Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With 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.