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 I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Rifapentine	Dispersible Tablet administered orally
DRUG	Isoniazid	Dispersible Tablet administered orally
DRUG	Dolutegravir	Tablets and Tablets for oral suspension administered orally

Timeline

• Start date: 2026-05-15
• Primary completion: 2028-01-31
• Completion: 2028-05-31
• First posted: 2025-08-15
• Last updated: 2026-02-03

Locations

11 sites across 6 countries: Botswana, Haiti, Kenya, Thailand, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study