CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
BIC +5 moredrug
Likely dose
BIC 75 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/NCT02397694
NCT02397694Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences·interventional·Posted Mar 25, 2015·Updated Apr 7, 2020

In Brief

A Phase 2 clinical trial evaluating BIC, F/TAF, and 4 other interventions for HIV-1 Infection. Completed, enrolled 98 participants across 21 sites.

Detailed Summary

This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 25, 2015
Enrollment StartMar 23, 2015
Primary CompletionNov 30, 2015
Study CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.3 years ago

Interventions

BICdrug

75 mg tablet administered orally once daily

F/TAFdrug

200/25 mg FDC tablet administered orally once daily

DTGdrug

50 mg tablet administered orally once daily

BIC Placebodrug

Tablet administered orally once daily

DTG Placebodrug

Tablet administered orally once daily

B/F/TAFdrug

50/200/25 mg FDC tablet administered orally once daily