Phase 4
N=222
Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF
HIV I Infection
Bottom Line
View on ClinicalTrials.gov: NCT04585737 ↗Enrolled (actual)
222
Serious AEs
7.2%
Results posted
Oct 2024
Primary outcome: Primary: 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 — 6; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dolutegravir / Lamivudine Pill (Drug); Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Charlotte-Paige Rolle, MD
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
6; 5 | — |
| SECONDARY 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 Week 24 |
3; 3 | — |
| SECONDARY 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 Week 48 |
127; 59 | — |
| SECONDARY The Secondary Outcome Measure is to Measure the Incidence and Severity of Grade 2-5 Drug-related Adverse Events and Laboratory Abnormalities (Graded Using DAIDs Grading Scale) Through 48 Weeks |
14; 1 | — |
| SECONDARY 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 |
15; 9 | — |
| SECONDARY The Secondary Outcome Measure is to Evaluate the Effects of DTG/3TC Once Daily on Fasting Total Cholesterol Over Time Compared to B/F/TAF Through 48 Weeks |
-2.3; 3.3 | — |
| SECONDARY The Secondary Outcome Measure is to Evaluate Changes in Weight (kg) in Those Treated With DTG/3TC vs. B/F/TAF Over Time |
-1; 0.2 | — |
| SECONDARY The Secondary Outcome Measure is to Evaluate Changes in Waist Circumference (Inches) in Those Treated With DTG/3TC vs. B/F/TAF Over Time |
-0.9; -0.7 | — |
| SECONDARY The Secondary Outcome Measure is to Evaluate Changes in BMI (kg/m2) in Those Treated With DTG/3TC vs. B/F/TAF Over Time |
-0.6; -0.1 | — |
| SECONDARY 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 |
2; 1 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria -
- Aged 18 years or older at the time of signing the informed consent
TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- HIV-1 infected men or women.
- Must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
- Documented evidence of at least two plasma HIV-1 RNA measurements 35% direct bilirubin).
- Creatinine clearance of 200 c/mL.
- Within the 6 to 12-month window prior to Screening and after confirmed suppression to <50 copies/mL, 2 or more plasma HIV-1 RNA measurements ≥50 c/mL.
- 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 copies/mL.
- Any drug holiday during the 12 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 history of switch to another 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 ≥400 copies/mL.
Data sourced from ClinicalTrials.gov (NCT04585737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.