drugset / Trial / NCT00696969

Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis

NCT00696969

Phase 3 Completed 634 enrolled Drugs for Neglected Diseases
RandomizedParallel-groupOpen-labelTreatment

Summary

The overall objective of this trial is to identify a safe and effective combination, (coadministration) short course treatment for the treatment of visceral leishmaniasis which could be easily deployed in a control programme and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed.

Timeline

Start
2008-06
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 5 mg/kg Intravenous
Subject Miltefosine Small molecule 50 mg Oral
Subject Paromomycin Small molecule 15 mg/kg Intramuscular
Comparator amphotericin B deoxycholate Unknown 1 mg/kg Intravenous