Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease
To evaluate the efficacy and safety of posaconazole and posaconazole in combination with benznidazole given orally for 60 days to reduce parasitemia as measured by qualitative Polymerase Chain Reaction (PCR) at the end of 120 days of follow-up post treatment in subjects with asymptomatic chronic Chagas disease.
Randomized, active and placebo-controlled, POS single-blind but BNZ open-label study of a single dose level of POS given either as monotherapy or in combination with BNZ, in subjects with a diagnosis of asymptomatic chronic Chagas disease.
The primary efficacy endpoint for this trial is the proportion of subjects who show a successful response for the POS versus placebo comparison.
Susan Chrolavicius, Brandi Meeks
Amanda Gilbert, Laura Bonilla
Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol 2017; 69(8): 939-947.