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Common TitleGS-299-0102 Industry
Official Title A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (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
Phase Phase II
ClinicalTrials.gov NCT01565850
Treatments
Darunavir-Cobicistat
, Darunavir-Cobicistat
Tradename:PrezcobixOther Names:DRV-COBIClass:Protease Inhibitors (PI)Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:SymtuzaOther Names:DRV-COBI-TAF-FTCClass:Single-Tablet RegimensCategories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryGilead Sciences
References
- Mills A, Crofoot G Jr, McDonald C, et al. Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study. J Acquir Immune Defic Syndr. 2015;69:439-45.
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)Darunavir-Cobicistat
Darunavir-Cobicistat
Tradename:PrezcobixOther Names:DRV-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.
Official Title A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV-1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With No Darunavir Resistance-associated Mutations
Phase Phase IIIB
ClinicalTrials.gov NCT01440569
Treatments
Darunavir-Cobicistat
Darunavir-Cobicistat
Tradename:PrezcobixOther Names:DRV-COBIClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-NaiveTreatment-ExperiencedGeneral Pharmacology
Funding
IndustryGilead Sciences and Janssen Pharmaceuticals
References
- Tashima K, Crofoot G, Tomaka FL, et al. Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial. AIDS Res Ther. 2014;11:39.