TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults
2 other identifiers
interventional
36
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2000
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 6, 2001
CompletedFirst Posted
Study publicly available on registry
September 10, 2001
CompletedSeptember 13, 2005
September 1, 2005
September 6, 2001
September 9, 2005
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
Secondary Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients enrolled in TBTC Study 25 Informed consent
You may not qualify if:
- Severe anemia (Hct \<25%) Any severe adverse event related to study drugs in TBTC Study 25
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205, United States
LA County/USC Medical Center
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94110, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204, United States
Washington, D.C. VAMC
Washington D.C., District of Columbia, 20422, United States
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611, United States
Hines VA Medical Center
Hines, Illinois, 60141, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-0003, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
New Jersey Medical School
Newark, New Jersey, 07107-3001, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia University/Presbyterian Medical Center
New York, New York, 10032, United States
Harlem Hospital Center
New York, New York, 10037, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 34222, United States
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107-2699, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284, United States
Seattle King County Health Department
Seattle, Washington, 98104, United States
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4, Canada
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8, Canada
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada, Canada
Related 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. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12.
PMID: 14962821BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Weiner, MD
Audie L. Murphy VA Medical Center, San Antonio TX
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
September 6, 2001
First Posted
September 10, 2001
Study Start
March 1, 2000
Study Completion
May 1, 2001
Last Updated
September 13, 2005
Record last verified: 2005-09