A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 10 Aug 2017
At a glance
- Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Atazanavir; Atazanavir/cobicistat; Cobicistat; Cobicistat/darunavir; Darunavir; Emtricitabine/tenofovir disoproxil fumarate; Lamivudine/abacavir; Ritonavir
- Indications HIV-1 infections
- Focus Pharmacodynamics; Registrational
- Sponsors Gilead Sciences
- 10 Aug 2017 According to a Gilead Sciences media release, the US FDA has granted priority review for the company's NDA for BIC/FTC/TAF, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
- 13 Jul 2017 The company's MAA for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency (EMA), according to a Gilead Sciences media release. The MAA was supported by data from this and 3 other phase III trials.
- 12 Jun 2017 According to a Gilead Sciences media release, the company plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History