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A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar

NCT00497601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-09-12

No results posted yet for this study

Summary

The purpose of this study is:

1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations.
2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Amphotericin B fat emulsion in visceral leishmaniasis

Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D

DRUG

Amphotericin B fat emulsion

Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1

DRUG

Amphotericin B in fat emulsion

Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1

Sponsors & Collaborators

  • Banaras Hindu University

    lead OTHER

Principal Investigators

  • Shyam Sundar · Banaras Hindu University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-07-31
Completion
2008-07-31

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 NCT00497601 on ClinicalTrials.gov