GS-US-292-0117 A Phase 3, 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
Question: To evaluate the efficacy of tenofovir alafenamide (TAF) versusplacebo, each administered with the existing, failing antiretroviral regimen, as demonstrated by the proportion of subjects with HIV-1 RNA decreases from baseline exceeding 0.5 log10 after 10 days of therapy in HIV-1 positive, antiretroviral treatment experienced adult subjects. To evaluate the efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single tablet regimen (E/C/F/TAF STR) after 24 and 48 weeks.
POP: ARV-experienced, with plasma HIV-1 RNA levels ≥ 500 copies/mLbut ≤100,000 copies/mL with documented primary resistance mutations to NRTIs as well as M184V and having at least one primary resistance mutation to NNRTIs and/or protease inhibitors (PIs).
MED: Part 1: Tenofovir alafenamide Part 2: Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg