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: 14 Dec 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

    • 25 Oct 2017 According to a Janssen Pharmaceutica media release, primary endpoint has been met. (Percentage of Participants With Human Immunodeficiency Virus (HIV) -1 Ribonucleic Acid (RNA) Less Than () 50 Copies per Milliliter (copies/mL) defined by FDA Snapshot Approach)
    • 25 Oct 2017 Results published in a Janssen media release.
    • 25 Oct 2017 Results published in a Janssen PharmaceuticaMedia Release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top