At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 472 enrolled

Drug / intervention

E/C/F/TAF +5 moredrug

Likely dose

E/C/F/TAF 10 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/NCT02652624

NCT02652624Phase 3Completed

Compare CT.gov

A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women

Gilead Sciences·interventional·Posted Jan 12, 2016·Updated Mar 4, 2020

In Brief

A Phase 3 clinical trial evaluating E/C/F/TAF, E/C/F/TDF, and 4 other interventions for HIV-1 Infection. Completed, enrolled 472 participants across 56 sites in 6 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV-1 Infection

CountriesDominican Republic, Puerto Rico, Russia, Thailand, Uganda, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedJan 2016

Enrollment StartFeb 2016

Primary CompletionOct 2017

Study CompletionNov 2018

TodayJul 2026

First PostedJan 12, 2016

Enrollment StartFeb 19, 2016

Primary CompletionOct 9, 2017

Study CompletionNov 26, 2018

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 10.5 years ago

Interventions

E/C/F/TAFdrug

150/150/200/10 mg FDC tablet administered orally once daily with food

E/C/F/TDFdrug

150/150/200/300 mg FDC administered orally once daily with food

ATVdrug

ATV 300 mg capsules administered orally once daily with food

RTVdrug

RTV 100 mg tablets administered orally once daily with food

FTC/TDFdrug

200/300 mg tablet administered orally once daily with food

B/F/TAFdrug

50/200/25 mg FDC tablet administered orally once daily without regard to food