Back to results

Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Primary Purpose

Visceral Leishmaniasis

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Liposomal Amphotericin B

amphotericin B deoxycholate

About this trial

This is an interventional treatment trial for Visceral Leishmaniasis focused on measuring Visceral leishmaniasis, India, Liposomal Amphotericin B, Amphotericin B deoxycholate

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kala-azar Medical Research Center, Rambag Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Final cure rate at six months after the end of treatment

Secondary Outcome Measures

Initial cure after the end of treatment

Full Information

NCT ID

NCT00628719

First Posted

February 20, 2008

Last Updated

April 2, 2009

Sponsor

Banaras Hindu University

1. Study Identification

Unique Protocol Identification Number

NCT00628719

Brief Title

Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Banaras Hindu University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis, India, Liposomal Amphotericin B, Amphotericin B deoxycholate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Liposomal Amphotericin B

Other Intervention Name(s)

AmBisome

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

amphotericin B deoxycholate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Final cure rate at six months after the end of treatment

Time Frame

One year

Secondary Outcome Measure Information:

Title

Initial cure after the end of treatment

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shyam Sundar, MD

Organizational Affiliation

Banaras Hindu University

Official's Role

Study Director

Facility Information:

Facility Name

Kala-azar Medical Research Center, Rambag Road

City

Muzaffarpur

ZIP/Postal Code

842001

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

20147716

Citation

Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12. doi: 10.1056/NEJMoa0903627.

Results Reference

derived

Learn more about this trial

Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

We'll reach out to this number within 24 hrs