IMPAACT 2024
Study Status
DAIDS Number
Primary Protocol Team Members
Summary
IMPAACT 2024 is a Phase I/II, multi-site, open-label, non-comparative dose finding study of a once-daily, 28-day regimen of isoniazid and rifapentine (RPT; 1HP) for the prevention of tuberculosis in children. The study is designed to determine the weight-band dosing of RPT as part of the 1HP regimen and will evaluate the pharmacokinetic, safety, and tolerability of RPT as part of the 1HP regimen. Children living with and without HIV who are two to less than 13 years of age at risk for TB will be enrolled and followed for 24 weeks. Children with HIV must be taking an ARV regimen of dolutegravir and two NRTIs. The study will also evaluate the effect of RPT on dolutegravir pharmacokinetics.
Site selection was completed in August 2022 and was open to all IMPAACT sites. Planned sites are located in Botswana, Haiti, Kenya, South Africa, Thailand, Uganda, and Zimbabwe.