Clinical Research Detail Title Of Study Single dose study of Liposomal Amphotericin (Ambisome). Disease Condition Kala-azar has a worldwide distribution affecting 88 countries of five continents with a total of 350 million people at risk and 90% of them belonged to five countries namely Bangladesh, Brazil, India, Nepal and Sudan. In the Indian Subcontinent the three countries affected by VL, India, Nepal and Bangladesh, aspire to eliminate Visceral leishmaniasis (VL) from the subcontinent by 2015 through various control measures. One of the important components in this endeavor is decreasing transmission through effective treatment. In the hyperendemic regions of India and adjoining areas of Nepal, traditionally effective antileishmanial drug sodium stibogluconate (Pentavalent antimony, Sb) is fast losing its efficacy with the result that about two thirds of patients in some of these areas are refractory to Sb treatment. Pentamidine, a diamidine compound, was first to be used in patients refractory to Sb, and cured every patient initially, but over a decade its efficacy declined from ~100% to 70%. Now, intravenous infusions of amphotericin B are used in India. as a first line antileishmanial drug in these areas and this necessitates hospitalisation for prolonged periods limiting the number of patients which can be treated, in addition infusion reactions are very common and occasional serious adverse events like nephrotoxicity, myocarditis, and deaths can occur with this drug. Ambisome is a liposomal formulation of amphotericin B, associated with significantly lower renal toxicity than amphotericin B, which is dose-limiting. It is an effective and well tolerated drug licenced for treatment of VL in India.AmBisome is the safest and probably the most efficacious of all anti-leishmanial drugs currently available. In more recent studies Thakur et al, (2001), and Sundar et al. (2001, 2003) have demonstrated the efficacy and safety of AmBisome achieving efficacy rates in excess of 90% in single doses of 5-15mg/kg. In studies conducted in Bihar earlier, Liposomal amphotericin B has efficacy of more than 90% . Phase of Trial Phase-2 & 3 Discipline Pharmacology Start date of Trial 3/3/2010 Closing Date of Trial 3/3/2011 If you are a doctor interested in clinical research then upload your profile. Click here If you are a hospital interested in clinical research then upload your profile. Click here If you are a patient interested to know more about this clinical trial mail us at:   [email protected]