Common TitleStudy 104/111
Official Title 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
Phase Phase III
ClinicalTrials.gov NCT01797445
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
, Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Tradename:StribildOther Names:EVG-COBI-TDF-FTCClass:Single-Tablet RegimensElvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Resistance/Virological FailureTreatment-Naive
Funding
IndustryGilead Sciences
References
- Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016;17:78-87.
- Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385:2606-15.