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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:
Centers for Disease Control and Prevention
Collaborator:
VA Office of Research and Development
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
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Purpose
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 | Intervention |
|---|---|
| Tuberculosis | Drug: Rifapentine Drug: 25-desacetyl Rifapentine Drug: Isoniazid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Tuberculosis
Drug Information available for:
Rifapentine
U.S. FDA Resources
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | May 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00023387
Show 23 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023387
Show 23 Study Locations
Sponsors and Collaborators
Centers for Disease Control and Prevention
VA Office of Research and Development
Investigators
| Principal Investigator: | Marc Weiner, MD | Audie L. Murphy VA Medical Center, San Antonio TX |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00023387 History of Changes |
| Other Study ID Numbers: |
CDC-NCHSTP-2558 TBTC Study 25PK |
| Study First Received: | September 6, 2001 |
| Last Updated: | September 9, 2005 |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Isoniazid Rifapentine Rifampin Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Antibiotics, Antitubercular Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |
ClinicalTrials.gov processed this record on July 27, 2017