TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Tuberculosis Clinical Trial

Official title:

TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023426
• Other study ID #: CDC-NCHSTP-2404
• Secondary ID: HCK4525
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2001
• Last updated: September 9, 2005
• Start date: July 1999
• Est. completion date: February 2003

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized, double-blind study of the tolerability of three different doses of rifapentine

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusions:

1. Drug susceptible culture-positive tuberculosis

2. Adequate induction therapy

3. Age >18

4. Normal screening labs

5. Karnofsky >=60

6. Informed consent

7. Birth control if of child bearing potential

Exclusions:

1. SilicoTB

2. Skeletal or CNS TB

3. Pregnant or breastfeeding

4. Intolerance to INH or rifamycins

5. Over 70 days TB treatment just prior to enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• rifapentine

Locations

Country	Name	City	State
Canada	Montreal Chest Institute McGill University	Montreal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Chicago VA Medical Center (Lakeside)	Chicago	Illinois
United States	Denver Department of Public Health and Hospitals	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University of North Texas Health Science Center	Fort Worth	Texas
United States	Hines VA Medical Center	Hines	Illinois
United States	Thomas Street Clinic	Houston	Texas
United States	Central Arkansas Veterans Health System	Little Rock	Arkansas
United States	LA County/USC Medical Center	Los Angeles	California
United States	Nashville VA Medical Center	Nashville	Tennessee
United States	Columbia University/Presbyterian Medical Center	New York	New York
United States	Harlem Hospital Center	New York	New York
United States	New York University School of Medicine	New York	New York
United States	New Jersey Medical School	Newark	New Jersey
United States	Audi L. Murphy VA Hospital	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Seattle King County Health Department	Seattle	Washington
United States	Washington, D.C. VAMC	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Bock NN, Sterling TR, Hamilton CD, Pachucki C, Wang YC, Conwell DS, Mosher A, Samuels M, Vernon A; Tuberculosis Trials Consortium, Centers for Disease Control and Prevention, Atlanta, Georgia. A prospective, randomized, double-blind study of the tolerabil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who fail to complete therapy in each of the dosing groups
Secondary	1. Rate of serious adverse events in each of the dosing groups
Secondary	2. Rate of total adverse events in each of the groups
Secondary	3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

External Links

•   (Click here for more information about the Tuberculosis Trials Consortium(TBTC)