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

Primary Purpose

Visceral Leishmaniasis

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Amphotericin B fat emulsion in visceral leishmaniasis

Amphotericin B fat emulsion

Amphotericin B in fat emulsion

About this trial

This is an interventional treatment trial for Visceral Leishmaniasis focused on measuring Visceral Leishmaniasis, Amphotericin B, Fat emulsion

Eligibility Criteria

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

Inclusion Criteria:

Male or female subjects between 18 years and 65 years of age (both inclusive).
Subject/subject's legally acceptable representative is willing and able to give written informed consent to participate in the study.
Treatment naive subjects having symptoms and/or signs of visceral leishmaniasis with parasitological confirmation of Kala-azar (by splenic or bone marrow aspirate smear examination).

If subjects are previously treated with other antileishmanial drugs except amphotericin B containing preparations, they will be enrolled in the study only after clinical and parasitological evidence that the disease is unresponsive to adequate treatment with other drugs, and after an appropriate wash out period

Exclusion Criteria:

Subjects with past history of treatment with Amphotericin B for Kala-azar.
Subjects positive for HIV infection.
Concomitant life threatening or serious disease.
Concurrent malaria (malarial parasite test to be negative prior to study treatment administration), tuberculosis or bacterial pneumonia.
Haemoglobin < 6 gm/dl, total leukocyte count < 1,500/cmm, platelet count < 50,000/cmm
Abnormal liver and renal functions (BUN and serum creatinine > 1.5 times upper limit of normal (ULN), AST/ALT > 2.5 times ULN, and bilirubin > 1.5 times ULN).
Pregnant or nursing women.
Known hypersensitivity to Amphotericin B or inactive ingredients of study drug formulation.
Subjects receiving any of the medications prohibited by the study protocol.
Evidence of significant haematological, cardiac, hepatic, renal, respiratory, neurological or metabolic disease or any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Simultaneous participation in another trial or received any investigational product < 30 days prior to enrolment.

Sites / Locations

Kala-azar Medical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 and 3

Amphotericin B in fat emulsion (Amphomul) 10 mg/kg on day 1 and 5 mg/kg on day 3

Amphotericin B in fat emulsion (Amphomul) 12.5 mg/kg on day 1 and 2.5 mg/kg on day 3

Amphotericin B in fat emulsion (Amphomul) 15 mg/kg in a single dose administration on day 1

Outcomes

Primary Outcome Measures

Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00497601

First Posted

July 5, 2007

Last Updated

September 11, 2008

Sponsor

Banaras Hindu University

1. Study Identification

Unique Protocol Identification Number

NCT00497601

Brief Title

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

Official Title

A Prospective, Single Center, Open-Label, Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of Visceral Leishmaniasis (Kala-Azar).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (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 study is: 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. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Detailed Description

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. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar. Subjects will be administered the study drug in either of the following four dose levels in an ascending manner, starting with the first dosage regimen: 7.5 mg/kg on day 1 and day3 (Regimen 1) 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2) 12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3) Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)

6. Conditions and Keywords

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

Visceral Leishmaniasis

Keywords

Visceral Leishmaniasis, Amphotericin B, Fat emulsion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 and 3

Arm Title

Arm Type

Experimental

Arm Description

Amphotericin B in fat emulsion (Amphomul) 10 mg/kg on day 1 and 5 mg/kg on day 3

Arm Title

Arm Type

Experimental

Arm Description

Amphotericin B in fat emulsion (Amphomul) 12.5 mg/kg on day 1 and 2.5 mg/kg on day 3

Arm Title

Arm Type

Experimental

Arm Description

Amphotericin B in fat emulsion (Amphomul) 15 mg/kg in a single dose administration on day 1

Intervention Type

Drug

Intervention Name(s)

Amphotericin B fat emulsion in visceral leishmaniasis

Other Intervention Name(s)

Amphomul

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Amphotericin B fat emulsion

Other Intervention Name(s)

Amphomul

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Amphotericin B in fat emulsion

Other Intervention Name(s)

Amphomul

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects between 18 years and 65 years of age (both inclusive). Subject/subject's legally acceptable representative is willing and able to give written informed consent to participate in the study. Treatment naive subjects having symptoms and/or signs of visceral leishmaniasis with parasitological confirmation of Kala-azar (by splenic or bone marrow aspirate smear examination). If subjects are previously treated with other antileishmanial drugs except amphotericin B containing preparations, they will be enrolled in the study only after clinical and parasitological evidence that the disease is unresponsive to adequate treatment with other drugs, and after an appropriate wash out period Exclusion Criteria: Subjects with past history of treatment with Amphotericin B for Kala-azar. Subjects positive for HIV infection. Concomitant life threatening or serious disease. Concurrent malaria (malarial parasite test to be negative prior to study treatment administration), tuberculosis or bacterial pneumonia. Haemoglobin < 6 gm/dl, total leukocyte count < 1,500/cmm, platelet count < 50,000/cmm Abnormal liver and renal functions (BUN and serum creatinine > 1.5 times upper limit of normal (ULN), AST/ALT > 2.5 times ULN, and bilirubin > 1.5 times ULN). Pregnant or nursing women. Known hypersensitivity to Amphotericin B or inactive ingredients of study drug formulation. Subjects receiving any of the medications prohibited by the study protocol. Evidence of significant haematological, cardiac, hepatic, renal, respiratory, neurological or metabolic disease or any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Simultaneous participation in another trial or received any investigational product < 30 days prior to enrolment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shyam Sundar

Organizational Affiliation

Banaras Hindu University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kala-azar Medical Research Center

City

Muzaffarpur

State/Province

Bihar

ZIP/Postal Code

842001

Country

India

12. IPD Sharing Statement

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

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