Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banaras Hindu University
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Liposomal amphotericin B

Criteria

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.