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NCT00694629 · ClinicalTrials.gov registry record · Phase 2
TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
A Phase 2 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 2
- Development phase
- 865
- Enrollment target
NCT00694629: Completed Phase 2 study, sponsored by Centers for Disease Control and Prevention.
NCT00694629 is a Phase 2 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 865 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (550% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00694629, a Phase 2 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 865 participants
- Enrollment target
Study Summary
Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective * To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). Secondary Objectives * To determine and compare for each regimen the time to culture-conversion, using data from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses). * To determine and compare for each regimen the proportion of patients with any Grade 3 or 4 adverse reactions * To determine the correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure * To store serum for future assessment of biomarkers of TB treatment response and hypersensitivity to study drugs. * To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients * To determine the tolerability and safety, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an extension to the main study after enrollment in the main study has been completed. Design This will be a prospective, multicenter, open-label clinical study. Adults suspected of having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive either the experimental intensive phase tuberculosis treatment regimen or the standard intensive phase tuberculosis treatmen
Primary Outcome
Proportion of participants with negative Mycobacterium tuberculosis sputum cultures at completion of the 8-week intensive phase of treatment.
Interventions
- DRUG rifampin
- DRUG rifapentine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 865 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00694629 record still lists
NCT00694629 is an interventional study that assigns participants to a tested intervention. The registered 865 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (550% higher).
The record links to 0 conditions, and to 2 interventions - of which rifampin is the first listed.
NCT00694629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00694629 about?
NCT00694629 is a clinical study titled "TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment". Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective * To compare the antimic...
What is the current status of trial NCT00694629?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 865 participants. The study started on 2008-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00694629?
The interventions under investigation include: rifampin (DRUG), rifapentine (DRUG).
Who is sponsoring clinical trial NCT00694629?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00694629's enrollment target sits among peer trials
865 33rd of 2000 higher than 1,968 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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