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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-2)

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
NCT02422797
Enrollment
518
Registered
2015-04-21
Start date
2015-04-21
Completion date
2023-05-25
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

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

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 the 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, subjects could have been eligible to continue to receive 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 DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants 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), 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 410For 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 (NNRTI) were summarized.
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseUp to Week 410Plasma 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 410Plasma 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 410Plasma 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 Phenotypic Resistance- CAR Group Through Continuation PhaseWeek 52 to Week 410Plasma 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: 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. Change from Baseline was calculated as value at indicated time point minus Baseline value.
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.
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 410 or study discontinuationAn AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with \>5% incidence for either treatment.
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 the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.
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 the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.
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 CD14 at Week 48At Week 48Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
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 to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.
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 biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
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 1 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 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
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, 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 Weeks 24 and 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 48Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine \[RPV\], Dolutegravir \[DTG\]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented.
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 Genotypic Resistance-DTG+RPV Arm 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 Confirmed Virologic Withdrawal Criteria has been presented.
Number of Participants With Genotypic Resistance-CAR Arm 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-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 (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.
Pre-dose Concentrations of DTG and RPV 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 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 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVPre-dose at Weeks 2, 4 and 8Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment ClassAt Week 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 (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.
Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassAt Week 48Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
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 (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
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 at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
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 at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment ClassWeek 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.
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment ClassWeek 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.
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassAt Weeks 24 and 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 Weeks 4, 24 and 48The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
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 Weeks 56, 76, 100 and 148The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
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 Weeks 56, 76, 100 and 148The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch PhaseAt Weeks 4, 24 and 48The 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 to 6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseAt Weeks 56, 76, 100 and 148The 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. Change from Baseline is calculated as the value at specified time point minus Baseline value. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis.
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseAt Weeks 56, 76, 100 and 148The 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. Change from LS Baseline is calculated as the value at specified time point minus LS Baseline value. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis.
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 410For 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) 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 410For 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) 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 410For 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 (NNRTI) 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 PhaseWeeks 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 PhaseLS Baseline (Week 48), 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 PhaseWeeks 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, Canada, France, Germany, Italy, Russia, Spain, Taiwan, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted at 60 centers in 11 countries.

Pre-assignment details

518 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 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants 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).
261
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
255
Total516

Withdrawals & dropouts

PeriodReasonFG000FG001
Continuation Phase(Week 148 to Week 410)Adverse Event02
Continuation Phase(Week 148 to Week 410)Investigator discretion12
Continuation Phase(Week 148 to Week 410)Lack of Efficacy11
Continuation Phase(Week 148 to Week 410)Lost to Follow-up03
Continuation Phase(Week 148 to Week 410)Protocol Violation01
Continuation Phase(Week 148 to Week 410)Subject reached protocol-defined stopping criteria10
Continuation Phase(Week 148 to Week 410)Withdrawal by Subject41
Early Switch Phase (Up to Week 52)Adverse Event111
Early Switch Phase (Up to Week 52)Lack of Efficacy12
Early Switch Phase (Up to Week 52)Lost to Follow-up11
Early Switch Phase (Up to Week 52)Physician Decision01
Early Switch Phase (Up to Week 52)Protocol Violation03
Early Switch Phase (Up to Week 52)Reached stopping criteria11
Early Switch Phase (Up to Week 52)Withdrawal by Subject27
Late Switch Phase (Week 52 to Week 148)Adverse Event106
Late Switch Phase (Week 52 to Week 148)Lack of Efficacy53
Late Switch Phase (Week 52 to Week 148)Lost to Follow-up22
Late Switch Phase (Week 52 to Week 148)Physician Decision01
Late Switch Phase (Week 52 to Week 148)Protocol Violation30
Late Switch Phase (Week 52 to Week 148)Reached stopping criteria10
Late Switch Phase (Week 52 to Week 148)Withdrawal by Subject26

Baseline characteristics

CharacteristicDTG + RPVCurrent Antiretroviral Regimen (CAR)Total
Age, Continuous43.3 Years
STANDARD_DEVIATION 11.34
43.2 Years
STANDARD_DEVIATION 9.64
43.3 Years
STANDARD_DEVIATION 10.52
Race/Ethnicity, Customized
African American/ African H. and White
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
11 Participants7 Participants18 Participants
Race/Ethnicity, Customized
Black/African American
13 Participants19 Participants32 Participants
Race/Ethnicity, Customized
Central/South Asian Heritage
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Japanese/East Asian (EA) Heritage (H.)/South EA H.
13 Participants15 Participants28 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White
223 Participants212 Participants435 Participants
Sex: Female, Male
Female
62 Participants57 Participants119 Participants
Sex: Female, Male
Male
199 Participants198 Participants397 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
1 / 2610 / 2552 / 2610 / 2390 / 2080 / 204
other
Total, other adverse events
121 / 261106 / 255170 / 261132 / 2390 / 2080 / 204
serious
Total, serious adverse events
19 / 2619 / 25538 / 26122 / 23912 / 20812 / 204

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 Algorithm94 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm94 Percentage of participants
95% CI: [-3.9, 4.2]
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 Weeks 24 and 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 ClassCHO, Week 48, overall-0.165 mmol/LStandard Deviation 15.9301
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 481.169 mmol/LStandard Deviation 51.9844
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, overall1.015 mmol/LStandard Deviation 15.7472
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, Overall, Week 245.838 mmol/LStandard Deviation 22.9614
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, Overall, Week 486.384 mmol/LStandard Deviation 20.9244
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, Overall, Week 481.137 mmol/LStandard Deviation 23.3849
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, Overall, Week 240.557 mmol/LStandard Deviation 19.4929
DTG + RPVChange From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 24-0.825 mmol/LStandard Deviation 42.5565
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, PI0.936 mmol/LStandard Deviation 11.853
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, PI-1.971 mmol/LStandard Deviation 12.2195
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 484.723 mmol/LStandard Deviation 18.3253
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 24-2.562 mmol/LStandard Deviation 15.3521
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 484.307 mmol/LStandard Deviation 17.8013
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, INSTI, Week 24-3.097 mmol/LStandard Deviation 20.0002
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassHDL CHO direct, INSTI, Week 485.386 mmol/LStandard Deviation 20.6791
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 24-2.031 mmol/LStandard Deviation 15.9582
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 485.140 mmol/LStandard Deviation 17.8779
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 244.395 mmol/LStandard Deviation 21.6685
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 48-0.598 mmol/LStandard Deviation 20.6931
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 245.959 mmol/LStandard Deviation 21.5692
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 480.747 mmol/LStandard Deviation 19.2299
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, INSTI, Week 243.787 mmol/LStandard Deviation 17.6755
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassLDL CHO calculation, INSTI, Week 482.647 mmol/LStandard Deviation 24.043
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 240.983 mmol/LStandard Deviation 24.5052
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 48-6.212 mmol/LStandard Deviation 20.4774
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 249.379 mmol/LStandard Deviation 45.5529
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, Overall, Week 487.183 mmol/LStandard Deviation 44.7044
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, NNRTI, Week 244.962 mmol/LStandard Deviation 40.6201
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, NNRTI, Week 485.248 mmol/LStandard Deviation 41.7728
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, INSTI, Week 2418.204 mmol/LStandard Deviation 47.2348
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, PI, Week 2413.241 mmol/LStandard Deviation 54.2327
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, INSTI, Week 4814.627 mmol/LStandard Deviation 56.2824
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassTriglycerides, PI, Week 485.806 mmol/LStandard Deviation 41.2106
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 24-2.533 mmol/LStandard Deviation 16.3641
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, overall1.300 mmol/LStandard Deviation 12.2269
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, overall0.194 mmol/LStandard Deviation 13.1071
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, NNRTI1.238 mmol/LStandard Deviation 12.4889
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, NNRTI0.281 mmol/LStandard Deviation 12.2469
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 24, INSTI1.973 mmol/LStandard Deviation 12.1365
Current Antiretroviral Regimen (CAR)Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment ClassCHO, Week 48, INSTI2.798 mmol/LStandard Deviation 16.1468
Secondary

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

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

Time frame: At Weeks 4, 24 and 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 48-0.5 Scores on a scaleStandard Deviation 4.33
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 24-1.8 Scores on a scaleStandard Deviation 8.4
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 24-0.7 Scores on a scaleStandard Deviation 4.31
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 48-1.5 Scores on a scaleStandard Deviation 7.97
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 4-2.8 Scores on a scaleStandard Deviation 7.44
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 4-1.1 Scores on a scaleStandard Deviation 4.11
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 4-1.8 Scores on a scaleStandard Deviation 7.24
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 24-0.8 Scores on a scaleStandard Deviation 4.64
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 48-0.4 Scores on a scaleStandard Deviation 4.82
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 4-0.8 Scores on a scaleStandard Deviation 4.02
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 24-1.7 Scores on a scaleStandard Deviation 8.72
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 9.3
p-value: 0.43ANCOVA
p-value: 0.03995% CI: [-2.414, -0.064]ANCOVA
p-value: 0.542ANCOVA
p-value: 0.44895% CI: [-1.896, 0.84]ANCOVA
p-value: 0.402ANCOVA
p-value: 0.16495% CI: [-2.501, 0.426]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

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

Time frame: At Weeks 56, 76, 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 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 56-0.8 Scores on a scaleStandard Deviation 4.8
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 76-0.6 Scores on a scaleStandard Deviation 4.66
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 100-0.5 Scores on a scaleStandard Deviation 5.03
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 148-0.7 Scores on a scaleStandard Deviation 4.87
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 56-1.8 Scores on a scaleStandard Deviation 9.23
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 76-1.6 Scores on a scaleStandard Deviation 8.7
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 100-1.4 Scores on a scaleStandard Deviation 9.4
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 148-1.7 Scores on a scaleStandard Deviation 9.54
Secondary

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

The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 to 6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Time frame: At Weeks 4, 24 and 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 240.0 Score 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 Score 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 Score 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 Score 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 480.0 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score 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 Score on a scale
p-value: 0.037Wilcoxon rank sum test
p-value: 0.101Wilcoxon rank sum test
p-value: 0.042Wilcoxon rank sum test
p-value: 0.132Wilcoxon rank sum test
p-value: 0.022Wilcoxon rank sum test
p-value: 0.004Wilcoxon rank sum test
p-value: 0.076Wilcoxon rank sum test
p-value: 0.073Wilcoxon rank sum test
p-value: 0.547Wilcoxon rank sum test
Secondary

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

The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (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. Change from Baseline is calculated as the value at specified time point minus Baseline value. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis.

Time frame: At Weeks 56, 76, 100 and 148

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 TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 560.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 761.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 1000.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseTotal score, Week 1481.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phaselifestyle/ease Sub-score, Week 560.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phaselifestyle/ease Sub-score, Week 760.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phaselifestyle/ease Sub-score, Week 1000.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phaselifestyle/ease Sub-score, Week 1480.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 560.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 760.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 1000.0 Score on a scale
DTG + RPVChange From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseGeneral Satisfaction/CS, Week 1480.0 Score on a scale
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

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

Time frame: At Weeks 56, 76, 100 and 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 Bother Score, Week 100-0.8 Scores on a scaleStandard Deviation 8.43
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 56-0.9 Scores on a scaleStandard Deviation 4.74
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 76-0.7 Scores on a scaleStandard Deviation 4.29
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 100-0.4 Scores on a scaleStandard Deviation 5.04
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 148-0.6 Scores on a scaleStandard Deviation 4.81
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 56-2.1 Scores on a scaleStandard Deviation 7.56
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 76-1.0 Scores on a scaleStandard Deviation 7.61
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 148-1.0 Scores on a scaleStandard Deviation 8.54
Secondary

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

The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (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. Change from LS Baseline is calculated as the value at specified time point minus LS Baseline value. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis.

Time frame: At Weeks 56, 76, 100 and 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 the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 560.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 760.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 1000.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseTotal score, Week 1480.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phaselifestyle/ease Sub-score, Week 560.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phaselifestyle/ease Sub-score, Week 760.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phaselifestyle/ease Sub-score, Week 1000.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phaselifestyle/ease Sub-score, Week 1480.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 560.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 760.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 1000.0 Score on a scale
DTG + RPVChange From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch PhaseGeneral Satisfaction/CS, Week 1480.0 Score on a scale
Secondary

Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class

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

Time frame: 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 CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassPI10.5 Cells per mm^3Standard Deviation 163.67
DTG + RPVChanges From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassNNRTI49.7 Cells per mm^3Standard Deviation 166.4
DTG + RPVChanges From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassINSTI-11.2 Cells per mm^3Standard Deviation 176.56
Current Antiretroviral Regimen (CAR)Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassNNRTI24.3 Cells per mm^3Standard Deviation 160.32
Current Antiretroviral Regimen (CAR)Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassINSTI10.3 Cells per mm^3Standard Deviation 155.53
Current Antiretroviral Regimen (CAR)Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment ClassPI12.2 Cells per mm^3Standard Deviation 163.32
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. 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 2442.0 Cells per millimeter cube (mm^3)Standard Deviation 172.29
DTG + RPVChanges From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 4828.0 Cells per millimeter cube (mm^3)Standard Deviation 169.35
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 2442.4 Cells per millimeter cube (mm^3)Standard Deviation 164.85
Current Antiretroviral Regimen (CAR)Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48Week 4818.4 Cells per millimeter cube (mm^3)Standard Deviation 159.34
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 biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.

Time frame: 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 48B2M, blood-16.8800 Nanomoles (nmol)/LStandard Deviation 34.8933
DTG + RPVMean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 4825 hydroxy-vitamin D, blood-13.9 Nanomoles (nmol)/LStandard Deviation 25.3
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-173.2820 Nanomoles (nmol)/LStandard Deviation 1311.24142
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-6.8123 Nanomoles (nmol)/LStandard Deviation 24.0965
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-0.0631 Nanomoles (nmol)/LStandard Deviation 11.99886
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 48B2M, blood-4.7501 Nanomoles (nmol)/LStandard Deviation 43.04355
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 B2M62.3209 Nanomoles (nmol)/LStandard Deviation 391.32049
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 4825 hydroxy-vitamin D, blood-9.2 Nanomoles (nmol)/LStandard Deviation 19.55
p-value: 0.007ANCOVA
p-value: 0.01195% CI: [0.767, 0.967]ANCOVA
p-value: 0.74595% CI: [0.943, 1.085]ANCOVA
p-value: 0.01895% CI: [0.787, 0.977]ANCOVA
Secondary

Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.

Time frame: 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 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Procollagen type 1 N-propeptide-5.8 Microgram (ug)/LStandard Deviation 20
DTG + RPVMean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Type I Collagen C-Telopeptides-0.15 Microgram (ug)/LStandard Deviation 0.313
DTG + RPVMean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Osteocalcin-5.11 Microgram (ug)/LStandard Deviation 7.334
DTG + RPVMean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48sVCAM-2.63 Microgram (ug)/LStandard Deviation 571.182
DTG + RPVMean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Bone-specific alkaline phosphatase-3.18 Microgram (ug)/LStandard Deviation 5.678
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48sVCAM37.42 Microgram (ug)/LStandard Deviation 617.486
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Bone-specific alkaline phosphatase0.92 Microgram (ug)/LStandard Deviation 4.634
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Procollagen type 1 N-propeptide0.3 Microgram (ug)/LStandard Deviation 19.28
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Osteocalcin-1.14 Microgram (ug)/LStandard Deviation 6.017
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48Type I Collagen C-Telopeptides-0.09 Microgram (ug)/LStandard Deviation 0.344
p-value: 0.001ANCOVA
p-value: <0.00195% CI: [0.686, 0.773]ANCOVA
p-value: 0.00495% CI: [0.785, 0.954]ANCOVA
p-value: <0.00195% CI: [0.719, 0.864]ANCOVA
p-value: 0.677ANCOVA
p-value: <0.00195% CI: [0.823, 0.914]ANCOVA
p-value: <0.001ANCOVA
p-value: <0.00195% CI: [0.799, 0.91]ANCOVA
p-value: 0.02895% CI: [0.796, 0.987]ANCOVA
p-value: <0.00195% CI: [0.672, 0.822]ANCOVA
p-value: 0.782ANCOVA
p-value: <0.00195% CI: [0.751, 0.891]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 48-0.02 mg/LStandard Deviation 0.11
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Cystatin C at Week 48-0.01 mg/LStandard Deviation 0.108
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 480.01 Nanomole/L fibrinogen equivalent unitsStandard Deviation 1.629
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in D-Dimer at Week 48-0.13 Nanomole/L fibrinogen equivalent unitsStandard Deviation 2.932
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 Weeks 24 and 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 24-0.015 Millimoles (mmol)/LStandard Deviation 0.7539
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 48-0.079 Millimoles (mmol)/LStandard Deviation 0.7926
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 240.085 Millimoles (mmol)/LStandard Deviation 0.594
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 48-0.049 Millimoles (mmol)/LStandard Deviation 0.6276
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 24-0.024 Millimoles (mmol)/LStandard Deviation 0.2365
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 480.051 Millimoles (mmol)/LStandard Deviation 0.2386
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 24-0.184 Millimoles (mmol)/LStandard Deviation 1.0102
DTG + RPVMean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 48-0.169 Millimoles (mmol)/LStandard Deviation 1.0062
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 48-0.021 Millimoles (mmol)/LStandard Deviation 1.0156
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 240.020 Millimoles (mmol)/LStandard Deviation 0.5777
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 24-0.051 Millimoles (mmol)/LStandard Deviation 0.2258
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Total cholesterol, Week 48-0.038 Millimoles (mmol)/LStandard Deviation 0.6148
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48Triglycerides, Week 240.040 Millimoles (mmol)/LStandard Deviation 0.9164
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 240.055 Millimoles (mmol)/LStandard Deviation 0.5232
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48HDL cholesterol direct, Week 480.049 Millimoles (mmol)/LStandard Deviation 0.2489
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48LDL cholesterol calculation, Week 48-0.076 Millimoles (mmol)/LStandard Deviation 0.528
Secondary

Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.

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 CD14 at Week 48FABP-1.50 Nanogram/milliliterStandard Deviation 1.278
DTG + RPVMean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48Soluble CD14456.69 Nanogram/milliliterStandard Deviation 731.833
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48FABP-0.99 Nanogram/milliliterStandard Deviation 1.441
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48Soluble CD14802.26 Nanogram/milliliterStandard Deviation 878.304
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 480.10 mg/Liter (L)Standard Deviation 5.383
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 480.80 mg/Liter (L)Standard Deviation 8.527
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, 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 480.50 HOMA-IR ScoreStandard Deviation 4.78
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 480.80 HOMA-IR ScoreStandard Deviation 3.938
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 points were analyzed.

ArmMeasureValue (MEAN)Dispersion
DTG + RPVMean Change From Baseline in Interleukin 6 (IL-6) at Week 48-0.08 Nanograms (ng)/LStandard Deviation 2.373
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48-0.07 Nanograms (ng)/LStandard Deviation 2.761
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 0.825
DTG + RPVMean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Serum creatinine0.100 mg/deciliter (dL)Standard Deviation 0.1053
DTG + RPVMean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Glucose0.187 mg/deciliter (dL)Standard Deviation 19.5808
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48RBP0.00 mg/deciliter (dL)Standard Deviation 0.872
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Serum creatinine-0.003 mg/deciliter (dL)Standard Deviation 0.0847
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48Glucose3.220 mg/deciliter (dL)Standard Deviation 10.0987
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 CD16365.38 Microgram(µg)/LiterStandard Deviation 180.869
DTG + RPVMean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Oxidized LDL60.87 Microgram(µg)/LiterStandard Deviation 504.345
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Soluble CD16353.94 Microgram(µg)/LiterStandard Deviation 215.621
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48Oxidized LDL13.92 Microgram(µg)/LiterStandard Deviation 575.305
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-0.78 Grams (g)/molStandard Deviation 5.116
DTG + RPVMean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine protein/creatinine ratio-2.73 Grams (g)/molStandard Deviation 12.683
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine albumin/creatinine ratio-0.64 Grams (g)/molStandard Deviation 9.538
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48Urine protein/creatinine ratio1.23 Grams (g)/molStandard Deviation 5.088
Secondary

Mean Change From Baseline in Urine Phosphate at Week 48

Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Time frame: 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 481.335 Millimoles (mmol)/LStandard Deviation 16.7211
Current Antiretroviral Regimen (CAR)Mean Change From Baseline in Urine Phosphate at Week 48-0.798 Millimoles (mmol)/LStandard Deviation 15.3771
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 (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.

Time frame: Up to 48 weeks

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 ClassAny AE, NNRTI106 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, INSTI47 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, PI42 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 AE68 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 AE30 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 AE8 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 AE0 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 ClassINSTI, Maximum toxicity Grade 1 AE27 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 ClassINSTI, Maximum toxicity Grade 2 AE15 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 ClassINSTI, 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 ClassINSTI, Maximum toxicity Grade 4 AE0 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 AE24 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 AE14 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 AE3 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 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 ClassAELD, NNRTI5 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, INSTI4 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, PI3 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 AE3 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, NNRTI96 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 ClassINSTI, Maximum toxicity Grade 3 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 ClassAny AE, INSTI36 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, PI0 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, PI42 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 ClassINSTI, 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 ClassNNRTI, Maximum toxicity Grade 1 AE76 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 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 ClassNNRTI, Maximum toxicity Grade 2 AE19 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 AE26 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 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 ClassAELD, INSTI0 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 ClassPI, Maximum toxicity Grade 2 AE13 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 ClassINSTI, 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 ClassAELD, NNRTI1 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 ClassINSTI, Maximum toxicity Grade 2 AE15 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 use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with \>5% incidence for either treatment.

Time frame: Up to Week 410 or study discontinuation

Population: Safety Population included all randomized participants who 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 AE78 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 AE33 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 SAE50 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 AE13 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 AE104 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)AELD23 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 AE166 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)AELD8 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 AE132 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 SAE32 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 AE85 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 AE95 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 AE29 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 AE11 Participants
Secondary

Number of Participants With Genotypic Resistance-CAR Arm 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 is 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 Arm Through Late Switch PhaseINI, DTG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, EVG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, EVG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, EVG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, RAL, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, RAL, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseINI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, DLV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, EFV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, EFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, EFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, EFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, EFV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, ETR, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, ETR, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, ETR, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, ETR, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, ETR, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, NVP, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, NVP, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, NVP, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, NVP, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, RPV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, RPV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, RPV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNNRTI, RPV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, 3TC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, 3TC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ABC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ABC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, FTC, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, FTC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, TDF, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, TDF, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ZDV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ZDV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ZDV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, d4T, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, d4T, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, d4T, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ddI, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhaseNRTI, ddI, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, ATV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, DRV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, FPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, IDV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, LPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, LPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, NFV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, NFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, RTV, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, SQV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, TPV/r, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Arm Through Late Switch PhasePI, TPV/r, High-level resistance0 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 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 410

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 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 resistance0 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 resistance1 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 resistance0 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 resistance1 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 resistance0 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 resistance1 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 resistance0 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
DTG + RPVNumber of Participants With Genotypic Resistance-CAR Group Through Continuation PhaseNNRTI, RPV, High-level resistance1 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
Secondary

Number of Participants With Genotypic Resistance-DTG+RPV Arm 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 Confirmed Virologic Withdrawal 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 Arm Through Early and Late Switch PhasePI, RTV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, DTG, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, EVG, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, EVG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, EVG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, EVG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, EVG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, RAL, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, RAL, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, RAL, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, RAL, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseINI, RAL, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, DLV, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, DLV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, DLV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, DLV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, DLV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, EFV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, EFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, ETR, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, EFV, Low-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, EFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, EFV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, ETR, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, ETR, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, ETR, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, ETR, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, NVP, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, NVP, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, NVP, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, NVP, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, NVP, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, RPV, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, RPV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, RPV, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNNRTI, RPV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, 3TC, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, 3TC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, 3TC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, 3TC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, 3TC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ABC, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ABC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ABC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ABC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ABC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, FTC, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, FTC, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, FTC, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, FTC, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, FTC, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, TDF, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, TDF, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, TDF, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, TDF, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, TDF, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ZDV, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ZDV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ZDV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ZDV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ZDV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, d4T, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, d4T, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, d4T, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, d4T, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, d4T, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ddI, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ddI, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ddI, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ddI, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhaseNRTI, ddI, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, ATV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, ATV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, ATV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, ATV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, ATV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, DRV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, DRV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, DRV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, DRV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, FPV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, FPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, FPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, FPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, IDV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, IDV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, IDV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, IDV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, IDV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, LPV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, LPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, LPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, LPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, LPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, NFV, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, NFV, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, NFV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, NFV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, NFV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, RTV, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, RTV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, RTV, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, RTV, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, SQV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, SQV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, SQV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, SQV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, TPV/r, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, TPV/r, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, TPV/r, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch PhasePI, TPV/r, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and 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 410

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, 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, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, DTG, Susceptible2 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, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, EVG, Potential low-level resistance0 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, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseINI, RAL, Potential low-level resistance0 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 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, Susceptible0 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 resistance0 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, Susceptible0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Potential low-level resistance0 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, NVP, Susceptible0 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 resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Susceptible0 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, RPV, High-level resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, 3TC, Susceptible2 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 resistance0 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, Susceptible2 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, FTC, Susceptible2 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 resistance0 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, Susceptible2 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ZDV, Potential low-level resistance0 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Susceptible2 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, d4T, Potential low-level resistance0 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhaseNRTI, ddI, Susceptible2 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 resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Susceptible2 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, Susceptible2 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, DRV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, FPV/r, Susceptible2 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, FPV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, IDV/r, Susceptible2 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, 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, Susceptible2 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, Susceptible2 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 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, Susceptible2 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, Susceptible2 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, SQV/r, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation PhasePI, TPV/r, Susceptible2 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
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 \[DTG\]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented.

Time frame: Up to Week 48

Population: The analysis was performed on the CVW resistance Population which was comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseINSTI, DTG, Susceptible1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseINSTI, DTG, Potential low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseINSTI, DTG, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseINSTI, DTG, Intermediate resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseINSTI, DTG, High-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseNNRTI, RPV, Susceptible0 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 PhaseNNRTI, RPV, Low-level resistance0 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseNNRTI, RPV, Intermediate resistance1 Participants
DTG + RPVNumber of Participants With Genotypic Resistance-Early Switch PhaseNNRTI, RPV, High-level 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 the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.

Time frame: Up to 48 weeks

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 192 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 272 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 311 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 41 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 410 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 180 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 316 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 WeeksGrade 279 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 at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.

Time frame: Up to 48 weeks

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 151 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 231 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 37 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassNNRTI, Grade 41 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, Grade 119 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, Grade 223 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, Grade 33 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, Grade 40 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 122 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 218 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassPI, Grade 31 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 152 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, Grade 33 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 240 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 221 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 34 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, 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 45 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 43 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, 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 117 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINSTI, Grade 218 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 the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.

Time frame: Up to 48 weeks

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 22 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 41 Participants
Current Antiretroviral Regimen (CAR)Number 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 111 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 WeeksGrade 30 Participants
Current Antiretroviral Regimen (CAR)Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 WeeksGrade 22 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 at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.

Time frame: Up to 48 weeks

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 17 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 41 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 11 Participants
DTG + RPVNumber of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment ClassINI; Grade 20 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 13 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 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 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 22 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 20 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 30 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 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 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 11 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 14 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.

Time frame: Week 48

Population: CVW resistance Population. 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.

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 (NNRTI) were summarized.

Time frame: Week 52 to Week 410

Population: The analysis was 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 PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 PhaseNNRTI, NNRTI, ETR, Intermediate 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 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, NRTI, 3TC, 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 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 PhaseNNRTI, 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 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR 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 CAR Group Through Continuation PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, TPV/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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, NCP, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 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 CAR Group Through Continuation PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NRTI, ddI, 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) were summarized.

Time frame: Up to Week 410

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, 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, INI, DTG, 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, 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, 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, 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, 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, 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, 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, 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, Susceptible0 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, Susceptible0 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 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, NVF, Susceptible0 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, NVF, 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, NVF, 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, NVF, 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, NVF, 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, Susceptible0 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 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, 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, Susceptible0 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 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, 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 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, 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 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, 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, 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, ZDF, 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, ZDF, 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, ZDF, 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, ZDF, 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, ZDF, 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, d4T, 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, 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-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 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, PI, ATV/r, 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, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, PI, DRV/r, 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, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, PI, FPV/r, 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, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, PI, IDV/r, 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, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, PI, LPV/r, 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, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, PI, NFV, 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, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, 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-DTG+RPV Group Through Continuation PhaseNNRTI, PI, RTV, 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, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, SQV/r, 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, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, TPV/r, 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, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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.

Time frame: Week 48

Population: CVW resistance Population. 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.

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 (NNRTI) were summarized.

Time frame: Week 52 to Week 410

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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, ETR, Partially 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 PhaseNNRTI, NNRTI, ETR, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, RPV, 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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, RPV, 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 PhaseNNRTI, NRTI, 3TC, Reistant0 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, SQV/r, Partiallly 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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) were summarized.

Time frame: Up to Week 410

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 PhaseNNRTI, INI, RAL, Resistant1 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, INI, RAL, 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 PhaseNNRTI, NNRTI, DLV, Resistant1 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, EFV, Resistant1 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, ETR, Resistant1 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NNRTI, RPV, Resistant1 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NRTI, 3TC, Reistant0 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, NRTI, ZDF, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, LPV/r, yResistant0 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, SQV/r, Partiallly 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, 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 PhaseNNRTI, PI, TPV/r, Sensitive2 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: 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 410

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 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 Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance- CAR Group Through Continuation PhaseNNRTI, ETR, Sensitive0 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, Resistant1 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, Sensitive0 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, Partially Sensitive0 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 (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.

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

Population: LS CVW resistance Population

ArmMeasureGroupValue (COUNT_OF_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, SQV/r, Resistant0 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 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 sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-CAR Group Through Late Switch PhaseNNRTI, ETR, Sensitive0 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, Resistant1 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, Sensitive0 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, 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, Resistant0 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 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, 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 410

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, EVG, Sensitive1 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, Sensitive1 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, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhaseNNRTI, ETR, Sensitive1 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, Sensitive1 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, Sensitive1 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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 PhasePI, DRV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, DRV/r, Sensitive2 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, 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, Sensitive2 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, Sensitive2 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, Sensitive2 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 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, Sensitive1 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, RAL, Resistant1 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, Sensitive0 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 PhaseNRTI, d4T, Sensitive2 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, Sensitive2 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 PhasePI, ATV/r, Partially Sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation PhasePI, ATV/r, Sensitive2 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, FPV/r, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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. Only those participants with data available at the specified time points were analyzed.

ArmMeasureGroupValue (COUNT_OF_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, Sensitive1 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, Sensitive1 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, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseINI, RAL, Resistant1 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, Sensitive0 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, Sensitive1 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, Sensitive1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Resistant1 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Partially sensitive0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch PhaseNNRTI, ETR, Sensitive1 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, Sensitive1 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 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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, Sensitive2 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: The analysis was performed on the CVW resistance Population which was comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met. Only participants from the DTG + RPV were analyzed as the CAR participants did not receive study treatment until Week 52.

ArmMeasureGroupValue (COUNT_OF_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 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 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, NVP, Resistant0 Participants
DTG + RPVNumber of Participants With Phenotypic Resistance-Early Switch PhaseNNRTI, NVP, 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, 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, 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 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, 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 PhasePI, ATV/r, Resistant0 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, DRV/r, Sensitive1 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, 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
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
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 Algorithm97 Percentage of participants
Current Antiretroviral Regimen (CAR)Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm98 Percentage of participants
95% CI: [-4, 1.8]
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 (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.

Time frame: At 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 ClassNNRTI97 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 ClassINSTI92 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 ClassPI91 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 ClassNNRTI93 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 ClassINSTI94 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 ClassPI97 Percentage of participants
p-value: 0.179Chi-squared, Corrected
95% CI: [-1.6, 8.6]
95% CI: [-12.1, 7.4]
95% CI: [-13.9, 3.1]
Secondary

Pre-dose Concentrations of DTG and RPV 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 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 in Participants Switching to DTG + RPV - CAR Group Through Late Switch PhaseWeek 561544.75 ug/ LStandard Deviation 1049.595
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch PhaseWeek 761806.77 ug/ LStandard Deviation 1019.3
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch PhaseWeek 1001881.97 ug/ LStandard Deviation 1160.587
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch PhaseWeek 5677.27 ug/ LStandard Deviation 38.931
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch PhaseWeek 7691.46 ug/ LStandard Deviation 48.568
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch PhaseWeek 10090.89 ug/ LStandard Deviation 47.762
Secondary

Pre-dose Concentrations of DTG and RPV 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 in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 41578.88 ug/ LStandard Deviation 1170.967
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 241447.23 ug/ LStandard Deviation 917.677
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 481384.36 ug/ LStandard Deviation 889.829
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 561637.74 ug/ LStandard Deviation 1063.391
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 761507.81 ug/ LStandard Deviation 913.263
DTG + RPVPre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 1001532.10 ug/ LStandard Deviation 916.975
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 7692.51 ug/ LStandard Deviation 46.223
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 479.50 ug/ LStandard Deviation 38.23
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 5690.55 ug/ LStandard Deviation 45.686
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 2490.21 ug/ LStandard Deviation 46.302
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 10091.98 ug/ LStandard Deviation 44.683
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch PhaseWeek 4891.41 ug/ LStandard Deviation 47.073
Secondary

Pre-dose Concentrations of DTG and RPV 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 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.

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

Population: PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
DTG + RPVPre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVWeek 2834.58 ug/ LStandard Deviation 639.622
DTG + RPVPre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVWeek 41218.23 ug/ LStandard Deviation 842.703
DTG + RPVPre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVWeek 81472.50 ug/ LStandard Deviation 818.774
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVWeek 257.342 ug/ LStandard Deviation 29.5436
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVWeek 478.338 ug/ LStandard Deviation 31.4825
Current Antiretroviral Regimen (CAR)Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPVWeek 879.652 ug/ LStandard Deviation 40.7546
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 10055.9 Cells/mm^3Standard Deviation 202.56
DTG + RPVChange From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch PhaseWeek 14851.5 Cells/mm^3Standard Deviation 205.98
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: LS Baseline (Week 48), 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 10020.9 Cells/mm^3Standard Deviation 173.39
DTG + RPVChange From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch PhaseWeek 1486.5 Cells/mm^3Standard Deviation 167.44
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: 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 10097 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 14893 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: 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 10089 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 14884 Percentage of participants

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