NCT01565850

D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.

Conditions

• Acquired Immunodeficiency Syndrome
• HIV Infections

Interventions

Type	Name	Description
DRUG	D/C/F/TAF	DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily
DRUG	DRV	DRV 800 mg (2 × 400 mg tablets) administered orally once daily
DRUG	COBI	COBI 150 mg tablet administered orally once daily
DRUG	FTC/TDF	FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily
DRUG	D/C/F/TAF Placebo	D/C/F/TAF placebo tablet administered orally once daily
DRUG	DRV Placebo	DRV placebo tablet administered orally once daily
DRUG	COBI Placebo	COBI placebo tablet administered orally once daily
DRUG	FTC/TDF Placebo	FTC/TDF placebo tablet administered orally once daily

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-01-01
• Completion: 2014-02-01
• First posted: 2012-03-29
• Last updated: 2016-04-11
• Results posted: 2016-04-11

Locations

44 sites across 2 countries: United States, Puerto Rico