Primary Objective:

To evaluate the efficacy of a directly-observed, largely-intermittent, six-month regimen of rifampin, pyrazinamide, ethambutol among patients with culture confirmed isoniazid-resistant M. tuberculosis.

Secondary Objectives:

To describe the rate, severity and timing of toxicities and drug intolerances associated with this treatment regimen.

To describe the utility of this regimen among patients who are unable to continue the standard 4-drug regimen due to the development of intolerance to isoniazid

Condition	Treatment or Intervention
Tuberculosis	Drug: Rifampin  Drug: Pyrazinamide  Drug: Ethambutol

Genders Eligible for Study:  Both

Criteria

• Patients with culture-confirmed isoniazid-resistant M. 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:  2340; 24
Record last reviewed:  February 2001
Last Updated:  October 13, 2004
Record first received:  September 6, 2001
ClinicalTrials.gov Identifier:  NCT00023374
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08