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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 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.
Official Title Multicenter, National, Prospective, Open Label, Randomized, Pilot, Proof-of-concept Study on the Use of Rilpivirine Plus Darunavir/Cobicistat as Substitutive Agents in Virologic Suppressed Patients
Phase Phase IV
ClinicalTrials.gov NCT04064632
Treatments
Darunavir-Cobicistat
Darunavir-Cobicistat
Tradename:PrezcobixOther Names:DRV-COBIClass:Protease Inhibitors (PI)Funding
IndustryJanssen Pharmaceuticals
References
- Maggiolo F, Gianotti N, Comi L, et al. Rilpivirine plus cobicistat-boosted darunavir as alternative to standard three-drug therapy in HIV-infected, virologically suppressed subjects: Final results of the PROBE 2 trial. Antivir Ther. 2021;26:51-7.
Darunavir-Cobicistat Slide Deck
September 12, 2023
Clinical Trial Image Decks
Study 130 - September 12, 2023
PROBE-2 - September 12, 2023