Overview

Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL

Status:
Terminated

Trial end date:
2011-03-01

Target enrollment:

Participant gender:

Summary

This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.

Phase:

Phase 2

Details

Lead Sponsor:

Drugs for Neglected Diseases

Collaborator:

Addis Ababa University

Treatments:

Amphotericin B
Liposomal amphotericin B