.307
DTG + RPVMean 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 48Osteocalcin-4.40 µg/ LStandard Deviation 7.605
DTG + RPVMean 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 48sVCAM-2.21 µg/ LStandard Deviation 1291.994
DTG + RPVMean 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 48Bone-specific alkaline phosphatase-2.89 µg/ LStandard Deviation 4.024
Current Antiretroviral Regimen (CAR)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 48sVCAM89.07 µg/ LStandard Deviation 1239.465
Current Antiretroviral Regimen (CAR)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 48Bone-specific alkaline phosphatase0.90 µg/ LStandard Deviation 4.129
Current Antiretroviral Regimen (CAR)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 48Procollagen type 1 N-propeptide-1.4 µg/ LStandard Deviation 18.95
Current Antiretroviral Regimen (CAR)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 48Osteocalcin-0.68 µg/ LStandard Deviation 6.579
Current Antiretroviral Regimen (CAR)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 48Type I Collagen C-Telopeptides-0.04 µg/ LStandard Deviation 1.16
p-value: 0.001ANCOVA
p-value: <0.00195% CI: [0.679, 0.772]ANCOVA
p-value: <0.00195% CI: [0.742, 0.918]ANCOVA
p-value: <0.00195% CI: [0.742, 0.884]ANCOVA
p-value: 0.677ANCOVA
p-value: <0.00195% CI: [0.774, 0.863]ANCOVA
p-value: <0.001ANCOVA
p-value: <0.00195% CI: [0.823, 0.943]ANCOVA
p-value: 0.00195% CI: [0.74, 0.93]ANCOVA
p-value: <0.00195% CI: [0.628, 0.759]ANCOVA
p-value: 0.782ANCOVA
p-value: <0.00195% CI: [0.742, 0.872]ANCOVA
Secondary

Mean Change From Baseline in Cystatin C at 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.

Time frame: At Week 48

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

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Cystatin C at Week 480.00 mg/LStandard Deviation 0.113
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Cystatin C at Week 48-0.01 mg/LStandard Deviation 0.106
Secondary

Mean Change From Baseline in D-Dimer at 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.

Time frame: At Week 48

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

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in D-Dimer at Week 48-0.02 Nanomole/L fibrinogen equivalent unitsStandard Deviation 2.651
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in D-Dimer at Week 480.02 Nanomole/L fibrinogen equivalent unitsStandard Deviation 2.501
Secondary

Mean Change From Baseline in Fasting Lipids at Weeks 24 and 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.

Time frame: At Week 24 and at Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 240.076 mmol/ LStandard Deviation 0.8398
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 480.089 mmol/ LStandard Deviation 0.8488
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 240.165 mmol/ LStandard Deviation 0.7065
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 480.108 mmol/ LStandard Deviation 0.7178
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 24-0.030 mmol/ LStandard Deviation 0.2601
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 480.023 mmol/ LStandard Deviation 0.2757
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 24-0.154 mmol/ LStandard Deviation 0.7324
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 48-0.093 mmol/ LStandard Deviation 0.9767
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 480.046 mmol/ LStandard Deviation 0.8274
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 240.061 mmol/ LStandard Deviation 0.7368
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 24-0.044 mmol/ LStandard Deviation 0.2394
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 480.064 mmol/ LStandard Deviation 0.7197
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 240.103 mmol/ LStandard Deviation 0.6503
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 24-0.001 mmol/ LStandard Deviation 0.7712
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 480.018 mmol/ LStandard Deviation 0.2722
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 480.029 mmol/ LStandard Deviation 0.6134
Secondary

Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble cluster designation (CD)14. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Time frame: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48FABP-2.79 Nanogram/milliliterStandard Deviation 3.007
DTG + RPVMean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48Soluble CD14379.72 Nanogram/milliliterStandard Deviation 634.053
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48FABP-1.93 Nanogram/milliliterStandard Deviation 2.15
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48Soluble CD14754.54 Nanogram/milliliterStandard Deviation 656.462
Secondary

Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at 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.

Time frame: At Week 48

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

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 480.11 mg/ Liter (L)Standard Deviation 5.379
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 480.15 mg/ Liter (L)Standard Deviation 4.944
Secondary

Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at 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.

Time frame: At Week 48

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

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48-0.30 HOMA-IR ScoreStandard Deviation 5.74
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 480.51 HOMA-IR ScoreStandard Deviation 3.53
Secondary

Mean Change From Baseline in Interleukin 6 (IL-6) at 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.

Time frame: At Week 48

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

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Interleukin 6 (IL-6) at Week 480.17 Nanograms (ng)/ LStandard Deviation 2.736
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48-0.18 Nanograms (ng)/ LStandard Deviation 2.944
Secondary

Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at 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.

Time frame: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48RBP-0.13 mg/deciliter (dL)Standard Deviation 1.023
DTG + RPVMean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Serum creatinine0.087 mg/deciliter (dL)Standard Deviation 0.1074
DTG + RPVMean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Glucose0.762 mg/deciliter (dL)Standard Deviation 13.6194
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48RBP0.03 mg/deciliter (dL)Standard Deviation 0.974
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Serum creatinine0.011 mg/deciliter (dL)Standard Deviation 0.0876
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Glucose2.492 mg/deciliter (dL)Standard Deviation 12.1674
Secondary

Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at 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.

Time frame: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Soluble CD16350.18 Microgram (µg)/LiterStandard Deviation 188.772
DTG + RPVMean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Oxidized LDL9.49 Microgram (µg)/LiterStandard Deviation 745.962
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Soluble CD16354.26 Microgram (µg)/LiterStandard Deviation 238.9
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Oxidized LDL-41.30 Microgram (µg)/LiterStandard Deviation 726.014
Secondary

Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at 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.

Time frame: At Week 48

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine albumin/creatinine ratio-1.19 Grams (g)/ molStandard Deviation 3.916
DTG + RPVMean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine protein/creatinine ratio-5.63 Grams (g)/ molStandard Deviation 17.219
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine albumin/creatinine ratio-2.59 Grams (g)/ molStandard Deviation 28.878
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine protein/creatinine ratio-1.43 Grams (g)/ molStandard Deviation 42.832
Secondary

Mean Change From Baseline in Urine Phosphate at 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.

Time frame: At Week 48

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

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Urine Phosphate at Week 48-1.079 Millimoles (mmol)/ LStandard Deviation 16.9226
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Urine Phosphate at Week 48-1.511 Millimoles (mmol)/ LStandard Deviation 15.8515
Secondary

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

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Maximum toxicity Grade 3 AE2 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Maximum toxicity Grade 1 AE69 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Maximum toxicity Grade 4 AE1 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Maximum toxicity Grade 3 AE5 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Maximum toxicity Grade 1 AE31 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassAny AE, INI38 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Maximum toxicity Grade 2 AE23 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Maximum toxicity Grade 4 AE1 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Maximum toxicity Grade 3 AE4 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassAny AE, NNRTI102 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Maximum toxicity Grade 4 AE2 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Maximum toxicity Grade 1 AE28 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassAELD, NNRTI3 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassAny AE, PI60 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassAELD, INI2 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Maximum toxicity Grade 2 AE7 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassAELD, PI4 Participants
DTG + RPVNumber of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Maximum toxicity Grade 2 AE27 Participants
Current Antiretroviral Regimen (CAR)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 ClassAELD, PI2 Participants
Current Antiretroviral Regimen (CAR)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 ClassNNRTI, Maximum toxicity Grade 1 AE72 Participants
Current Antiretroviral Regimen (CAR)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 ClassAny AE, NNRTI98 Participants
Current Antiretroviral Regimen (CAR)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 ClassAny AE, INI34 Participants
Current Antiretroviral Regimen (CAR)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 ClassNNRTI, Maximum toxicity Grade 2 AE23 Participants
Current Antiretroviral Regimen (CAR)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 ClassNNRTI, Maximum toxicity Grade 3 AE2 Participants
Current Antiretroviral Regimen (CAR)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 ClassNNRTI, Maximum toxicity Grade 4 AE1 Participants
Current Antiretroviral Regimen (CAR)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 ClassINI, Maximum toxicity Grade 1 AE20 Participants
Current Antiretroviral Regimen (CAR)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 ClassINI, Maximum toxicity Grade 2 AE12 Participants
Current Antiretroviral Regimen (CAR)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 ClassINI, Maximum toxicity Grade 3 AE2 Participants
Current Antiretroviral Regimen (CAR)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 ClassINI, Maximum toxicity Grade 4 AE0 Participants
Current Antiretroviral Regimen (CAR)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 ClassPI, Maximum toxicity Grade 1 AE30 Participants
Current Antiretroviral Regimen (CAR)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 ClassPI, Maximum toxicity Grade 2 AE18 Participants
Current Antiretroviral Regimen (CAR)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 ClassPI, Maximum toxicity Grade 3 AE9 Participants
Current Antiretroviral Regimen (CAR)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 ClassPI, Maximum toxicity Grade 4 AE1 Participants
Current Antiretroviral Regimen (CAR)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 ClassAELD, NNRTI0 Participants
Current Antiretroviral Regimen (CAR)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 ClassAELD, INI0 Participants
Current Antiretroviral Regimen (CAR)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 ClassAny AE, PI58 Participants
Secondary

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)

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.

Time frame: Up to Week 411 or study discontinuation

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber 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)Maximum toxicity Grade 1 AE82 Participants
DTG + RPVNumber 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)Maximum toxicity Grade 3 AE37 Participants
DTG + RPVNumber 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)Any SAE37 Participants
DTG + RPVNumber 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)Maximum toxicity Grade 4 AE15 Participants
DTG + RPVNumber 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)Maximum toxicity Grade 2 AE97 Participants
DTG + RPVNumber 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)AELD22 Participants
DTG + RPVNumber 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)Common non-serious AE158 Participants
Current Antiretroviral Regimen (CAR)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)AELD13 Participants
Current Antiretroviral Regimen (CAR)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)Common non-serious AE126 Participants
Current Antiretroviral Regimen (CAR)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)Any SAE30 Participants
Current Antiretroviral Regimen (CAR)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)Maximum toxicity Grade 1 AE73 Participants
Current Antiretroviral Regimen (CAR)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)Maximum toxicity Grade 2 AE107 Participants
Current Antiretroviral Regimen (CAR)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)Maximum toxicity Grade 3 AE17 Participants
Current Antiretroviral Regimen (CAR)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)Maximum toxicity Grade 4 AE9 Participants
Secondary

Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase

Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: 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.

Time frame: Week 52 to Week 411

Population: The analysis was performed on the Late Switch CVW resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, RPV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, 3TC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, 3TC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ABC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ABC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, FTC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, FTC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, TDF, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, TDF, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ZDV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ZDV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ZDV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, d4T, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, d4T, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, d4T, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ddI, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNRTI, ddI, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, ATV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, DRV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, FPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, IDV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, LPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, LPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, NFV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, NFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, RTV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, SQV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, TPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhasePI, TPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, DTG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, EVG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, EVG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, EVG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, RAL, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, RAL, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseINI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, DLV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, EFV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, EFV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, EFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, EFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, EFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, ETR, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, ETR, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, ETR, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, ETR, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, NVP, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, NVP, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, NVP, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, NVP, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, RPV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, RPV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, RPV, Intermediate resistance0 Participants
Secondary

Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase

Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.

Time frame: Post-Late switch (LS) Baseline (Week 52) up to Week 148

Population: The analysis was performed on the Late Switch (LS) CVW resistance Population which was 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. Only those participants with data available at the specified time point were analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, DTG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, EVG,Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, EVG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, EVG,Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, RAL,Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, RAL, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseINI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI,DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI,NVP, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI,NVP, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI,NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI,NVP, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, NVP, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r,High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, High-level resistance0 Participants
Secondary

Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase

Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: 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.

Time frame: Up to Week 411

Population: The analysis was performed on the CVW Resistance population which included all participants from the Intent-to-Treat Exposed (ITT-E) population who met CVW through the end of the visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, High-level resistance2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, High-level resistance2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Susceptible4 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Susceptible4 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Low-level resistance00 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Susceptible6 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, High-level resistance0 Participants
Secondary

Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase

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

Population: CVW resistance Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG,Susceptible4 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG,Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL,Susceptible4 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI,DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI,NVP, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI,NVP, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI,NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI,NVP, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, NVP, High-level resistance2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Susceptible3 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Susceptible4 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Susceptible4 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r,High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Susceptible5 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Susceptible5 Participants
Secondary

Number of Participants With Genotypic Resistance- Early Switch Phase

Plasma samples were collected for drug resistance testing. 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 52

Population: The analysis was performed on the Confirmed Virologic Withdrawal (CVW) resistance population which was 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Intermediate resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, High-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, SusceptibleNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Potential low-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Low-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Intermediate resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, High-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Low-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, SusceptibleNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, SusceptibleNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Potential low-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Low-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Potential low-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Intermediate resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, High-level resistanceNA Participants
DTG + RPVNumber of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Susceptible1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, High-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, SusceptibleNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Potential low-level resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Low-level resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, Intermediate resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNNRTI, RPV, High-level resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, SusceptibleNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Potential low-level resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Low-level resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, Intermediate resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseINI, DTG, High-level resistanceNA Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Susceptible1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Potential low-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Low-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, Intermediate resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, FTC, High-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Susceptible1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Potential low-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Low-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, Intermediate resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhaseNRTI, TDF, High-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Susceptible1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Potential low-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Low-level resistance0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Genotypic Resistance- Early Switch PhasePI, DRV/r, Intermediate resistance0 Participants
Secondary

Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 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.

Time frame: Up to 48 weeks

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 195 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 261 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 322 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 45 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 49 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 178 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 323 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 286 Participants
Secondary

Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 147 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 232 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 313 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 42 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 113 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 219 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 31 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 43 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 135 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 210 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 38 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 40 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 39 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 142 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 31 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 248 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 223 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 313 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 42 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 43 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 44 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 111 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 125 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI, Grade 215 Participants
Secondary

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 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.

Time frame: Up to 48 weeks

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 111 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 33 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 23 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 40 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 22 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 111 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 41 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 WeeksGrade 31 Participants
Secondary

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 15 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 21 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 31 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 40 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 12 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 21 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 30 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 40 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 14 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 21 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 32 Participants
DTG + RPVNumber of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 40 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 30 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 13 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 30 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 21 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 21 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 31 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 40 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI; Grade 41 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 40 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 12 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI; Grade 16 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 20 Participants
Secondary

Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class

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

Population: CVW resistance Population

Secondary

Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase

For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.

Time frame: Week 52 to Week 411

Population: The analysis was to be performed on the Late Switch CVW Resistance population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, DTG, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, EVG, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, EVG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, EVG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, RAL, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, RAL, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, INI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Susceptible0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Susceptible0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Susceptible0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Susceptible0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, High-level resistance0 Participants
Secondary

Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase

For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.

Time frame: Up to Week 411

Population: The analysis was performed on the CVW Resistance population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, DTG, Susceptible3 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, EVG, Susceptible3 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, EVG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, EVG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, RAL, Susceptible3 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, RAL, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, INI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, DLV, Susceptible3 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, EFV, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, EFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, EFV, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, EFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, EFV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, ETR, Susceptible2 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, ETR, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, ETR, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, ETR, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, NVP, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, NVP, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, NVP, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, NVP, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, RPV, Susceptible2 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, RPV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NNRTI, RPV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, 3TC, Susceptible2 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, 3TC, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ABC, Susceptible2 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ABC, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, FTC, Susceptible2 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, FTC, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, TDF, Susceptible2 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, TDF, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ZDV, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ZDV, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ZDV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, d4T, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, d4T, Potential low-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, d4T, High-level resistance1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseNNRTI, NRTI, ddI, Susceptible2 Participants
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DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, SQV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, TPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, PI, TPV/r, High-level resistance0 Participants
Secondary

Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class

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

Population: CVW resistance Population

Secondary

Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase

For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.

Time frame: Week 52 to Week 411

Population: The analysis was performed on the Late Switch CVW resistance population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Resistant1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, DLV, Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Resistant1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, EFV, Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, ETR, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Resistant1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, NVP, Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NNRTI, RPV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, 3TC, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ABC, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, FTC, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, TDF, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ZDV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, d4T, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, NRTI, ddI, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, ATV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, DRV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, FPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, IDV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, LPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, NFV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, RTV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, SQV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation PhaseINI, PI, TPV/r, Sensitive1 Participants
Secondary

Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase

For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.

Time frame: Up to Week 411

Population: The analysis was performed on the CVW Resistance population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ZDV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ZDV, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, d4T, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, d4T, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ddI, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, ATV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, DRV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, FPV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, IDV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, IDV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, LPV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, NFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, NFV, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, RTV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, RTV, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, SQV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, PI, TPV/r, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, DTG, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, DTG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, DTG, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, EVG, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, EVG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, EVG, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, RAL, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, RAL, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, INI, RAL, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, DLV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, DLV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, DLV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, EFV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, EFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, EFV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, ETR, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, ETR, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, NVP, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, NVP, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, RPV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NNRTI, RPV, Sensitive1 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhasePI, NRTI, 3TC, Resistant0 Participants
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DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NNRTI, NVP, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NNRTI, RPV, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NNRTI, RPV, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, 3TC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, 3TC, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ABC, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, FTC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, FTC, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, TDF, Sensitive2 Participants
DTG + RPVNumber of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation PhaseINI, NRTI, ZDV, Resistant0 Participants
Secondary

Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase

Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: 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.

Time frame: Week 52 to Week 411

Population: The analysis was performed on the Late Switch CVW Resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, DLV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, DLV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, DLV, Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, EFV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, EFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, EFV, Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, ETR, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, ETR, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, NVP, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, NVP, Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, RPV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, RPV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, 3TC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, 3TC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ABC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, FTC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, FTC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, TDF, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ZDV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ZDV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ZDV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, d4T, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, d4T, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNRTI, ddI, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, ATV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, DRV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, FPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, IDV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, IDV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, LPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, NFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, NFV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, RTV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, RTV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, SQV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhasePI, TPV/r, Sensitive1 Participants
Secondary

Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, DLV, Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, EFV, Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, NVP, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, NVP, Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, RPV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, 3TC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ABC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, FTC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, TDF, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ZDV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, d4T, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNRTI, ddI, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, ATV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, DRV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, FPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, IDV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, LPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, NFV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, RTV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, SQV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhasePI, TPV/r, Sensitive1 Participants
Secondary

Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase

Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: 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.

Time frame: Up to Week 411

Population: The analysis was performed on the CVW Resistance population which included all participants from the ITT-E population who met CVW through the end of the visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, DLV, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, EFV, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Partially Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ABC, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, TDF, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, LPV/r, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, NFV, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, RTV, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, SQV/r, Sensitive6 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Sensitive6 Participants
Secondary

Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase

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

Population: CVW resistance Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, DTG, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, EVG, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, DLV, Sensitive4 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, EFV, Sensitive4 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Partially Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Sensitive4 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, NVP, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, NVP, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, NVP, Sensitive4 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, RPV, Sensitive4 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, 3TC, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ABC, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, FTC, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, TDF, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ZDV, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, d4T, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNRTI, ddI, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, ATV/r, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, DRV/r, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, FPV/r, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, IDV/r, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, LPV/r, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, NFV, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, RTV, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, SQV/r, Sensitive5 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhasePI, TPV/r, Sensitive5 Participants
Secondary

Number of Participants With Phenotypic Resistance-Early Switch Phase

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 52

Population: CVW resistance Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, NVP, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, DTG, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, DTG, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, EVG, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, EVG, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, RAL, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, RAL, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, DLV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, DLV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, EFV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, EFV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, ETR, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, ETR, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, ETR, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseINI, DTG, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, NVP, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, RPV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, RPV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, 3TC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, 3TC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ABC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ABC, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ABC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI,FTC, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, FTC, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, TDF, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, TDF, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, TDF, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ZDV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ZDV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, d4T, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, d4T, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ddI, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ddI, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ddI, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, ATV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, DRV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, ATV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, DRV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, FPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, FPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, FPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, IDV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, IDV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, LPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, LPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, LPV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, NFV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, NFV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, RTV, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, RTV, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, SQV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, SQV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, SQV/r, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, TPV/r, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, TPV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhasePI, TPV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, IDV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, DTG, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ZDV, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, DTG, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, SQV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, DTG, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, d4T, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, EVG, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, IDV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, EVG, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, d4T, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, RAL, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, RTV, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseINI, RAL, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ddI, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, DLV, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, LPV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, DLV, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ddI, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, EFV, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, TPV/r, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, EFV, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ddI, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, ETR, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, LPV/r, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, ETR, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, SQV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, ETR, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, ATV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, NVP, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, LPV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, NVP, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, ATV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, RPV, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, TPV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, RPV, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, DRV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, 3TC, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, NFV, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, 3TC, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, DRV/r, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ABC, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, DRV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ABC, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, SQV/r, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ABC, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, FPV/r, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI,FTC, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, NFV, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, FTC, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, FPV/r, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, TDF, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, TPV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, TDF, Partially Sensitive0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, FPV/r, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, TDF, Sensitive1 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhasePI, RTV, Resistant0 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Phenotypic Resistance-Early Switch PhaseNRTI, ZDV, Resistant0 Participants
Secondary

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

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

Population: ITT-E Population

ArmMeasureValue (NUMBER)
DTG + RPVPercentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm98 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm96 Percentage of participants
95% CI: [-1.9, 4]
Secondary

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

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

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

ArmMeasureGroupValue (NUMBER)
DTG + RPVPercentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassNNRTI95 Percentage of participants
DTG + RPVPercentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassINI98 Percentage of participants
DTG + RPVPercentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassPI95 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassINI96 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassNNRTI98 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassPI92 Percentage of participants
p-value: 0.317Chi-squared, Corrected
95% CI: [-7.7, 1.5]
95% CI: [-5.1, 9]
95% CI: [-5.3, 10.8]
Secondary

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

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.

Time frame: Pre-dose at Week 2, 4 and 8

Population: The analysis was performed on the PK Parameter NNRTI Subset Extra Sampling Population which 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. Only those participants with data available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVPre-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 + RPVWeek 2821.25 µg/LStandard Deviation 574.607
DTG + RPVPre-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 + RPVWeek 4994.00 µg/LStandard Deviation 581.201
DTG + RPVPre-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 + RPVWeek 81561.34 µg/LStandard Deviation 1096.381
Current Antiretroviral Regimen (CAR)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 + RPVWeek 265.360 µg/LStandard Deviation 31.2965
Current Antiretroviral Regimen (CAR)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 + RPVWeek 467.374 µg/LStandard Deviation 27.5663
Current Antiretroviral Regimen (CAR)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 + RPVWeek 877.416 µg/LStandard Deviation 37.7129
Secondary

Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase

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.

Time frame: Pre-dose at Week 4, 24, 48, 56, 76 and 100

Population: The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 41581.06 µg/LStandard Deviation 1146.86
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 241835.68 µg/LStandard Deviation 1120.539
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 481915.11 µg/LStandard Deviation 1304.238
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 561872.65 µg/LStandard Deviation 1173.815
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 761711.83 µg/LStandard Deviation 1092.143
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 1001854.17 µg/LStandard Deviation 1197.958
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 7688.10 µg/LStandard Deviation 42.25
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 492.05 µg/LStandard Deviation 138.288
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 5695.38 µg/LStandard Deviation 53.602
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 2487.88 µg/LStandard Deviation 39.141
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 10092.38 µg/LStandard Deviation 44.604
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch PhaseWeek 4895.18 µg/LStandard Deviation 48.228
Secondary

Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch Phase

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.

Time frame: Pre-dose at Weeks 56, 76 and 100

Population: The analysis was performed on the LS PK Parameter Population which was 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. Only those participants with data available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhaseWeek 561738.55 µg/LStandard Deviation 1329.931
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhaseWeek 761800.39 µg/LStandard Deviation 1162.37
DTG + RPVPre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhaseWeek 1001907.20 µg/LStandard Deviation 1235.676
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhaseWeek 5684.14 µg/LStandard Deviation 47.29
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhaseWeek 7697.79 µg/LStandard Deviation 52.532
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch PhaseWeek 100101.93 µg/LStandard Deviation 63.296
Other Pre-specified

Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase

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: At Weeks 100 and 148

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChange From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseWeek 14839.9 Cells/mm^3Standard Deviation 174.4
DTG + RPVChange From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseWeek 10025.1 Cells/mm^3Standard Deviation 156.31
Other Pre-specified

Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase

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: At Weeks 100 and 148

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

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVChange From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch PhaseWeek 100-3.3 Cells/mm^3Standard Deviation 180.82
DTG + RPVChange From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch PhaseWeek 1483.7 Cells/mm^3Standard Deviation 205.29
Other Pre-specified

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

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: At Weeks 100 and 148

Population: LS ITT-E Population

ArmMeasureGroupValue (NUMBER)
DTG + RPVPercentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch PhaseWeek 10090 Percentage of participants
DTG + RPVPercentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch PhaseWeek 14887 Percentage of participants
Other Pre-specified

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

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: At Weeks 100 and 148

Population: ITT-E Population

ArmMeasureGroupValue (NUMBER)
DTG + RPVPercentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch PhaseWeek 10088 Percentage of participants
DTG + RPVPercentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch PhaseWeek 14885 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026