Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.

Key Inclusion Criteria:

• Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
• Weight ≥ 35 kg (77 lbs.)
• Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months
• CD4+ cell count > 100 cells/μL
• No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
• Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
• No evidence of current hepatitis B virus (HBV) infection
• No evidence of current hepatitis C virus (HCV) infection

Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Key Exclusion Criteria:

• A new AIDS-defining condition diagnosed within the 30 days prior to Screening
• Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
• Pregnant or lactating subjects

Note: Other protocol defined Inclusion/Exclusion criteria may apply.