Common TitleStudy 102
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/Cobicistat (GS-9350) Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase III
ClinicalTrials.gov NCT01095796
Treatments
Efavirenz-Tenofovir DF-Emtricitabine
, Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensElvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Tradename:StribildOther Names:EVG-COBI-TDF-FTCClass:Single-Tablet RegimensCategories Treatment-NaiveResistance/Virological Failure
Funding
IndustryGilead Sciences
References
- Sax PE, DeJesus E, Mills A, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012;379:2439-48.
- White KL, Kulkarni R, McColl DJ, et al. Week 144 resistance analysis of elvitegravir/cobicistat/emtricitabine/tenofovir DF versus efavirenz/emtricitabine/tenofovir DF in antiretroviral-naive patients. Antivir Ther. 2015;20:317-27.
- Zolopa A, Sax PE, DeJesus E, et al. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013;63:96-100.