Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

This study is to confirm the dose of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment naive adolescents and evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of E/C/F/TAF STR in HIV-1 infected, ARV treatment naive adolescents and virologically suppressed HIV-1 infected children. Antiviral activity will be determined by the achievement of HIV-1 RNA < 50 copies/mL at Weeks 24 and 48.


Study Type: Interventional
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Enrollment: 73
Study Start Date: May 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Cohort 1 (12 to < 18 years of age)
- Experimental: Cohort 2 (6 to < 12 years of age)