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

NCT00497601 | Completed Phase 2

• 1 other identifier: BSV-AMBE II-KA-706
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 2.To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Conditions

Visceral Leishmaniasis

Keywords

Visceral Leishmaniasis; Amphotericin B; Fat emulsion

Outcome Measures

Primary Outcomes (1)

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

  one year

Study Arms (4)

A

EXPERIMENTAL

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

Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion

B

EXPERIMENTAL

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

Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion

C

EXPERIMENTAL

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

Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion

D

EXPERIMENTAL

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

Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion

Interventions

Amphotericin B fat emulsion in visceral leishmaniasis DRUG

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

Also known as: Amphomul

A; B; C; D

Amphotericin B fat emulsion DRUG

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

Also known as: Amphomul

A; B; C; D

Amphotericin B in fat emulsion DRUG

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

Also known as: Amphomul

A; B; C; D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Kala-azar Medical Research Center

Muzaffarpur, Bihar, 842001, India

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Amphotericin B; soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Shyam Sundar

  Banaras Hindu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 12, 2008

Record last verified: 2008-09

Locations

IN (1)