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

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00023387
Collaborator
US Department of Veterans Affairs (U.S. Fed)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults
Study Start Date :
Mar 1, 2000
Study Completion Date :
May 1, 2001

Outcome Measures

Primary Outcome Measures

  1. Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg []

Secondary Outcome Measures

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Centers for Disease Control and Prevention
  • US Department of Veterans Affairs

Investigators

  • Principal Investigator: Marc Weiner, MD, Audie L. Murphy VA Medical Center, San Antonio TX

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00023387
Other Study ID Numbers:
  • CDC-NCHSTP-2558
  • TBTC Study 25PK
First Posted:
Sep 10, 2001
Last Update Posted:
Sep 13, 2005
Last Verified:
Sep 1, 2005
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2005