• Major Partners: Kenya Medical Research Institute (KEMRI), Kenya; Institute of Endemic Diseases (IED), University of Khartoum, Sudan; Addis Ababa University, Ethiopia; Gondar University, Ethiopia; University of Makerere, Uganda; London School of Hygiene and Tropical Medicine (LSHTM), UK; ASK (AMC, Slotervaart Hospital, KIT), The Netherlands; Ministries of Health of Ethiopia, Sudan, Kenya, and Uganda; Médecins Sans Frontières (MSF); i+ solutions, The Netherlands; OneWorld Health (OWH), USA; LEAP (Leishmaniasis East Africa Platform))

• Management: Head of Leishmaniasis Clinical Programme, Manica Balasegaram; Clinical Manager, Sally Ellis

• Funding: Médecins Sans Frontières/Doctors without Borders, International; Spanish Agency for International Development Cooperation (AECID), Spain; Department for International Development (DFID), UK; Region of Tuscany, Italy; Ministry of Foreign and European Affairs (MAEE), France; République and Canton de Genève, Switzerland; Fondation André & Cyprien, Switzerland; a private foundation, and individual donors.

Status: This project was initiated to register paromomycin in East Africa and evaluate its use in a shorter-course combination with SSG as an improved treatment for VL. In 2010, the Leishmaniasis East Africa Platform (LEAP) completed this multi-centre, multicountry clinical trial sponsored by DNDi in Kenya, Ethiopia, Sudan, and Uganda. The LEAP 0104 study involved over 1,100 VL patients and showed that a short-course combination of PM (15mg/kg/day) and SSG (20mg/kg/day) had a similar safety and efficacy profile (efficacy at 6 months follow up post-treatment > 90%) as the standard SSG monotherapy treatment (SSG 20mg/kg/day for 30 days). The trial also demonstrated that the use of PM (15 or 20 mg/ kg/day) alone for 21 days resulted in significantly lower efficacy. Thus the use of the combination will be critical to prolonging the use of both drugs in the region, particularly PM. In March 2010, the WHO Expert Committee on the Control of Leishmaniases recommended SSG&PM as first-line treatment for visceral leishmaniasis in East Africa. A few months later, Sudan was the first country to apply the recommendation and implement SSG&PM to treat patients (end 2010). DNDi and LEAP will continue the process of ensuring the registration of paromomycin in the region in order to further implement the recommendation of SSG&PM as first-line treatment regimen for VL.