Last updated on August 2019

Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen


Brief description of study

This study will evaluate the pharmacokinetics (PK), safety, and efficacy of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 RNA for a period of at least 6 months) while on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen.

Detailed Study Description

Cohorts 2, 3, and 4 will be on a boosted protease inhibitor (PI) or any other 3rd ARV agent and will switch their current 2-NRTI-containing regimen to open-label F/TAF while continuing their boosted PI or 3rd agent through 48 weeks. A minimum of 10 participants each in Groups 1 and 2 of Cohort 2, and Cohorts 3 and 4, who are on boosted-ATV as their 3rd ARV agent will be enrolled. Participants in Cohort 2, Group 1 receive boosted PI agents only. Cohorts 2, 3, and 4 will be enrolled by cohort into a two-part study (Parts A and B).

After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) The participant turns 18 years old and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or b), F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or c), Gilead Sciences elects to terminate development of F/TAF in the applicable country.

Clinical Study Identifier: NCT02285114

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Rahima Moosa Mother and Child Hopsital

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