Leishmaniasis Development

 

  • Target disease: HIV/VL co-infection
  • Main partners (AfriCoLeish): Gondar University Hospital, Ethiopia; Addis Ababa University, Ethiopia; London School of Hygiene and Tropical Medicine, UK; Institute of Tropical Medicine Antwerp, Belgium; Médecins Sans Frontières, the Netherlands; Uppsala University, Sweden; Gilead Sciences, USA; LEAP; the Netherlands Cancer Institute, the Netherlands; Utrecht University, the Netherlands; BaseCon, Denmark; UBC, Switzerland.
  • Project start: September 2011
  • Funding (since project start): European Union – Specific International Scientific Cooperation Activities (FP7); Federal Ministry of Education and Research (BMBF through KfW), Germany; Médecins Sans Frontières/Doctors without Borders, International; Medicor Foundation, Liechtenstein; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.

 

Overall Objective:

  • Identify and deliver a safe and highly effective treatment for VL in HIV co-infected patients that will improve long-term survival of these patients.

 

In 2014, a Phase III study testing both AmBisome® monotherapy (at a higher dose than current practice) and a combination of AmBisome® and miltefosine was initiated at two sites in Ethiopia for the treatment of HIV/VL co-infection. After 132 patients had been enrolled, recruitment was interrupted at the time of the second interim analysis, as efficacy at the end of treatment was lower than expected. Patients who had not achieved cure at the end of treatment were given a second cycle of the same treatment.

With the extended treatment duration, results achieved with the combination treatment were found to be very promising, with the majority of patients achieving VL cure. These results were based on a limited number of patients; a new HIV/VL study is therefore under consideration to confirm the results.

 

Last update: February 2017