- Target disease: VL
- Main partners (since project start): BRAZIL: Rene Rachou Research Center– Fiocruz-MG, Belo Horizonte; Paediatric Hospital Joao Paulo II – FHEMIG, Belo Horizonte; Brasilia University; Montes Claros State University; Piaui Federal University, Teresina; Sergipe Federal University, Aracaju; Leishmaniasis Control Programme/Ministry of Health; Universidade Estadual do Rio de Janeiro; Hospital Sao José de Doencas Infecciosas, Fortaleza.
- Project start: February 2011
- Funding (since project start): Associação Bem-Te-Vi Diversidade, Brazil; CNPq/FINEP; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; Medicor Foundation, Liechtenstein; Ministry of Health, Brazil; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.
In 2011, a Phase IV study sponsored by the Brazilian Ministry of Health (FINEP) was initiated at five sites in Brazil to evaluate the efficacy and safety of Amphotericin B deoxycholate, AmBisome®, and a combination of AmBisome® and Glucantime®, in comparison to Glucantime®, the existing first-line treatment of VL. 378 patients were recruited. Brazil’s national guidelines for VL were revised in 2013 based on the interim safety data from the trial. While Glucantime® remains the first-line treatment, AmBisome® replaced Amphotericin B deoxycholate as a second-line treatment.
The Brazilian Ministry of Health is reviewing its policy with regard to the adoption of AmBisome® as first-line treatment for VL.
The final results of this trial were presented to the Ministry of Health, and are expected to guide further policy change in Brazil as of 2017.
Last update: March 2018