TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
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ClinicalTrials.gov Identifier: NCT00023387 |
Recruitment Status
:
Completed
First Posted
: September 10, 2001
Last Update Posted
: September 13, 2005
|
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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 |
---|---|---|
Tuberculosis | Drug: Rifapentine Drug: 25-desacetyl Rifapentine Drug: Isoniazid | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 36 participants |
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 : | March 2000 |
Study Completion Date : | May 2001 |

- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023387

Principal Investigator: | Marc Weiner, MD | Audie L. Murphy VA Medical Center, San Antonio TX |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00023387 History of Changes |
Other Study ID Numbers: |
CDC-NCHSTP-2558 TBTC Study 25PK |
First Posted: | September 10, 2001 Key Record Dates |
Last Update Posted: | September 13, 2005 |
Last Verified: | September 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 |