drugset / Trial / NCT02071082

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

NCT02071082

Phase 3 Completed 79 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2014-02-25
Primary completion
2015-01-23
Completion
2016-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobicistat Small molecule 150 mg Oral
Subject elvitegravir Small molecule 150 mg Oral
Subject emtricitabine Other / unclassified 200 mg Oral
Subject tenofovir alafenamide Small molecule 10 mg Oral