Status: About 90% of VL cases in Latin America occur in Brazil, and most of them affect children. In 2007, Brazil reported around 3,500 new cases and a fatality rate of 5.4%. DNDi’s objective is to assist the Brazilian Ministry of Health to evaluate the safety and efficacy of Glucantime®, AmBisome®, amphotericin B, and AmBisome® and Glucantime® combination to treat VL patients in Brazil. To this end, a feasibility assessment and VL site selection was performed over 2010, with potential study sites identified in different regions of the country. The broader objectives of the study, led by Dr Gustavo Romero of the University of Brasilia, and sponsored by the Brazilian Ministry of Health, include the assessment of the effectiveness of currently recommended treatments for VL in Brazil. The project is conducted in several reference centres, involving a total of 600 adults and children. The recruitment of patients commenced in Q1 2011.