At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 28 enrolled
Drug / intervention
B/F/TAFdrug
Likely dose
B/F/TAF 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection
In Brief
A Phase 4 clinical trial evaluating B/F/TAF for HIV-1-infection and Hepatitis B. Completed, enrolled 28 participants across 2 sites.
Detailed Summary
The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection, Hepatitis B
CountriesUnited States
CollaboratorsGilead Sciences
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartApr 2019
Primary CompletionNov 2022
Study CompletionMay 2023
TodayJul 2026
First PostedJan 8, 2019
Enrollment StartApr 30, 2019
Primary CompletionNov 22, 2022
Study CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.5 years ago
Interventions
B/F/TAFdrug
Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.