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.
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 efficacy, safety or pharmacokinetics of rifapentine in children. This
lack of data has precluded till now enrollment of children less than 12 years old in 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, a phase 3 treatment trial that will enroll 8000 persons with latent tuberculosis
infection. A recently completed initial evaluation of rifapentine pharmacokinetics among
children receiving a single dose of rifapentine demonstrated significantly lower exposures
of rifapentine among children compared to adults, when children were given weight-based
doses chosen to be comparable to a 600 mg oral dose in adults. This reduced exposure
suggested that children require higher weight-based doses than adults and a model was
constructed to estimate rifapentine doses in children that would result in exposures similar
to the 900 mg dose used for adults in Study 26. Study 26 has been amended to include
children ages 2-11 based on the initial single-dose study and pharmacokinetic modeling. The
purpose of Study 26PK is to evaluate the adequacy of the doses chosen for young children who
enrolled in Study 26.
Briefly, this study aims to:
- determine whether rifapentine exposure is equivalent in young children receiving
weight-based dosing to adults receiving 900 mg.
- correlate rifapentine exposure with toxicity in young children
- validate accuracy of weight-based dosing in children
- determine rifapentine bioavailability in children
- determine association in adults between polymorphisms of MDR1 genotype and rifapentine
exposure
- correlate isoniazid concentrations in adults with acetylator status
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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