Conditions: HIV
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks.

After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country.

Interventions: intervention 1: E/C/F/TAF
Intervention descriptions: intervention 1: 150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Protocol document: