CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 631 enrolled
Drug / intervention
ABC/DTG/3TC +3 moredrug
Likely dose
ABC/DTG/3TC 300 milligramsfrom 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/NCT02607930
NCT02607930Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences·interventional·Posted Nov 18, 2015·Updated Mar 2, 2022

In Brief

A Phase 3 clinical trial evaluating ABC/DTG/3TC, B/F/TAF, and 2 other interventions for HIV-1 Infection. Completed, enrolled 631 participants across 121 sites in 10 countries.

Detailed Summary

The 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 a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 18, 2015
Enrollment StartNov 13, 2015
Primary CompletionMay 9, 2017
Study CompletionJul 2, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.6 years ago

Interventions

ABC/DTG/3TCdrug

600/50/300 milligrams (mg) tablets administered orally, once daily

B/F/TAFdrug

50/200/25 mg tablets administered orally, once daily, without regard to food

ABC/DTG/3TC Placebodrug

Tablets administered orally, once daily

B/F/TAF Placebodrug

Tablets administered orally, once daily