TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
- Conditions
- Tuberculosis
- Registration Number
- NCT00023387
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.
Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
- Detailed Description
We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
- Secondary Outcome Measures
Name Time Method Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
Trial Locations
- Locations (23)
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
Chicago VA Medical Center (Lakeside)
🇺🇸Chicago, Illinois, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Audi L. Murphy VA Hospital
🇺🇸San Antonio, Texas, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Montreal Chest Institute McGill University
🇨🇦Montreal, Quebec, Canada
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Seattle King County Health Department
🇺🇸Seattle, Washington, United States
Harlem Hospital Center
🇺🇸New York, New York, United States
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States
Nashville VA Medical Center
🇺🇸Nashville, Tennessee, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
New Jersey Medical School
🇺🇸Newark, New Jersey, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Columbia University/Presbyterian Medical Center
🇺🇸New York, New York, United States
Hines VA Medical Center
🇺🇸Hines, Illinois, United States
Denver Department of Public Health and Hospitals
🇺🇸Denver, Colorado, United States
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, United States
Washington, D.C. VAMC
🇺🇸Washington, District of Columbia, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Boston Medical Center
🇺🇸Boston, Massachusetts, United States