In planning the study to evaluate posaconazole, Merck has consulted with international agencies and research organizations to identify the current medical needs and reach consensus on a study design for posaconazole in asymptomatic chronic Chagas disease. The proposed study is a randomized, placebo-controlled Phase II study of posaconazole oral suspension (400 mg twice daily) given for 60 days, either as monotherapy or concomitantly with benznidazole. Benznidazole monotherapy will serve as an active control. The study is planned to enroll 160 adult patients with chronic Chagas disease at several sites in South America and follow them for a total of 360 days. The study will utilize polymerase chain reaction (PCR) to evaluate the levels of Trypanosoma cruzi in blood samples as the primary endpoint for response to treatment. Safety will be monitored by an external independent Data and Safety Monitoring Board (DSMB) on an ongoing basis and the DSMB will make recommendations as appropriate. Results from the study are expected in 2012. If successful, Phase III clinical studies with posaconazole would follow. Merck looks forward to working with interested partners to facilitate access if posaconazole is shown to be beneficial in the treatment of chronic Chagas disease.

Source Merck