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

NCT00832208 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2016-01-21

No results posted yet for this study

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.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Liposomal amphotericin B (Ambisome)

21.0 mg/kg total dose. Given iv as 3mg/kg/day on days 1,2,3,4,5, and 14 and 21

DRUG

Liposomal amphotericin B (Ambisome)

liposomal amphotericin b given intravenously as single dose at 7.5 mg/kg increasing to 10, 12.5 and 15.0mg/kg depending on results of interim analyses.

Sponsors & Collaborators

  • Addis Ababa University

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Sisay Yifru, MD · Gondar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-09-30
Completion
2011-03-31

Countries

  • Ethiopia
  • Sudan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832208 on ClinicalTrials.gov