This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single
tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.
Safety, tolerability, and efficacy will also be evaluated through Week 48.
A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive
EVG/COBI/FTC/TDF as follows:
- Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK,
and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and
at least 4 participants 15 to < 18 years of age.
- Part B: Following confirmation of EVG exposure in at least 12 participants from Part A,
34 to 38 participants in addition to those enrolled in Part A will be enrolled to
evaluate the safety, tolerability and antiviral activity of EVG/COBI/FTC/TDF STR.