drugset / Trial / NCT03730181
Tuberculosis Clinical Trials Consortium Study 35
Phase 1/2
Completed
62 enrolled
Centers for Disease Control and Prevention
Chris Hani Baragwanath Academic Hospital · collabJohns Hopkins University · collabSanofi · collabUniversity of Cape Town · collabUniversity of Stellenbosch · collabWashington D.C. Veterans Affairs Medical Center · collab
NaSingle-groupOpen-labelPrevention
Summary
Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to Mycobacterium tuberculosis (M. tuberculosis) will require higher mg/kg rifapentine dosing than adults to achieve adult- exposures which are correlated with efficacy in trials of TB prevention. Investigators further hypothesize that rifapentine will be safe and well-tolerated in HIV-infected and uninfected children who require treatment for LTBI.
Timeline
- Start
- 2019-10-12
- Primary completion
- 2024-12-15
- Completion
- 2025-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isoniazid | Small molecule | 25 mg/kg | — |
| Subject | Rifapentine | Small molecule | 25 mg/kg | — |