drugset / Trial / NCT01565850

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

NCT01565850

Phase 2 Completed 153 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-04
Primary completion
2013-01
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cobicistat Small molecule 150 mg Oral
Subject D/C/F/TAF Unknown Oral
Comparator Darunavir Small molecule 800 mg Oral
Subject FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily Unknown Oral

Indications