- Target disease: HIV/VL co-infection
- Main partners (AfriCoLeish): Addis Ababa University, Ethiopia; BaseCon, Denmark; Gilead Sciences, USA; Gondar University Hospital, Ethiopia; Institute of Tropical Medicine Antwerp, Belgium; LEAP; London School of Hygiene & Tropical Medicine, UK; Médecins Sans Frontières, Spain; Médecins Sans Frontières, The Netherlands; Netherlands Cancer Institute, The Netherlands; Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), India; Sanofi, France; UBC, Switzerland; Uppsala University, Sweden; Utrecht University, The Netherlands.
- Project start: September 2011
- Funding (since project start): Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), The Netherlands; 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.
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.
The results of a study of AmBisome and miltefosine combination therapy efficacy in co-infected patients in Ethiopia showed an 88% cure rate with a second round of treatment to clear Leishmania parasites. A scientific paper sharing the results was published in PLOS NTDs in January 2019 and should support discussions with other stakeholders to support a new treatment recommendation for VL in people co-infected with HIV. Preliminary results are promising from a Phase III study sponsored by MSF and testing the same combination regimen in India, where DNDi is a technical partner with the Rajendra Memorial Research Institute (RMRI).
Main efficacy results were presented to the Ethiopian authorities and WHO in Addis Ababa, Ethiopia, in June and December 2017, to promote the implementation of the combination of AmBisome® and miltefosine as first line treatment for HIV/VL co-infected patients, using the strategy of one or two treatment cycles. A scientific paper should be published in 2018 and open the discussions with other stakeholders to support new recommendation for HIV/VL co-infection.
In India, DNDi is technical partner with the Rajendra Memorial Research Institute (RMRI) in a study sponsored by MSF and launched in Bihar in 2017. This Phase III study will test Ambisome monotherapy and Ambisome in combination with miltefosine in 150 patients. 113 patients have been included so far. Recruitment is expected to be completed by early 2018. Results will inform the national road map of kala-azar elimination in India.
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 2019