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No. 4, 2012

CLINICAL RESEARCH BRANCH UPDATES

First Study Participant Is Successfully Enrolled into TBTC Study 33!

Elsa Villarino, TB Trials Consortium (TBTC) Lead, and Andrey Borisov, Project Officer, are pleased to announce that on Sept. 18, the first participant was successfully enrolled into TBTC Study 33! This study, called iAdhere, is evaluating self-administration of the 12-dose latent TB infection (LTBI) regimen. It is an open label, randomized, controlled clinical trial conducted in multiple sites (USA, Spain, South Africa, Brazil, and Hong Kong) in patients diagnosed with LTBI.  The primary objective of the trial is to evaluate adherence to a 3-month (12-dose) regimen of weekly rifapentine and isoniazid (3HP) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). Treatment completion is the primary outcome; adherence will be assessed by self-report, pill counts, and medication event monitoring system (MEMS) caps. Secondary objectives of this clinical trial include evaluation of the use of weekly short messaging service (SMS) reminders as an intervention to maximize the adherence to SAT, and collection and evaluation of adverse events among patients receiving the new 3HP LTBI therapy. The trial plans to enroll about 1,000 patients (primarily in the USA) to be randomized into DOT, standard SAT, or enhanced SAT with weekly SMS reminders study arms. The study will be completed in 2013; results of the study will be used as the basis for policy concerning use of the 12-dose (3HP) regimen as a self-administered therapy. More information about the study can be found at http://clinicaltrials.gov/show/NCT01582711

—Reported by Andrey Borisov
Div of TB Elimination

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