Tuberculosis Clinical Trials Consortium Study 35
Phase 1/2
Completed
NCT03730181
| Condition | Latent Tuberculosis |
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| Phase | Phase 1/2 |
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| Sponsor | Centers for Disease Control and Prevention |
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| Status | Completed |
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| Enrollment | 69 participants |
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| Interventions | Rifapentine, Isoniazid |
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| Start date | Nov 12, 2019 |
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| Completion date | Dec 15, 2024 |
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| Results posted | Jul 24, 2026 |
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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.
Rifapentine Pharmacokinetic Exposure (AUC) Following Weekly 3HP Administration
During the 12-week treatment period, based on pharmacokinetic samples collected during study treatment · mg·h/L
| 3HP (Rifapentine Plus Isoniazid) | 609 mg·h/L |
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| 3HP (Rifapentine Plus Isoniazid) | 421 mg·h/L |
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| 3HP (Rifapentine Plus Isoniazid) | 392 mg·h/L |
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| 3HP (Rifapentine Plus Isoniazid) | 394 mg·h/L |
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Open in BENITIONS
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