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

NCT ID: NCT00023387

Last Updated: 2005-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2001-05-31

Brief Summary

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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

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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.

Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rifapentine

Intervention Type DRUG

25-desacetyl Rifapentine

Intervention Type DRUG

Isoniazid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Marc Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

Audie L. Murphy VA Medical Center, San Antonio TX

Locations

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Central Arkansas Veterans Health System

Little Rock, Arkansas, United States

Site Status

LA County/USC Medical Center

Los Angeles, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Denver Department of Public Health and Hospitals

Denver, Colorado, United States

Site Status

Washington, D.C. VAMC

Washington D.C., District of Columbia, United States

Site Status

Chicago VA Medical Center (Lakeside)

Chicago, Illinois, United States

Site Status

Hines VA Medical Center

Hines, Illinois, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

New Jersey Medical School

Newark, New Jersey, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

Columbia University/Presbyterian Medical Center

New York, New York, United States

Site Status

Harlem Hospital Center

New York, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Nashville VA Medical Center

Nashville, Tennessee, United States

Site Status

University of North Texas Health Science Center

Fort Worth, Texas, United States

Site Status

Thomas Street Clinic

Houston, Texas, United States

Site Status

Audi L. Murphy VA Hospital

San Antonio, Texas, United States

Site Status

Seattle King County Health Department

Seattle, Washington, United States

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Montreal Chest Institute McGill University

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12.

Reference Type BACKGROUND
PMID: 14962821 (View on PubMed)

Related Links

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http://www.cdc.gov/nchstp/tb/tbtc/

(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Other Identifiers

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TBTC Study 25PK

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-2558

Identifier Type: -

Identifier Source: org_study_id