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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
Purpose / DescriptionHAART is generally based on the combination of three active drugs. Two of them, usually defined the backbone, belong to the nucleosidic analogues class (NRTI). In the last years, drugs of this class have been associated to several long-term adverse events of HAART such as lipoatrophy, cardiovascular diseases, bone and kidney toxicity. Furthermore the need of a triple drug regimen has recently been questioned as maintenance therapy in well controlled chronically treated subjects. In this setting, less drug regimens (LDR) have been proposed. LDR would allow a reduced exposure to drugs and eventually limit drug-drug interactions, drug-related toxicities and would allow treatment simplification so to enhance HAART acceptability, tolerability and persistence.
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 13, 2023
Clinical Trial Image Decks
Study 130 - September 13, 2023
PROBE-2 - September 13, 2023