A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

Trial Profile

A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2017

At a glance

  • Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Cobicistat/darunavir; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms AMBER
  • Sponsors Janssen Sciences Ireland UC
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 24 Mar 2017 Planned primary completion date changed from 1 Apr 2017 to 14 Jul 2017.
    • 27 Jan 2017 Planned End Date changed from 1 Apr 2020 to 1 Nov 2020.
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