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NCT00023387 Clinical Trial

TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

Tuberculosis Clinical Trial

Official title:
Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00023387
Other study ID # CDC-NCHSTP-2558
Secondary ID TBTC Study 25PK
Status Completed
Phase N/A
First received September 6, 2001
Last updated September 9, 2005
Start date March 2000
Est. completion date May 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: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 36
Est. completion date May 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion:

Patients enrolled in TBTC Study 25 Informed consent

Exclusion:

Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rifapentine

• 25-desacetyl 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 (1)

Weiner M, Bock N, Peloquin CA, Burman WJ, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S; Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1191-7. Epub 2004 Feb 12. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
Secondary 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.
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