HIV Infections Clinical Trial
Official title:
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents
The primary objectives of this study are 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) (Part A) and to evaluate the safety
and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected,
antiretroviral (ARV) treatment-naive adolescents.
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.
n/a
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