TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
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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 Endpoint Classification: Pharmacokinetics Study 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 |
- Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
- 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 |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00023387
Show 23 Study Locations
| 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 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tuberculosis Actinomycetales Infections Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Rifampin Rifapentine Anti-Bacterial Agents Anti-Infective Agents |
Antibiotics, Antitubercular Antitubercular Agents Enzyme Inhibitors Leprostatic Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015