Tuberculosis Clinical Trials Consortium Study 35
1/2期
已完成
NCT03730181
| 适应症 | Latent Tuberculosis |
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| 分期 | 1/2期 |
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| 申办方 | Centers for Disease Control and Prevention |
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| 状态 | 已完成 |
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| 受试者人数 | 69 人 |
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| 干预（药物） | Rifapentine, Isoniazid |
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| 开始日期 | 2019年11月12日 |
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| 完成日期 | 2024年12月15日 |
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| 结果公布日 | 2026年7月24日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。