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Completed

NCT Number: NCT00023387

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifapentine

Drug

25-desacetyl Rifapentine

Drug

Isoniazid

Drug

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.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults

Important dates

Study start
2000
Study completion
2001
First posted
Sep 10, 2001
Registry last updated
Sep 13, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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