Currently submitted to: JMIR Research Protocols
Date Submitted: Jun 1, 2026
Open Peer Review Period: Jun 4, 2026 - Jun 29, 2026
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Dosing and Safety of Once-Weekly Rifapentine and Isoniazid for 12 Weeks for Tuberculosis Preventive Therapy in Children With and Without HIV: Phase I/II Open-Label Exposure-Controlled Dose-Finding and Safety Study Protocol for TBTC Study 35
ABSTRACT
Background:
Young children with exposure to or infection with Mycobacterium tuberculosis are at high risk of developing tuberculosis (TB) disease, and postexposure TB preventive treatment (TPT) decreases this risk. Evidence is limited on the dosing and safety of the 12-dose once-weekly rifapentine and isoniazid regimen (3HP) for TPT in children younger than 2 years and in children living with HIV.
Objective:
This protocol describes TBTC Study 35, which aims to establish practical age- and weight-banded rifapentine doses for 3HP in children aged 0 to 12 years, including children younger than 2 years and children living with HIV, while assessing safety, tolerability, palatability, and acceptability.
Methods:
TBTC Study 35 is a phase I/II, open-label, multisite, single-arm, exposure-controlled dose-finding and safety study of 3HP in children aged 0 to 12 years, including children living with HIV. Novel water-dispersible rifapentine and isoniazid formulations are used. Building on TBTC Study 26 data, initial rifapentine doses were selected, and nonlinear mixed-effects modeling will be used to predict and analyze subsequent rifapentine doses. Safety end points will be evaluated throughout the 12-week treatment period and 12-week post-treatment follow-up.
Results:
Recruitment began in November 2019. The last participant was enrolled in December 2023, and follow-up was completed in May 2024. Data analysis is ongoing, and trial results are expected to be disseminated during 2026.
Conclusions:
TBTC Study 35 is expected to provide pharmacokinetic and safety data to inform practical pediatric 3HP dosing recommendations, including for children younger than 2 years and children living with HIV. Clinical Trial: ClinicalTrials.gov NCT03730181
Citation
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