CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 657 enrolled
Drug / intervention
DTG +5 moredrug
Likely dose
DTG 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.

Search/NCT02607956
NCT02607956Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate 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 Nov 18, 2015·Updated Mar 7, 2022

In Brief

A Phase 3 clinical trial evaluating DTG, F/TAF, and 4 other interventions for HIV-1 Infection. Completed, enrolled 657 participants across 125 sites in 11 countries.

Detailed Summary

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesAustralia, Belgium, Canada, Dominican Republic, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 18, 2015
Enrollment StartNov 11, 2015
Primary CompletionMay 12, 2017
Study CompletionJul 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.6 years ago

Interventions

DTGdrug

50 mg tablets administered orally, once daily

F/TAFdrug

200/25 mg tablets administered orally, once daily

B/F/TAFdrug

50/200/25 milligrams (mg) FDC tablets administered orally, once daily

DTG Placebodrug

Tablets administered orally, once daily

F/TAF Placebodrug

Tablets administered orally, once daily

B/F/TAF Placebodrug

Tablets administered orally, once daily