Tuberculosis Clinical Trial
Official title:
TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children Receiving Once Weekly Rifapentine and Isoniazid for the Treatment of Latent Tuberculosis Infection
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 rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.
Status | Completed |
Enrollment | 230 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
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: |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hopital Universitario Clementino Fraga Filho | Rio de Janeiro | |
Canada | Montreal Chest Institute | Montreal | Quebec |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | University of Manitoba | Winnepeg | Manitoba |
Spain | Agencia de Salut Publica | Barcelona | |
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Boston University Medical Center | Boston | Massachusetts |
United States | Northwestern University School of Medicine | Chicago | Illinois |
United States | Denver Public Health Department | Denver | Colorado |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of North Texas Health Science Center | Fort Worth | Texas |
United States | Hines Veterans Administration Medical Center | Hines | Illinois |
United States | Houston Veterans Administration Medical Center | Houston | Texas |
United States | Central Arkansas Veterans Health System | Little Rock | Arkansas |
United States | University of Southern California Medical Center | Los Angeles | California |
United States | Veterans Administration Tennessee Valley Health Care System | Nashville | Tennessee |
United States | Columbia University | New York | New York |
United States | New Jersey School of Medicine | Newark | New Jersey |
United States | Audie L. Murphy VA Hospital | San Antonio | Texas |
United States | University of California at San Diego | San Diego | California |
United States | University of California, San Francisco | San Francisco | California |
United States | Seattle-King County Health Department | Seattle | Washington |
United States | Washington DC Veterans Administration Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | VA Office of Research and Development |
United States, Brazil, Canada, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine whether rifapentine exposure (level 24 hours after drug ingestion) is equivalent in young children receiving weight-based dosing to adults receiving 900 mg. | 24 hours after drug ingestion | No | |
Secondary | Correlate estimated rifapentine exposure with toxicity in young children receiving rifapentine and isoniazid for latent tuberculosis infection. | During the three months of taking rifapentine | Yes | |
Secondary | Validate the accuracy of estimated rifapentine exposure with pediatric rifapentine dose based on weight. | 24 hours after drug ingestion | No | |
Secondary | Determine estimated drug bioavailability in pediatric subjects (ages 2 to < 12 years) given higher mg/kg doses of rifapentine. | 24 hours after drug ingestion | No | |
Secondary | Determine the association in adults between polymorphisms of MDR1 genotype (P-glycoprotein) and rifapentine estimated exposure. | at the time of blood draw | No | |
Secondary | 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. | at the time of blood draw | No |
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