A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

Trial Profile

A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-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) ; Atazanavir/ritonavir; Cobicistat; Darunavir/ritonavir; Emtricitabine/tenofovir disoproxil fumarate; Lopinavir/ritonavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERALD
  • Sponsors Janssen R&D Ireland; Janssen Research & Development
  • Most Recent Events

    • 06 Oct 2017 Primary endpoint has been met. (Percentage of Participants With Virologic Rebound, (Confirmed), Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level 50 Copies/mL through Week 48), according to a Janssen Pharmaceutica media release.
    • 06 Oct 2017 According to a Janssen Pharmaceutica media release, results from this trial published online in The Lancet HIV 2017.
    • 06 Oct 2017 Results published in the Janssen Pharmaceutica Media 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