GS-US-380-1490

A Phase 3, Randomised, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide 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 dolutegravir (DTG) with a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naïve adult subjects as determined by the achievement of HIV-1 RNA less than 50 copies/mL at Week 48.

Key Project Information

Dates: June 2016 - (ongoing)

UCL lead/Principal Investigator: Dr Laura Waters

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/NCT02607956

Research Team

Jonathan Alldis

Dr Alejandro Arenas-Pinto

Dr Lewis Haddow 

Dr Sarah Pett

Nicola Stewart

Puclications

Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Lancet. 2017.