At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 79 enrolled

Drug / intervention

E/C/F/TAFdrug

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/NCT02071082

NCT02071082Phase 3Completed

Compare CT.gov

A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults

Gilead Sciences·interventional·Posted Feb 25, 2014·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating E/C/F/TAF for HIV and HBV. Completed, enrolled 79 participants across 24 sites in 3 countries.

Detailed Summary

This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive * Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV, HBV

CountriesCanada, Japan, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedFeb 2014

Enrollment StartFeb 2014

Primary CompletionJan 2015

Study CompletionOct 2016

TodayJul 2026

First PostedFeb 25, 2014

Enrollment StartFeb 25, 2014

Primary CompletionJan 23, 2015

Study CompletionOct 26, 2016

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 12.4 years ago

Interventions

E/C/F/TAFdrug

E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food