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.