CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 244 enrolled
Drug / intervention
B/F/TAF +5 moredrug
Likely dose
B/F/TAF 25 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.

Search/NCT03547908
NCT03547908Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

Gilead Sciences·interventional·Posted Jun 6, 2018·Updated Mar 19, 2025

In Brief

A Phase 3 clinical trial evaluating B/F/TAF, Placebo to match DTG, and 4 other interventions for HIV-1/HBV Co-Infection. Completed, enrolled 244 participants across 69 sites in 14 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1/HBV Co-Infection
CountriesChina, Dominican Republic, France, Greece, Hong Kong, Japan, Malaysia, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartMay 30, 2018
Primary CompletionFeb 25, 2022
Study CompletionMar 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.1 years ago

Interventions

B/F/TAFdrug

50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food

Placebo to match DTGdrug

Tablet administered orally once daily, without regard to food

Placebo to match F/TDFdrug

Tablet administered orally once daily, without regard to food

DTGdrug

50 mg tablet administered orally once daily, without regard to food

F/TDFdrug

200/300 mg tablet administered orally once daily, without regard to food

Placebo to match B/F/TAFdrug

Tablet administered orally once daily, without regard to food