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Home Project Portfolio New VL treatments (Africa)

New VL treatments - Africa

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• Target disease: VL
• 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, 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; OneWorldHealth (OWH), USA; LEAP (Leishmaniasis East Africa Platform))
• Management: Head of Leishmaniasis Clinical Programme, Manica Balasegaram; Clinical Manager, Sally Ellis
• Project start: November 2004
• 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: Due to various limitations such as toxicity, difficulty of use, and the high cost of existing drugs, VL is complex to treat in Africa. Sodium stibogluconate (SSG), a relatively toxic drug requiring a daily regimen of painful injections over 30 days, remains the mainstay of treatment. Other drugs, such as paromomycin (PM) and miltefosine, are neither registered nor available in the region. Since 2004, DNDi and the Leishmaniasis East Africa Platform (LEAP) have embarked on a clinical research programme with two specific objectives: to geographically extend all currently available VL drugs and to develop one to two new treatments. In 2010, the first – a combination therapy – came out of this clinical research programme: SSG&PM.

In addition to the LEAP 0104 study, DNDi also conducted two other clinical trials in the region during 2010 in order to develop a second treatment:


AmBisome® / LEAP 0106 Study
AmBisome®, a liposomal formulation of amphotericin B manufactured by Gilead, is approved to treat VL in Europe and USA. Gilead has worked with the World Health Organization and NGOs to provide AmBisome® at a preferential price for the treatment of leishmaniasis in resource-limited settings. Therefore, the goals of this project are to determine the minimum dose of AmBisome® that is efficacious, safe, and cost-effective in the treatment of VL in Africa, to reduce the length of hospital stays required, and to facilitate the registration and adoption of the drug in the region, in addition to its optimal use in combination therapies. Recruitment for the study was closed at the end of 2010. Results of this study will be presented in 2011.

Miltefosine-AmBisome® / LEAP 0208 Study
This study is to evaluate the safety and efficacy of miltefosine and AmBisome® combination treatment. Recruitment has started in Kenya and Sudan (Q2 2010). Miltefosine, a drug originally developed for the treatment of cancer, is the only orally administered drug against VL. Miltefosine is registered and used in India and in some countries in Latin America. The trial will collect safety, efficacy, and pharmacokinetic data on miltefosine to geographically extend the use of the drug into East Africa. In addition, combination treatments of AmBisome® with either miltefosine or SSG are evaluated. If the results are promising, it will be taken into Phase III development.


Last update: May 2011

 


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