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: 12 Oct 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

    • 09 Oct 2017 Planned End Date changed from 30 Nov 2020 to 5 Apr 2020.
    • 25 Sep 2017 According to a Janssen Research and Development media release, 48-week data from this trial will be presented at the 2017 European AIDS Conference.
    • 25 Sep 2017 According to a company media release, Janssen Research & Development has submitted of an NDA to the US FDA for darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF), a complete, once daily regimen being investigated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients aged 12 years and older. The filing was based on results from EMERALD and AMBER studies.
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