CDC announces first participant in TBTC study

The TB Trials Consortium recently announced that it had enrolled its first participant in TBTC Study 33, an evaluation of the self-administration of a 12-dose latent tuberculosis infection regimen.

The iAdhere study is an open label, randomized, controlled clinical trial conducted in Hong Kong, Brazil, South Africa, Spain and the United States in patients diagnosed with LTBI.

Elsa Villarino, TBTC's lead, and Andrey Borisov, Study 33's project officer, announced the enrollment as part of the Centers for Disease Control and Prevention's end of the year issue of TB Notes.

The primary objective of the study is to evaluate how well participants adhere to a three-month, 12-dose regimen of weekly isoniazid and rifapentine given by directly observed therapy compared to self-administered therapy.

The researchers will assess adherence by pill counts, self-reports and medication event monitoring system caps.

Secondary objectives of the trial include the collection and evaluation of adverse events among patients receiving the new 3HP LTBI therapy and evaluation of the use of weekly short messaging service reminders as an effort to enhance the adherence to SAT.

TBTC plans to enroll approximately 1,000 patients in the trial to be randomized into DOT, standard SAT or enhanced SAT with weekly SMS reminders.

Results from the study will be used to inform policy related to use of the 12-dose regimen for SAT.

The study will be completed in 2013.