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

September 9, 2005 updated by: Centers for Disease Control and Prevention

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

US Department of Veterans Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion

May 1, 2001

Study Registration Dates

First Submitted

September 6, 2001

First Submitted That Met QC Criteria

September 8, 2001

First Posted (ESTIMATE)

September 10, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2005

Last Update Submitted That Met QC Criteria

September 9, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-2558
  • TBTC Study 25PK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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