CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 567 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/NCT03110380
NCT03110380Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

Gilead Sciences·interventional·Posted Apr 12, 2017·Updated Jan 11, 2022

In Brief

A Phase 3 clinical trial evaluating B/F/TAF, F/TAF, and 4 other interventions for HIV-1-infection. Completed, enrolled 567 participants across 94 sites in 6 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesAustria, Canada, France, Germany, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 12, 2017
Enrollment StartJun 12, 2017
Primary CompletionDec 4, 2018
Study CompletionFeb 10, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.2 years ago

Interventions

B/F/TAFdrug

50/200/25 mg FDC tablet(s) administered orally once daily

F/TAFdrug

200/25 mg FDC tablet(s) administered orally once daily

DTGdrug

50 mg tablet(s) administered orally once daily

DTG Placebodrug

Tablet(s) administered orally once daily

F/TAF Placebodrug

Tablet(s) administered orally once daily

B/F/TAF Placebodrug

Tablet(s) administered orally once daily