GS-US-380-1489
A Phase 3, Randomised, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Project Summary
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), compared to a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naïve-adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.
The study is double-blind and designed as non-inferiority trial.
Key Project Information
Dates: June 2016 - (ongoing)
UCL lead/Principal Investigator: Dr Laura Waters
Lead organisation: Gilead Sciences
Partners: Central and North West London NHS Foundation Trust
Location: Global
Funding: Gilead Sciences
Contact: mmc-research-cnwl@nhs.net
Jonathan Alldis
Dr Alejandro Arenas-Pinto
Dr Lewis Haddow
Dr Sarah Pett
Nicola Stewart
Publications
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Lancet. 2017