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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; National Vector Borne Disease Control Programme (NVBDCP), India; Institute of Tropical Medicine-Antwerp, Belgium; 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: December 2006
  • 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

  • Objective: Significant progress in the implementation study

  • 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 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 is carrying out effectiveness studies that are being implemented in the region, including 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 a clinical trial by the public sector. The study began in 2012 in two districts in India. On December 10, the Steering Committee met to evaluate the results. Data was presented on 900 patients enrolled in the pilot phase, of which 467 had completed a 6 month follow up. At the close of the year, a total of 1,122 patients had been enrolled, including 973 at hospitals and 149 PHCs. With the completion of this pilot phase, the Steering Committee recommended entering the implementation phase, which aims to treat 6,000 more patients. The trial is expected to end in 2015 and results will be available in 2016.



Last update: August 2014


Tags: Leishmaniasis
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