Conditions: Chagas Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: no

Brief summary:
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.

Detailed description:

Arms:
arm 1: Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days arm 2: Posaconazole placebo (10 mL) oral suspension twice daily for 60 days arm 3: Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days arm 4: Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days

Interventions: intervention 1: Posaconazole intervention 2: Placebo for posaconazole intervention 3: Benznidazole
Intervention descriptions: intervention 1: POS 40 mg/mL oral suspension intervention 2: Placebo oral suspension intervention 3: BNZ 100 mg oral tablet

Protocol document: