LEAP: Contributing to Strengthening Clinical Trial Capacity, Treatment and Control of VL in Eastern Africa Asrat Hailu, LEAP Chair, Addis Ababa University WorldLeish6 Congress, Toledo, Spain

Leishmaniasis East Africa Platform (LEAP) LEAP - is a clinical research network that brings together experts from leishmaniasis endemic eastern African countries to facilitate clinical testing and improved access to better treatments for leishmaniasis in the region. SUDAN: Univ. of Khartoum Federal Ministry of Health Study sites: Gondar (Eth) Arbaminch (Eth) Abdurafi (Eth) Kassab (Sudan) Dooka (Sudan) Um el kher (Sudan) Amudat (Uganda) Kimalel (Kenya) Kacheliba (Kenya) ETHIOPIA: Addis Ababa Univ. Gondar Univ. Ministry of Health KENYA: KEMRI Ministry of Health UGANDA: Makerere Univ. Ministry of Health

Leishmaniasis East Africa Platform (LEAP) Membership - approx. 60 individual members, representing over 20 institutions Founded in 2003 in Khartoum, Sudan Membership is drawn from the four African countries most affected by visceral leishmaniasis (Ethiopia, Kenya, Sudan, Uganda) as well as international experts. Founded in 2003 with support from DNDi LEAP Objective: “…conduct clinical testing and facilitate improved access to better treatments for leishmaniasis in the region”

LEAP Activities - Capacity Building Lab Upgrading Training Infrastructure Research High standard of research in endemic areas Combination treatment delivered More in the pipeline Clinical research in difficult field conditions

LEAP Activities – Access/Advocacy Working with community leaders & governments Media coverage and advocacy Supporting treatment LEAP meetings

The Numbers 10 Clinical Trials 13 Scientific Publications 7,578 patients VL patients treated within and outside clinical studies (2010-2015) Over 800 staff received Short-term trainings Over 20 Long-term trainings No. VL cases (Jan.2014 – May 2016) Site Average VL cases per month Gondar 39 Kacheliba 25 Doka 15 Arba Minch, Amudat 10 Kimalel 9

Clinical studies since inception Year Study Enrolled Phase COMPLETED STUDIES 2004-2010 SSG&PM 1149 Phase III 2009-2011 AmBisome® single dose 124 Phase II 2010-2012 AmBisome® /SSG/ miltefosine 151 2011-2013 PV study 3126 Phase IV 2013-2014 fexinidazole 14 2015-2016 Urine study 55 Diagnostic 2014-2016 VL/HIV study 60 miltefosine PK 30 UPCOMING STUDIES 2017 miltefosine PM To enroll 546

One treatment delivered, recommended, implemented 17 day combination treatment Recommended as first line treatment in East Africa by WHO in 2010 National VL treatment Guidelines revised Supporting treatment access strategies for SSG&PM Easy to use Affordable Field-adapted Non-patented

Advantages of LEAP Collaboration Combined burden of neglected disease- can do more together with less resources. Development of regional clinical trial capacity hat will contribute to sustainable capacity strengthening No duplication of effort – research priorities avoiding duplication Registration - can leverage on regional registration initiative Development of joint proposals making sourcing of research funds easier Research owned by members, hence trusted by community and governments (e.g. regulatory authorities). Governments readily give support thus easier translation of research results into policy

Future perspectives: strengthening LEAP 2003-2016 Made progress in fulfilling mandate (achievements-clinical trials, publications, capacity building & strengthening, policy change) There have been challenges Need to strengthen the platform Revisit existing governance structure and membership More visibility in countries More priority on access, policy and advocacy for leish New Rationale for LEAP, opportunity to address challenges: New DNDi Business Plan 2015-2023; ARO Strategic Plan 2016-2023 (treatment, policy, NCEs..) Extended VL portfolio (VL, CL, PKDL, Phase 1-4 trials, access, advocacy…) Existing opportunities for expansion, inclusion of new partners in the platform Opportunities for innovative partnerships, new alliances (governments, industry, other stakeholders)

Acknowledgements Study participants and the communities LEAP Partners Trial Sites and the field team (Nurses and lab technicians, clinical monitors, DSMB) MoH Kenya and Gederaf State, Sudan DNDi Geneva and DNDi Africa Regional Office team

LEAP Partners

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