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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention Department of Veterans Affairs |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00023426 |
Purpose
Randomized, double-blind study of the tolerability of three different doses of rifapentine
| Condition | Intervention | Phase |
|
Tuberculosis |
Drug: rifapentine |
Phase II |
| MedlinePlus related topics: | Tuberculosis |
| Drug Information available for: | Rifapentine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study |
| Official Title: | TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine |
| Estimated Enrollment: | 150 |
| Study Start Date: | July 1999 |
| Estimated Study Completion Date: | February 2003 |
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusions:
Exclusions:
Contacts and Locations![]() |
Show 23 Study Locations |
| Principal Investigator: | Naomi Bock, MD | Centers for Disease Control & Prevention |
More Information
(Click here for more information about the Tuberculosis Trials Consortium(TBTC) 
  |
| Study ID Numbers: | CDC-NCHSTP-2404, HCK45, 25 |
| First Received: | September 6, 2001 |
| Last Updated: | September 9, 2005 |
| ClinicalTrials.gov Identifier: | NCT00023426 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
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