NCT01797445

Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 872 (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 (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

Conditions

• HIV
• HIV Infections

Interventions

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

Timeline

• Start date: 2013-03-12
• Primary completion: 2014-09-19
• Completion: 2018-10-03
• First posted: 2013-02-22
• Last updated: 2020-03-02
• Results posted: 2016-01-08

Locations

117 sites across 11 countries: United States, Canada, Dominican Republic, France, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study