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.

Condition	Treatment or Intervention	Phase
Pulmonary Tuberculosis	Drug: Rifapentine  Drug: Isoniazid	Phase III

Further Study Details: 

Expected Total Enrollment:  1000

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Culture-positive, drug-susceptible pulmonary tuberculosis

Arkansas
      Central Arkansas Veterans Health System, Little Rock,  Arkansas,  72205,  United States
California
      LA County/USC Medical Center, Los Angeles,  California,  90033,  United States
      University of California, San Francisco, San Francisco,  California,  94110,  United States
Colorado
      Denver Department of Public Health and Hospitals, Denver,  Colorado,  80204,  United States
District of Columbia
      Washington, D.C. VAMC, Washington,  District of Columbia,  20422,  United States
Illinois
      Hines VA Medical Center, Hines,  Illinois,  60141,  United States
      Chicago VA Medical Center (Lakeside), Chicago,  Illinois,  60611,  United States
Maryland
      Johns Hopkins University School of Medicine, Baltimore,  Maryland,  21287-0003,  United States
Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
New Jersey
      New Jersey Medical School, Newark,  New Jersey,  07107-3001,  United States
New York
      New York University School of Medicine, New York,  New York,  10016,  United States
      Columbia University/Presbyterian Medical Center, New York,  New York,  10032,  United States
      Harlem Hospital Center, New York,  New York,  10037,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  34222,  United States
      Carolinas Medical Center, Charlotte,  North Carolina,  28203,  United States
Tennessee
      Nashville VA Medical Center, Nashville,  Tennessee,  37212-2637,  United States
Texas
      University of North Texas Health Science Center, Fort Worth,  Texas,  76107-2699,  United States
      Thomas Street Clinic, Houston,  Texas,  77009,  United States
      Audi L. Murphy VA Hospital, San Antonio,  Texas,  78284,  United States
Washington
      Seattle King County Health Department, Seattle,  Washington,  98104,  United States
Canada, British Columbia
      University of British Columbia, Vancouver,  British Columbia,  Canada V5Z 4R4,  Canada
Canada, Manitoba
      University of Manitoba, Winnipeg,  Manitoba,  CANADA R3A 1R8,  Canada
Canada, Quebec
      Montreal Chest Institute McGill University, Montreal,  Quebec,  H2X 2P4Pq Canada,  Canada

Study ID Numbers:  1427; TBTC Study 22
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  September 6, 2001
ClinicalTrials.gov Identifier:  NCT00023335
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08