references
STRENGTHENING EXISTING CAPACITIES
LEISHMANIASIS EAST AFRICA PLATFORM (LEAP)
Founded: 2003, Khartoum, Sudan Over 60 individual members, representing over 20 institutions
2015 HIGHLIGHTS
• 22nd LEAP meeting in Khartoum, Sudan in October 2015, with 68 participants, with 22nd LEAP principal investigators (PIs) meeting and 1st Project Advisory Committee (PAC) of the AfriCoLeish Project • “New combination treatments for VL in Africa” and Fexinidazole studies completed.
Treatments & Access
Sudan Ethiopia
Uganda
Kenya
LEAP facilitated and organized the Stakeholders and MoH dissemination meetings regarding the pharmacovigilance results of SSG&PM, in Nairobi and in Kampala (Nov.) and reviewed the national guidelines for VL diagnosis and management to clearly state that SSG&PM combination is the new first line treatment for primary VL patients in Eastern Africa.
Clinical trials • Miltefosine pharmacokinetic and safety in children with VL: Completed recruitThe LEAP platform aims to strengthen clinical research capacity, which is lacking in part due to the remoteness and geographic spread of VL patients, most of whom live in the most impoverished regions of Africa. The platform is also a base for ongoing educational cooperation between countries in the East African region and standardization of procedures and practices within the region, as far as is possible within the scope of local regulations. LEAP evaluates, validates, and registers new treatments that address regional needs for VL.
ment, with 30 patients in August 2015 (21 in Kacheliba, Kenya and 9 in Amudat, Uganda). 2 DSMB meetings (July and Oct.) • HIV/VL treatment study: 60 patients recruited by end of 2015 (32 in Gondar and 28 in Abdurafi, Ethiopia). The study is evaluating the efficacy of AmBisome®+miltefosine combination and of a higher-dose AmBisome® monotherapy. 2 DSMB meetings (April and May). Belgium (3), and the OpenClinica Global Conference 2015 in Amsterdam, Netherlands (6).
Communications
The fourth edition of the LEAP Newsletter was published in November 2015.
Capacity strengthening
LEAP organized trainings in Marsabit (with 22 attendees) and Turkana (14) counties, Kenya on the National Diagnosis and Management of VL Guidelines. Protocol specific, Good Clinical Practice (GCP), and GCLP courses were provided to 363 health staff of clinical sites, in Gondar and Abdurafi (Ethiopia), Amudat (Uganda), and Kacheliba (Kenya). Data management events were attended by LEAP members: the 4th ADMIT Workshop organized by the Institute of Tropical Medicine (ITM) in Antwerp,
“I am proud to be part of a team that gained new knowledge through training and participation in a clinical trial for the first time.“
Martin Sunguti Kundu, Lab. head, Kacheliba, West Pokot, Kenya
MEMBERS: Center for Clinical Research, Kenya Medical Research Institute (KEMRI), Kenya; Ministry of Health, Kenya; Institute of Endemic Diseases, University of Khartoum, Sudan; Federal Ministry of Health, Sudan; Addis Ababa University, Ethiopia; Gondar University, Ethiopia; Federal Bureau of Health, Ethiopia; Makerere University, Uganda; Ministry of Health, Uganda; Médecins Sans Frontières; IDA Foundation, The Netherlands; OneWorld Health (OWH/PATH), USA; AMC/KIT/ Slotervaart Hospital, The Netherlands; London School of Hygiene & Tropical Medicine (LSHTM), UK.
58 › DNDi Annual Report 2015