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

Website: https://clinicaltrials.gov/ct2/show/NCT02607930

Research Team

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