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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2017

At a glance

  • Drugs Cobicistat (Primary) ; Darunavir (Primary) ; Nucleoside reverse transcriptase inhibitors
  • Indications HIV-1 infections
  • Focus Adverse reactions; Registrational
  • 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
    • 10 Jun 2017 Biomarkers information updated
    • 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.
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