drugset / Trial / NCT00216346

Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

NCT00216346

Phase 3 Completed 667 enrolled PATH World Health Organization · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2003-06
Primary completion
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 1 mg/kg Intravenous
Subject Paromomycin Small molecule 11 mg/kg Intramuscular