Tuberculosis Clinical Trials Consortium Study 35
Фаза 1/2
Завершено
NCT03730181
| Заболевание | Latent Tuberculosis |
|---|
| Фаза | Фаза 1/2 |
|---|
| Спонсор | Centers for Disease Control and Prevention |
|---|
| Статус | Завершено |
|---|
| Участники | 69 участн. |
|---|
| Вмешательство | Rifapentine, Isoniazid |
|---|
| Дата начала | 12.11.2019 |
|---|
| Дата завершения | 15.12.2024 |
|---|
| Публикация результатов | 24.07.2026 |
|---|
Кратко
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 |
|---|
| 3HP (Rifapentine Plus Isoniazid) | 421 mg·h/L |
|---|
| 3HP (Rifapentine Plus Isoniazid) | 392 mg·h/L |
|---|
| 3HP (Rifapentine Plus Isoniazid) | 394 mg·h/L |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.