TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

Pulmonary Tuberculosis Clinical Trial

Official title:

TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023335
• Other study ID #: CDC-NCHSTP-1427
• Secondary ID: TBTC Study 22
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2001
• Last updated: September 1, 2005
• Start date: April 1995
• Est. completion date: March 2001

Study information

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

Clinical Trial Summary

Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.

Secondary Objectives:

To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.

To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.

To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.

To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.

To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.

To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.

To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: - Culture-positive, drug-susceptible pulmonary tuberculosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Rifapentine

• Isoniazid

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 (3)

Benator D, Bhattacharya M, Bozeman L, Burman W, Cantazaro A, Chaisson R, Gordin F, Horsburgh CR, Horton J, Khan A, Lahart C, Metchock B, Pachucki C, Stanton L, Vernon A, Villarino ME, Wang YC, Weiner M, Weis S; Tuberculosis Trials Consortium. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial. Lancet. 2002 Aug 17;360(9332):528-34. — View Citation

Vernon A, Burman W, Benator D, Khan A, Bozeman L. Acquired rifamycin monoresistance in patients with HIV-related tuberculosis treated with once-weekly rifapentine and isoniazid. Tuberculosis Trials Consortium. Lancet. 1999 May 29;353(9167):1843-7. — View Citation

Weiner M, Burman W, Vernon A, Benator D, Peloquin CA, Khan A, Weis S, King B, Shah N, Hodge T; Tuberculosis Trials Consortium. Low isoniazid concentrations and outcome of tuberculosis treatment with once-weekly isoniazid and rifapentine. Am J Respir Crit Care Med. 2003 May 15;167(10):1341-7. Epub 2003 Jan 16. — View Citation

External Links

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