Status:
COMPLETED
TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Tuberculosis
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifape...
Detailed Description
The pharmacokinetics of rifapentine have been studied in adults, adolescents (ages 12-15 years), and patients with hepatic dysfunction and HIV infection. However, there are no published data on the ef...
Eligibility Criteria
Inclusion
- Enrolled in TBTC Study 26 randomized to treatment with once weekly isoniazid and rifapentine:
- Child between the ages of 2 to less than 12 years for whom informed consent by a guardian and of assent (if applicable) have been obtained.
- Adult greater than age 18 for whom informed consent has been obtained.
- Willingness to undergo a blood phlebotomy 24 hours following dosing of isoniazid and rifapentine after receiving at least three once-weekly doses of rifapentine plus isoniazid.
- If as a result of a contact investigation, both a parent and child are enrolled in Study 26, both may be co-enrolled into the pharmacokinetic substudy with the adult serving as the control for the child. Preference will be given to a biologic parent of the same gender. If no eligible biologic parent is available for study, the next adult of the same gender and at the same TBTC site, who is substudy eligible, will serve as the adult control.
Exclusion
- None
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00164450
Start Date
September 1 2005
End Date
August 1 2008
Last Update
August 25 2008
Active Locations (24)
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1
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States, 72205
2
University of Southern California Medical Center
Los Angeles, California, United States, 90033
3
University of California at San Diego
San Diego, California, United States, 92103
4
University of California, San Francisco
San Francisco, California, United States, 94110