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Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

NCT00371995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-06-22

No results posted yet for this study

Summary

Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Liposomal amphotericin B and Miltefosine

Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)

Sponsors & Collaborators

  • Rajendra Memorial Research Institute of Medical Sciences

    collaborator OTHER

  • Banaras Hindu University

    lead OTHER

Principal Investigators

  • Shyam Sundar, MD · Banaras Hindu University

  • Prabhat K Sinha, MD · Rajendra Memorial Research Institute of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-08-31
Completion
2010-02-28

Countries

  • India

Study Locations

More Related Trials

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 NCT00371995 on ClinicalTrials.gov