NCT01497899

Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Conditions

• Acquired Immunodeficiency Syndrome
• HIV Infections

Interventions

Type	Name	Description
DRUG	E/C/F/TDF	150/150/200/300 mg FDC tablet administered orally once daily
DRUG	E/C/F/TAF Placebo	Tablet administered orally once daily
DRUG	E/C/F/TAF	150/150/200/10 mg FDC tablet administered orally once daily
DRUG	E/C/F/TDF Placebo	Tablet administered orally once daily

Timeline

• Start date: 2011-12-28
• Primary completion: 2012-10-17
• Completion: 2016-08-22
• First posted: 2011-12-23
• Last updated: 2018-11-19
• Results posted: 2016-01-08

Locations

41 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study