To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar - Full Text View

Sponsor:	Bharat Serums and Vaccines Limited
Collaborator:	Ministry of Science and Technology
Information provided by:	Bharat Serums and Vaccines Limited
ClinicalTrials.gov Identifier:	NCT00876824

Purpose

The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).

Condition	Intervention	Phase
Leishmaniasis, Visceral	Drug: Amphotericin B Lipid emulsion Drug: Liposomal Amphotericin B	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Lipids Amphotericin B

U.S. FDA Resources

Further study details as provided by Bharat Serums and Vaccines Limited:

Primary Outcome Measures:

Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months [ Time Frame: Six months after dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the Number of AEs, SAEs, Incidence of IRTs, with no Incidence of nephrotoxicity and hepatotoxicity and no change in the Laboratory values for different parameters [ Time Frame: within 30 to 45 days from drug administration and continue throughout duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	500
Study Start Date:	July 2009
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Amphotericin B lipid emulsion Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion	Drug: Amphotericin B Lipid emulsion Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis Other Name: Amphomul
Active Comparator: Liposomal Amphotericin B Liposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B	Drug: Liposomal Amphotericin B Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B Other Name: AmBisome

Detailed Description:

Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious, chronic disease that is characterized by irregular fever, anorexia, weight loss, cough, gross enlargement of the spleen and liver, mild anemia and emaciation. This may be preceded by rigors and vomiting. If untreated, Kala-azar, which is the most severe form of Leishmaniasis, has a mortality rate of nearly 100%.

The goal of the project is to establish that a single dose of AMPHOMUL® can be used to achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more affordable than current treatment, and is without the risk of drug resistance.

The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either treatment naive or treatment resistant to other antileishmanial drugs.

Eligibility

Ages Eligible for Study:	5 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients aged between 5 to 65 years (both inclusive).
Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly)
Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by rK39 dipstick test with confirmation by splenic or bone marrow aspirate smear examination.
Non-pregnant, non-lactating females of age ≥5 years, and woman of childbearing potential who are willing to use acceptable methods of contraception
Negative Urine pregnancy test (UPT) in all women

Exclusion Criteria:

Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening.
Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history).
Concurrent diabetes, tuberculosis or bacterial pneumonia or any other infectious or major psychiatric disease.
Pregnant or nursing women
Patients receiving any of the medications prohibited by the study protocol.
Simultaneous participation in another trial or received any IP <30 days prior to enrolment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876824

Locations

India

Muzaffarpur, Bihar, India, 842001

Muzaffarpur, Bihar, India, 842003

Patna, Bihar, India, 800007

Patna, Bihar, India, 800001

Sponsors and Collaborators

Bharat Serums and Vaccines Limited

Ministry of Science and Technology

Investigators

Principal Investigator:

Dr. Gautam Daftary, MBBS

Bharat Serums and Vaccines Ltd

More Information

No publications provided

Responsible Party:	Dr. Gautam V. Daftary, Bharat Serums and Vaccines Ltd
ClinicalTrials.gov Identifier:	NCT00876824 History of Changes
Other Study ID Numbers:	BSV-AMBE III-KA-0908
Study First Received:	April 6, 2009
Last Updated:	June 1, 2011
Health Authority:	India: Drugs Controller General of India; India: Ministry of Science and Technology

Keywords provided by Bharat Serums and Vaccines Limited:

Black Fever
Kala-Azar
Amphotericin B lipid emulsion
Liposomal Amphotericin B

Additional relevant MeSH terms:

Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B

Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012