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.
Age range
2 Years
Sex
ALL
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Rifapentine Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, AUC0-inf
Timeframe: 24 hours after study-drug administration; AUC0-inf estimated using a nonlinear mixed-effects pharmacokinetic model incorporating the 24-hour rifapentine concentration, C24.
Correlation Between Rifapentine C24 and AUC0-inf
Timeframe: 24 hours after study-drug administration