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

• Status: Completed
• Trial end date: 2001-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Isoniazid; Rifampin; Rifapentine

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