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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023387
First received: September 6, 2001
Last updated: September 9, 2005
Last verified: September 2005

September 6, 2001
September 9, 2005
March 2000
Not Provided
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
Not Provided
Complete list of historical versions of study NCT00023387 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tuberculosis
  • Drug: Rifapentine
  • Drug: 25-desacetyl Rifapentine
  • Drug: Isoniazid
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
May 2001
Not Provided

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00023387
CDC-NCHSTP-2558, TBTC Study 25PK
Not Provided
Not Provided
Centers for Disease Control and Prevention
Department of Veterans Affairs
Principal Investigator: Marc Weiner, MD Audie L. Murphy VA Medical Center, San Antonio TX
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP