IMPAACT 2024: Phase I/II Dose Finding and Safety Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Infants, Children and Adolescents

Study Status Study Restriction

In Development

US & Non-US

What is IMPAACT 2024?

IMPAACT 2024 is a Phase I/II, multi-site, open-label, dose finding and safety study of children less than 15 years of age who qualify for TB preventive therapy. The study is designed to determine the weight-banded dosing, safety and tolerability of rifapentine (RPT) as part of the once-daily, 28-day regimen of isoniazid (INH) and RPT (1HP). Children will be enrolled in age cohorts and both children living with and not living with HIV will be included in each age cohort. Children living with HIV must be receiving dolutegravir (DTG) or efavirenz (EFV) as part of their antiretroviral treatment regimen.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Co-Chair: Christy Beneri

Study Co-Chair: Nichole Salazar-Austin

DAIDS Medical Officer: Renee Browning

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Shane Reynolds

Clinical Trials Specialist: Anne Rinaldi

Data Manager: Mattie Bartlett

Data Manager: Amanda Golner

Investigator: Yael Hirsh-Moverman

Investigator: Helena Rabie

Investigator: Vanessa Rouzier

Investigator: Ethel Weld

Laboratory Specialist: Ceora Beijer

Laboratory Specialist: William Murtaugh

Pharmacologist: Kendra  Radtke

SC Representative: Anneke Hesseling

Statistician: Paula Britto

Statistician: Grace Montepiedra

Pharmacometrician: Rada Savic

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.