1269 - Phase 2/3 open label study of F/TAF in HIV-1 infected children
Research type
Research Study
Full title
A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen
IRAS ID
180815
Contact name
Caroline Foster
Contact email
Sponsor organisation
Gilead Sciences International Ltd
Eudract number
2015-001339-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 15 days
Research summary
This is an open label, multi-cohort study to evaluate switching to emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents already on treatment.\n\nParticipants will be HIV-1 infected adolescents and children ages 12 to <18 (cohort 1) and 6 to <12 (cohort 2) who are virologically suppressed (HIV-1 levels < 50 copies/mL for at least 6 consecutive months) and on a stable 2-NRTI-containing regimen. Subjects will continue their 3rd antiretroviral medication.\n\nThe study drugs to be investigated are F/TAF. The study will evaluate the drug levels of TAF and confirm the optimal TAF dose in HIV-1 infected children and adolescents, and evaluate the safety and tolerability of F/TAF.\n\nCohort 1 will recruit approximately 25 adolescents to receive F/TAF. Recruitment will be limited to cohort 1 until the drug is deemed safe and acceptable and the TAF dose confirmed for adolescents. Cohort 2 will recruit approximately 75 children to be randomised in a 2:1 ratio to F/TAF vs emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in 2 parts. Part A: approximately 30 children will be recruited to confirm the TAF dose, followed by part B: a further 45 children recruited. The UK will only recruit into cohort 2.\n\nA minimum of 100 subjects ages 6 to < 18 years of age will be enrolled at approximately 10 global centres, including one UK centre. \n\nParticipants will receive their allocated treatment for 96 weeks and will attend 14 scheduled clinic visits, from screening to week 96, after which they will attend a 30 day follow-up visit. Procedures include physical examinations, ECGs, blood samples, urine samples and dual x-ray absorptiometry (DXA) scans to assess bone density. Cohort 1 and cohort 2 (part A) will participate in intensive evaluation of TAF blood levels.\n\nThe Sponsor is Gilead Sciences, Inc.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1676
Date of REC Opinion
20 Jan 2016
REC opinion
Further Information Favourable Opinion