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

Leishmaniasis, Visceral Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876824
• Other study ID #: BSV-AMBE III-KA-0908
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2009
• Last updated: June 1, 2011
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Bharat Serums and Vaccines Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral

Intervention

Drug:
• Amphotericin B Lipid emulsion
Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis
• Liposomal Amphotericin B
Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bharat Serums and Vaccines Limited	Ministry of Science and Technology

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months		Six months after dose administration	No
Secondary	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		within 30 to 45 days from drug administration and continue throughout duration of study	Yes