GLOBAL HEALTH | GLOBAL PARTNERSHIPS | GLOBAL IMPACT

Research

Photo for STOP CHAGAS

STOP CHAGAS

Official Title

Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease

Status

Ongoing

Overview

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.

Study Design

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.

Primary Endpoint

The primary efficacy endpoint for this trial is the proportion of subjects who show a successful response for the POS versus placebo comparison.

Number of Patients

120

Number of Sites

17

Number of Countries

6

Study Period

2011–2015

Principal Investigator

Carlos Morillo

Program Manager

Susan Chrolavicius, Brandi Meeks

Research Coordinator

Amanda Gilbert, Laura Bonilla

Collaborators

Merck