An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety and efficacy of three different doses/dose regimens of paromomycin administered intramuscularly as follows: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the treatment of visceral leishmaniasis (VL) in India.

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

Details

• Lead Sponsor: Banaras Hindu University
• Treatments: Paromomycin

Criteria

Inclusion Criteria:

• Children and adults, male or female, aged 5 to 55 years, inclusive, who have provided written informed consent.

• New or relapsed VL or prior VL treatment failure on a regimen not containing Paromomycin or AmBisome®. The diagnosis of VL must be confirmed by a parasite-positive splenic aspirate.

Exclusion Criteria:

• LFT greater than 3 times ULN ( AST, ALT, S.Bilirubin, Alkaline Phosphatase, Hb < 4 gm/dl.

• Platelet <40,000/ mm3

• Prothrombin Time > 3 Sec. longer than Control.

• Creatinine > 3 times

• Normal Value For Male ( 0.6 to 1.1)

• Normal Value For Female ( 0.5 to 0.9)

• Absolute Leucocyte count- < 1,000

• HIV infection

• Abnormal audiometric and/or vestibular dysfunction

• History of renal dysfunction

• Other severe medical conditions

• History of allergy or hypersensitivity to aminoglycosides

• Treatment with a parenteral aminoglycoside within 28 days prior to randomisation

• Previous VL treatment within the past 14 days

• Previous treatment for VL with paromomycin at any time

• Pregnancy, lactation, or lack of use of contraception in women of childbearing potential