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Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

NCT00628719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2009-04-03

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Liposomal Amphotericin B

a single dose of 10 mg/kg of liposomal amphotericin B

DRUG

amphotericin B deoxycholate

amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.

Sponsors & Collaborators

  • Banaras Hindu University

    lead OTHER

Principal Investigators

  • Shyam Sundar, MD · Banaras Hindu University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-08-31
Completion
2009-03-31

Countries

  • India

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 NCT00628719 on ClinicalTrials.gov