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No. 2, 2012


TBTC Evaluation of Rifapentine for Treatment of Pulmonary TB

The Tuberculosis Trials Consortium is enrolling TBTC Study 29x, a dose-escalation extension of TBTC Study 29, “Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis,” at 20 sites in the United States, Brazil, Hong Kong, Kenya, Peru, South Africa, Spain, Uganda, and Viet Nam.  The protocol chair is Dr. Susan Dorman at Johns Hopkins University.  The results of these randomized controlled phase 2 trials, associated pharmacokinetic studies, and related studies of rifapentine sponsored by other institutions that currently are in progress, will be evaluated to determine whether and how to conduct a future phase 3 study of rifapentine in a 3- or 4-month regimen to cure pulmonary TB.

Study 29 enrolled 531 adults with sputum smear-positive pulmonary TB, from December 8, 2008, to November 5, 2010, and randomized participants to rifapentine 10 mg/kg/dose or rifampin 10 mg/kg/dose, administered 5 days/week for 8 weeks (intensive phase), with isoniazid, pyrazinamide, and ethambutol. Co-primary outcomes were negative sputum culture on liquid and on solid media at intensive phase completion. According to these culture measures, the rifapentine regimen was as safe and effective as the rifampin regimen, and supported evaluation of higher rifapentine exposures. The Study 29 manuscript been accepted for publication in a high-impact journal.

Study 29x is enrolling 320 patients in a four-arm phase 2 evaluation of the tolerability of higher doses of rifapentine, administered with isoniazid, pyrazinamide, and ethambutol, during intensive phase treatment of sputum smear-positive pulmonary TB. Rifapentine exposure is being optimized by treating 7 days/week and administering doses with high-fat meals. In addition to the study arm with a standard rifampin dose, rifapentine study arms have doses of 10 mg/kg, 15 mg/kg, and 20 mg/kg. As in Study 29, continuation phase treatment follows ATS/CDC guidelines.  Enrollment is now past the half-way mark and is expected to be complete by the end of this year.

—Reported by Stefan Goldberg, MD
Div of TB Elimination

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