Approval Probability
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Adjusted LOA
ML Risk
rifapentine · 3 trials · 3 indications
Target AUC is no more than 25% lower than, and no more than 75% higher than, the target AUC of 522 mcg\*h/L. Data to be used for dose adjustments throughout the study and to create dosing algorithm for pediatric subgroups.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | rifampin, isoniazid, pyrazinamide, ethambutol |
| 2 | EXPERIMENTAL | rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol |
| 3 | EXPERIMENTAL | rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol |
| 4 | EXPERIMENTAL | rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol |
| Single Arm Rifapentine and Isoniazid | EXPERIMENTAL | Single arm, open label and exposure-controlled. Intervention is rifapentine given in a new fixed dose combination once-weekly, in combination with isoniazid for 12 weeks, in HIV-infected and HIV-uninfected children aged 0-12 years in whom LTBI treatment is indicated. The protocol allows for parallel enrolment of children into cohorts 1 and 2, simultaneously, using a predetermined modeled initial dose for each cohort, separately. Similarly, cohorts 3 and 4 will be enrolled in parallel, using modeled doses for each cohort, based on data from cohorts 1 and 2 and historical data from TBTC trials. |
| cohort 1 | EXPERIMENTAL | Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1). |
| cohort 2 | EXPERIMENTAL | Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2). |
| cohort 3 (optional) | EXPERIMENTAL | Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3). |
| Name | Type | Description |
|---|---|---|
| rifampin | DRUG | tablet, 10 mg/kg, daily, 8 weeks |
| rifapentine | DRUG | tablet, 10 mg/kg, daily, 8 weeks |
| Isoniazid | DRUG | Isoniazid. 25mg/kg |
| rifapentine (M000473) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| EFZ EMT TDF | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion Criteria: 1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. 2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment. 3...
Rifapentine is a small molecule antibiotic used for Tuberculosis, including latent tuberculosis, pulmonary tuberculosis, and tuberculosis. It is being developed by Sanofi for the treatment of these infectious disease indications.
Rifapentine targets the bacterial RNA polymerase, inhibiting mycobacterial protein synthesis. It is used against Mycobacterium tuberculosis, the bacterium that causes tuberculosis.
Rifapentine is developed by Sanofi, a global pharmaceutical company. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in treating tuberculosis.
Rifapentine is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Clinical trials are ongoing to assess its use in tuberculosis.
Rifapentine has been studied in clinical trials including NCT00694629, a Phase 2 study in pulmonary tuberculosis, and NCT01690403 and NCT03730181, both Phase 1 studies in tuberculosis and latent tuberculosis, respectively.
Rifapentine is also known by the brand name Priftin. It is an antibiotic used to treat tuberculosis, and Priftin is the marketed name for the same drug.