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A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/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.

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Trial Profile

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/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.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Cobicistat; Darunavir; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 16 Nov 2017 Results summarizing the development (or identification) of post-baseline resistance (RAMs and antiretroviral phenotypic susceptibility) among subjects receiving darunavir QD dosing published in the HIV Clinical Trials
    • 16 Feb 2017 Results (n=2329) of seven phase 2 and 3 studies (ARTEMIS, GS-US-299-0102, ODIN, MONET,PROTEA, GS-US-216-0130,INROADS ) presented at the 24th Conference on Retroviruses and Opportunistic Infections.
    • 25 Mar 2014 Planned number of patients changed from 150 to 155 as reported by ClinicalTrials.gov record.

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