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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876824
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : June 2, 2011
Ministry of Science and Technology
Information provided by:
Bharat Serums and Vaccines Limited

Brief Summary:
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 or disease Intervention/treatment Phase
Leishmaniasis, Visceral Drug: Amphotericin B Lipid emulsion Drug: Liposomal Amphotericin B Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : July 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months [ Time Frame: Six months after dose administration ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876824

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Muzaffarpur, Bihar, India, 842001
Muzaffarpur, Bihar, India, 842003
Patna, Bihar, India, 800001
Patna, Bihar, India, 800007
Sponsors and Collaborators
Bharat Serums and Vaccines Limited
Ministry of Science and Technology
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Principal Investigator: Dr. Gautam Daftary, MBBS Bharat Serums and Vaccines Ltd
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Gautam V. Daftary, Bharat Serums and Vaccines Ltd Identifier: NCT00876824    
Other Study ID Numbers: BSV-AMBE III-KA-0908
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011
Keywords provided by Bharat Serums and Vaccines Limited:
Black Fever
Amphotericin B lipid emulsion
Liposomal Amphotericin B
Additional relevant MeSH terms:
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Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents