Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 865 participants.
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
Interventions
- DRUG rifampin
- DRUG rifapentine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 865 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00694629
The ClinicalTrials.gov registry entry for NCT00694629 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 865 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which rifampin is the first listed.
NCT00694629 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.