drugset / Trial / NCT07124559
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Phase 1/2
Not yet recruiting
144 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.
Timeline
- Start
- 2026-07-15
- Primary completion
- 2028-01-31
- Completion
- 2028-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifapentine | Small molecule | — | Oral |
| Background | Dolutegravir | Other / unclassified | — | Oral |
| Background | Isoniazid | Small molecule | — | Oral |