New VL treatments (VL in Asia)
| • Target disease: VL • Major Partners: INDIA: National Vector Borne Disease Control Programme (NVBDCP), Indian Medical Research Council (ICMR), Delhi; Rajendra Memorial Research Institute of Medical Sciences (RMRIMSI), Patna, Bihar State Health Society (BSHS); Médecins Sans Frontières (MSF), Spain. BANGLADESH: Ministry of Health, International Centre for Diarrhoeal Disease Research (ICDDR, B), Dhaka; Shaheed Suhrawardy Medical College and Hospital (ShSMC), Dhaka; Community Based Medical College (CBMC), Mymensingh. USA: OneWorld Health (OWH), San Francisco. University of Tokyo, Japan; Institute Tropical Medicine-Antwerp, Belgium; LSHTM, UK; WHO Special Programme for Research and Training in Tropical Diseases (TDR) • Management: Head of Leishmaniasis Clinical Programme, Jorge Alvar; Clinical Manager, Sally Ellis; Head of DNDi India, Bhawna Sharma; Project Coordinator: Vishal Goyal; Assistants: Pankaj Kumar, Abhijit Sharma • Project Phase III start: December 2006 • Project Phase III end: January 2010 • Project Pilot Implementation: March 2011 • Funding: Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; The Starr International Foundation, Switzerland |
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Objectives: Conduct effectiveness studies in South Asia to demonstrate feasibility in implementing the new treatment modalities recommended by WHO (miltefosine-paromomycin, AmBisome®-miltefosine, AmBisome®-paromomycin, AmBisome® 10mg/kg) in primary healthcare settings in India with a view to extending their use in the region. Support control and elimination strategies in the countries of highest prevalence in South Asia. The Phase III trial conducted by DNDi and its partners in 2010 demonstrated the efficacy of combination therapies based on AmBisome®, miltefosine, and paromomycin. An additional study by Sundar et al.(1) showed the efficacy of single-dose AmBisome ® given as an intravenous infusion. To facilitate the introduction of these new treatments for VL in South Asia, DNDi developed a partnership consortium with TDR and OWH(2), in collaboration with health authorities at state, national, and regional levels. DNDi will work to implement single dose AmBisome® in the public sector in India (with TDR) and new combination therapies in the private sector (with OWH). Effectiveness studies are being implemented in the region to demonstrate that such treatments can be safely implemented through primary healthcare systems in both the public and the private sectors. These studies include: • A pilot project in the Bihar State of India implementing combination therapies at the primary healthcare level and single-dose AmBisome® at the hospital level. The project has two main components, surveillance and pharmacovigilance to monitor treatment effectiveness and safety in the public sector. In 2011, approvals were obtained from key stakeholders in India, an agreement was signed with the Bihar State, and partnerships were established with local implementing organizations. The study is expected to begin mid-2012. • A two-step Phase III study (first in hospital settings, then in primary healthcare centres) using the combination therapies in Bangladesh; recruitment started in July 2010 and is continuing. Last update: December 2012 |
| DNDi's role and projects in the VL South Asia Consortium TDR's role and projects in the VL South Asia Consortium OneWorldHealth's role in the VL South Asia Consortium |
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