- Target disease: Chagas
- Main partners (since project start): IS Global, Institute for Global Health, Spain; McGill University, Canada; London School of Hygiene and Tropical Medicine, UK; CEA/Leti, France; Médecins Sans Frontières; Universidad Mayor de San Simon, Bolivia;University of Georgia Research Foundation, USA; Universidad Autónoma Juan Misael Saracho, Bolivia; Barcelona Centre for International Health Research, Spain; Dr Mario Fatala Chaben National Institute of Parasitology, Argentina; University of Texas at El Paso, USA; National Council of Scientific and Technological Research (INGEBI-CONICET), Argentina; Texas Biomedical Research, USA; University Hospitals of Geneva, Switzerland; NHEPACHA network; Universidad San Martin, Argentina.
- Project start: 2010
- Funding (since project start): Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; Médecins Sans Frontières/Doctors without Borders, International; Ministry of Health, Brazil; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Wellcome Trust, UK; Other private foundations and individuals.
A Phase II Proof of Concept study of fexinidazole was initiated in 2014 in Cochabamba and Tarija, Bolivia. A total of 47 patients were included, but the study was interrupted due to safety and tolerability issues. Analyses of key outcomes demonstrated high efficacy findings at the lowest dose tested and for all treatment durations, with safety concerns about treatment at high doses tested for more than 14 days. In addition, acceptable safety and tolerability were found at low doses and short treatment durations. Taken together, these results warrant further investigation of fexinidazole for Chagas disease.
DNDi is collaborating with the University of Georgia and the Texas Biomedical Research Institute in a Wellcome Trust funded, non-human primate study in naturally infected animals with chronic Chagas disease, to further determine PCR and other markers as sensitive tools to consistently differentiate parasitological cure from treatment failure. The dosing period of the non-human primate study in naturally infected animals with chronic Chagas disease ended in 2015, and a 12-month follow-up assessment was completed in August 2015. The study immunosuppression phase was initiated in October 2015 and will end in mid-2016, at which point blood and tissue sample PCR and assessment of other biomarkers will be undertaken to determine if they can differentiate parasitological cure from treatment failure.
DNDi is a member of the NHEPACHA network of investigators created for the long-term cohort evaluation of potential biomarkers.
Last update: August 2017