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Official Title A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Cobicistat (GS-9350)-boosted Atazanavir (ATV/Cobicistat [GS-9350]) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase II
ClinicalTrials.gov NCT00892437
Treatments
Atazanavir-Cobicistat
, Atazanavir-Cobicistat
Tradename:EvotazOther Names:ATV-COBIClass:Protease Inhibitors (PI)Cobicistat
Cobicistat
Tradename:TybostOther Names:COBIClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryGilead Sciences
References
- Elion R, Cohen C, Gathe J, et al. Phase 2 study of cobicistat versus ritonavir each with once-daily atazanavir and fixed-dose emtricitabine/tenofovir df in the initial treatment of HIV infection. AIDS. 2011;25:1881-6.
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Cobicistat (GS-9350)-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase III
ClinicalTrials.gov NCT01108510
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Atazanavir-Cobicistat
, Atazanavir-Cobicistat
Tradename:EvotazOther Names:ATV-COBIClass:Protease Inhibitors (PI)Cobicistat
Cobicistat
Tradename:TybostOther Names:COBIClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryGilead Sciences
References
- Gallant JE, Koenig E, Andrade-Villanueva J, et al. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013;208:32-9.
- Gallant JE, Koenig E, Andrade-Villanueva JF, et al. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015;69:338-40.
Official Title A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
Phase Phase III
ClinicalTrials.gov NCT01363011
Treatments
Atazanavir-Cobicistat
Atazanavir-Cobicistat
Tradename:EvotazOther Names:ATV-COBIClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- McDonald CK, Martorell C, Ramgopal M, et al. Cobicistat-boosted protease inhibitors in HIV-infected patients with mild to moderate renal impairment. HIV Clin Trials. 2014;15:269-73.
Atazanavir-Cobicistat Slide Deck
September 19, 2023
Clinical Trial Image Decks
Study 105 - September 19, 2023
Study 114 - September 19, 2023
Study 118 - September 19, 2023