Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
Name: Dolutegravir / Lamivudine Pill
Name: Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill
Description: percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm
Measure: The Primary outcome measure is to evaluate the efficacy of switching from B/F/TAF to DTG/3TC versus continuing B/F/TAF as determined by the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 Time: 48 weeksDescription: percentage with HIV-1 RNA ≥50 copies/mL at Weeks 12 and 24 in each treatment arm
Measure: The Secondary outcome measure is to evaluate the efficacy of switching to DTG/3TC from B/F/TAF as determined by the proportion of participants with HIV-1 RNA≥ 50 copies/mL at Weeks 12 and 24 Time: 12 and 24 weeksDescription: percentage with HIV-1 RNA<50 copies/mL at Weeks 12, 24 and 48 in each treatment arm
Measure: The secondary outcome measure is to evaluate the efficacy of switching to DTG/3TC from B/F/TAF as determined by the proportion of participants with HIV-1 RNA<50 copies/mL at Weeks 12, 24 and 48 Time: 12, 24 and 48 weeksDescription: AEs and lab abnormalities graded using DAIDS grading scale
Measure: The secondary outcome measure is to measure the Incidence and severity of adverse events and laboratory abnormalities (graded using DAIDs grading scale) through 48 weeks Time: 48 weeksDescription: Number of participants who discontinue study treatment and reasons for discontinuation
Measure: The secondary outcome measure is to evaluate the proportion of participants that discontinue treatment through 48 weeks in each treatment arm and reasons for discontinuation Time: 48 weeksDescription: Change from Baseline in fasting lipids at Weeks 24, and 48
Measure: The secondary outcome measure is to evaluate the effects of DTG/3TC once daily on fasting lipids over time compared to B/F/TAF through 48 weeks Time: 48 weeksDescription: Change from Baseline in weight (kg) measured at Weeks 12, 24, and 48
Measure: The secondary outcome measure is to evaluate changes in weight (kg) in those treated with DTG/3TC vs. B/F/TAF over time Time: 12, 24 and 48 weeksDescription: Change from Baseline in waist circumference (measured in inches) at Weeks 12, 24, and 48
Measure: The secondary outcome measure is to evaluate changes in waist circumference (inches) in those treated with DTG/3TC vs. B/F/TAF over time Time: 12, 24 and 48 weeksDescription: Change from Baseline in weight (kg) and height (meters) will be used to assess changes in BMI (kg/m2) measured at Weeks 12, 24, and 48
Measure: The secondary outcome measure is to evaluate changes in BMI (kg/m2) in those treated with DTG/3TC vs. B/F/TAF over time Time: 12, 24 and 48 weeksDescription: Change from Baseline in health status using the HIV-Symptoms Index questionnaire (validated 20-item questionnaire which asks subjects to rate the degree of bother they experience for each symptom in the past two weeks, the rating scale for each item ranges from 0-4 with higher values indicating greater symptom distress). This questionnaire will be administered on paper at Weeks 4, 12, 24 and 48 (or Withdrawal from the study)
Measure: The secondary outcome measure is to assess health related quality of life for subjects treated with DTG/3TC compared to B/F/TAF over time using the HIV-Symptoms Index questionnaire Time: 4, 12, 24 and 48 weeks (or at study withdrawal)Description: Change from baseline in treatment satisfaction using the HIV Treatment Satisfaction Questionnaire (validated 10-item questionnaire which asks subjects to rate how satisfied they are with different aspects of their HIV treatment, each item utilizes a rating scale of 0-6 with higher numbers indicating greater satisfaction). This survey will be administered on paper at Weeks 4, and 24 (or withdrawal from the study)
Measure: To assess treatment satisfaction in subjects treated with DTG/3TC compared to B/F/TAF over time using the HIV-Treatment Satisfaction Questionnaire Time: 4 and 24 weeks (or at study withdrawal)Description: to measure the incidence of observed genotypic resistance to ARVs for subjects meeting Virologic Rebound Criteria
Measure: To assess the number of subjects with genotypic mutations affecting any component of the treatment regimen among subjects meeting Virologic Rebound Criteria (HIV-1 RNA≥50 copies/mL X2) using HIV genotypic and ARCHIVE HIV-DNA testing Time: 48 weeksAllocation: Randomized
Parallel Assignment
There are 8 SNPs
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q --- --- M184V --- --- K65R ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R --- --- L210W ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q --- --- M184V ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L ---
Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---