TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00164450
• Date of registration: 10/09/2005
• Primary sponsor: Centers for Disease Control and Prevention
• Public title: TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
• Scientific title: TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children Receiving Once Weekly Rifapentine and Isoniazid for the Treatment of Latent Tuberculosis Infection
• Date of first enrolment: September 2005
• Target sample size: 230
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00164450
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Brazil, Canada, Spain, United States

Contacts

• Name: Marc Weiner, MD
• Affiliation: VAMC and University of Texas Health Science Center San Antonio

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. 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 Criteria:

- None



Age minimum: 2 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Drug: Rifapentine + isoniazid once weekly for 3 months

Primary Outcome(s)

Determine whether rifapentine exposure (level 24 hours after drug ingestion) is equivalent in young children receiving weight-based dosing to adults receiving 900 mg. [Time Frame: 24 hours after drug ingestion]

Secondary Outcome(s)

Correlate estimated rifapentine exposure with toxicity in young children receiving rifapentine and isoniazid for latent tuberculosis infection. [Time Frame: During the three months of taking rifapentine]

Determine estimated drug bioavailability in pediatric subjects (ages 2 to < 12 years) given higher mg/kg doses of rifapentine. [Time Frame: 24 hours after drug ingestion]

Determine the association in adults between polymorphisms of MDR1 genotype (P-glycoprotein) and rifapentine estimated exposure. [Time Frame: at the time of blood draw]

Determine the frequency of lower antitubercular drug concentrations in adults with acetylator status determined by N-acetyltransferase genotypes and of rifapentine by C24 and by MDR1 genotypes. [Time Frame: at the time of blood draw]

Validate the accuracy of estimated rifapentine exposure with pediatric rifapentine dose based on weight. [Time Frame: 24 hours after drug ingestion]

Secondary ID(s)

CDC-NCHSTP-4679

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Department of Veterans Affairs