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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bharat Serums and Vaccines Limited
• Collaborator: Ministry of Science and Technology
• Treatments: Amphotericin B; Liposomal amphotericin B

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.