1. 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

2. 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

3. 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”

4. 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

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

6. The Numbers 10 Clinical Trials 13 Scientific Publications
7,578 patients VL patients treated within and outside clinical studies ( )
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

7. Clinical studies since inception
Year
Study
Enrolled
Phase
COMPLETED STUDIES
SSG&PM
1149
Phase III
AmBisome® single dose
124
Phase II
AmBisome® /SSG/ miltefosine
151
PV study
3126
Phase IV
fexinidazole 14
Urine study 55
Diagnostic
VL/HIV study 60
miltefosine PK 30
UPCOMING STUDIES
2017
miltefosine PM
To enroll 546

8. 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

9. 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

10. Future perspectives: strengthening LEAP
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 ; ARO Strategic Plan (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)

11. 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

12. LEAP Partners

13. THANK YOU
TO ALL OUR
Donors to the LEAP Platform by

14. Give neglected patients a voice. They exist and must be heard.
Thank you.