Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Inclusion Criteria: * Age between 5-55 years (inclusive) of either gender. * Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate. * Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly. * Biochemical and haematological test values as follows: * Haemoglobin \> 5.0g/100mL * White blood cell count \> 1 x109/L * Platelet count \> 50 x 109/L * AST, ALT and alkaline phosphatase \< 3 times upper normal limit * Prothrombin time \< 5 seconds above control * Serum creatinine levels within normal limits * 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 central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study. * Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up. * An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction. * Proteinuria (\> 2+). * A history of allergy or hypersensitivity to aminoglycosides. * A history of major surgery within the last two weeks. * Pregnancy or lactation. \[Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.\] * Previous treatment for VL within two weeks of enrolment into the study. * Prior treatment failures with paromomycin or amphotericin B.