Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the
 treatment of Visceral Leishmaniasis (VL) in India.
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the
 treatment of VL in India.

 Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal
 amphotericin B to amphotericin B deoxycholate with regards to final cure rates

 Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal
 amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage
 regimens.
Inclusion Criteria:

 -  Children and adults 2-65 years of age (inclusive) of either gender.

 -  Diagnosis of VL confirmed by spleen or bone marrow aspirate.

 -  Clinical signs and symptoms compatible with VL.

 -  Biochemical and haematological test values as follows:

 -  Haemoglobin > 3.5g/100mL

 -  White blood cell count > 0.75 x109/L

 -  Platelet count > 40 x 109/L

 -  AST, ALT and alkaline phosphatase < 5 times upper normal limit

 -  Prothrombin time < 4 seconds above control

 -  Serum creatinine levels - 1.5 times upper normal limit

 -  Serum potassium levels within normal limits

 -  HIV negative.

 Exclusion Criteria:

 -  A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or
 drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis;
 other infectious or major psychiatric diseases) that may introduce variables that
 affect the outcome of the study.

 -  Any condition which the investigator thinks may prevent the patient from completing
 the study therapy and subsequent follow-up.

 -  Proteinuria (> 2+).

 -  A history of allergy or hypersensitivity to amphotericin B

 -  Previous treatment for VL within two weeks of enrollment into the study.

 -  Prior treatment failures with amphotericin B.