NCT02071082

Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV
• HBV

Interventions

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

Timeline

• Start date: 2014-02-25
• Primary completion: 2015-01-23
• Completion: 2016-10-26
• First posted: 2014-02-25
• Last updated: 2018-11-16
• Results posted: 2016-04-04

Locations

24 sites across 3 countries: United States, Canada, Japan