A phase III, two-part study to evaluate the efficacy of Tenofovir Alafenamide versus placebo added to a failing regimen followed by treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 positive, antiretroviral treatment-experienced adults

Project no.: HIV-NAT 200/GS-US-292-0117

This study is divided into 2 parts.

Part 1 is a randomized, double-blind comparison of the addition of tenofovir alafenamide (TAF) or placebo to the antiviral (ARV) regimens of HIV-positive adults who are failing their current ARV regimen.

In Part 2, after a 14-day washout period all participants will receive open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen (E/C/F/TAF STR) and be followed for at least 48 weeks.