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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023426
First received: September 6, 2001
Last updated: September 9, 2005
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Tuberculosis
Drug: rifapentine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Proportion of patients who fail to complete therapy in each of the dosing groups

Secondary Outcome Measures:
  • 1. Rate of serious adverse events in each of the dosing groups
  • 2. Rate of total adverse events in each of the groups
  • 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

Estimated Enrollment: 150
Study Start Date: July 1999
Estimated Study Completion Date: February 2003
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023426

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00023426     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2404, HCK45, 25
Study First Received: September 6, 2001
Last Updated: September 9, 2005
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
tuberculosis
tb
rifapentine
safety
dose

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifapentine
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Leprostatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014