Leishmaniasis, Visceral Clinical Trial
Official title:
A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).
Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious,
chronic disease that is characterized by irregular fever, anorexia, weight loss, cough,
gross enlargement of the spleen and liver, mild anemia and emaciation. This may be preceded
by rigors and vomiting. If untreated, Kala-azar, which is the most severe form of
Leishmaniasis, has a mortality rate of nearly 100%.
The goal of the project is to establish that a single dose of AMPHOMUL® can be used to
achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The
project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more
affordable than current treatment, and is without the risk of drug resistance.
The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to
Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to
Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either
treatment naive or treatment resistant to other antileishmanial drugs.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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