Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

April 2, 2009 updated by: Banaras Hindu University

A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates

Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Muzaffarpur, India, 842001
        • Kala-azar Medical Research Center, Rambag Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and adults 2-65 years of age (inclusive) of either gender.
  • Diagnosis of VL confirmed by spleen or bone marrow aspirate.
  • Clinical signs and symptoms compatible with VL.
  • Biochemical and haematological test values as follows:
  • Haemoglobin > 3.5g/100mL
  • White blood cell count > 0.75 x109/L
  • Platelet count > 40 x 109/L
  • AST, ALT and alkaline phosphatase < 5 times upper normal limit
  • Prothrombin time < 4 seconds above control
  • Serum creatinine levels - 1.5 times upper normal limit
  • Serum potassium levels within normal limits
  • HIV negative.

Exclusion Criteria:

  • A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.
  • Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
  • Proteinuria (> 2+).
  • A history of allergy or hypersensitivity to amphotericin B
  • Previous treatment for VL within two weeks of enrollment into the study.
  • Prior treatment failures with amphotericin B.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
a single dose of 10 mg/kg of liposomal amphotericin B
Drug: Liposomal Amphotericin B
a single dose of 10 mg/kg of liposomal amphotericin B
Other Names:
  • AmBisome
Active Comparator: 2
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Final cure rate at six months after the end of treatment
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Initial cure after the end of treatment
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banaras Hindu University

Investigators

  • Study Director: Shyam Sundar, MD, Banaras Hindu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2009

Last Update Submitted That Met QC Criteria

April 2, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA KAMRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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