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No. 4, 2011

CLINICAL RESEARCH BRANCH UPDATES

Rifapentine and Isoniazid for LTBI: 12-Dose DOT Regimen

The TBTC Study 26 (PREVENT TB) manuscript was published in December 2011.  This article reports the main outcome of this decade-long, 8,000-patient, international study conducted by the CDC-sponsored Tuberculosis Trials Consortium. This and other recent studies support the publication of guidelines in CDC’s MMWR for use of this 12-dose regimen for treatment of latent TB infection (LTBI). Details are in the article, “Guidelines Released on New, Shorter Regimen for LTBI,” which can be found in the News from the Division of Tuberculosis Elimination section of this issue.

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Rifapentine for Pulmonary TB: Finding the Right Dose

On November 2, 2011, TBTC Study 29X started to enroll patients at sites in the United States (11 sites), Brazil, Hong Kong, Kenya, Peru, South Africa (2 sites), Spain, Uganda, and Vietnam. This phase 2 study will evaluate the safety and bioavailability of three different doses of daily (7 days/week) rifapentine as a substitute for rifampin, given with food, and administered with isoniazid, pyrazinamide, and ethambutol during intensive phase treatment of sputum smear–positive pulmonary TB. Patients and investigators are blinded to rifapentine dose by using matching placebo tablets. Study 29X will enroll 80 patients in each of four arms: rifampin, rifapentine 10 mg/kg, rifapentine 15 mg/kg, and rifapentine 20 mg/kg. It is an extension of TBTC Study 29, which evaluated a single dose (10mg/kg) given only 5 days per week and without food (food augments rifapentine absorption). The goal of these studies is to confirm in humans the very promising results seen in murine studies, suggesting that high-dose daily rifapentine could provide a basis for substantial shortening of TB treatment, and thus provide the rationale for proceeding to a phase 3 trial of a treatment-shortening regimen for drug-sensitive TB.

—Reported by Stefan Goldberg, MD
Div of TB Elimination

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