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New VL treatments - India

Leishmaniasis Implementation

  • Target disease: VL
  • Partners: Indian Medical Research Council (ICMR); Rajendra Memorial Research Institute of Medical Sciences (RMRI), India; Kala Azar Medical Research Centre, India; State Health Society, Bihar (BSHS), India; OneWorld Health (OWH/PATH), USA; WHO-TDR; WHO (SEARO, Geneva); MSF 
  • Leadership: Head of Leishmaniasis Clinical Programme: Jorge Alvar; DNDi India Director of R&D Operations: Bhawna Sharma; Clinical Managers: Fabiana Alves and Vishal Goyal; Project Coordinator: Abhijit Sharma; Assistant Project Coordinator: Pankaj Kumar
  • Project start: 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

  • Objectives: Conduct large-scale effectiveness studies in South Asia to demonstrate feasibility in implementing the new treatment modalities recommended by WHO (miltefosine-paromomycin, AmBisome®-miltefosine, AmBisome®-paromomycin, single-dose AmBisome®) in primary healthcare settings in India with a view to extending their use in the region. Support control and elimination strategies of the country

  • Read DNDi's Press Release on the project
  • Read about it on the WHO-TDR website
  • Listen to audio podcast about the consortium: 2011 interview with consortium partners: Dr. Bhawna Sharma (Head of DNDi India), Sally Ellis (Clinical Manager, DNDi), Dr. Philippe Desjeux (Senior Programme Officer, OWH), and Dr. Byron Arana (Scientist, TDR)

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. 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/PATH, in collaboration with health authorities at state and national 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/ PATH). 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. This includes 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 is monitoring pharmacovigilance as well as treatment effectiveness of the different treatment options when used outside of a clinical trial by the public sector. The study began in 2012 in two districts in India. By the end of the year, 213 patients had been recruited, out of 7,000 planned. The trial is expected to end in 2015 and results will be available in 2016.

Last update: October 2013

Tags: Leishmaniasis
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