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.