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Clinical Trial Summary

The primary objective of this study is to confirm the TAF dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of F/TAF in HIV-1 infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 ribonucleic acid [RNA] for a period of at least 6 months) while on a stable NRTI containing regimen.


Clinical Trial Description

Cohorts 2, 3, and 4 will be on a boosted protease inhibitor (PI) or any other 3rd antiretroviral (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-atazanavir (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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02285114
Study type Interventional
Source Gilead Sciences
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 20, 2015
Completion date December 2024

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