Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.

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

Details

• Lead Sponsor: PATH
• Collaborator: World Health Organization
• Treatments: Amphotericin B; Liposomal amphotericin B; Paromomycin

Criteria

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.