Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Visceral Leishmaniasis Clinical Trial

Official title:

A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628719
• Other study ID #: AA KAMRC
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2008
• Last updated: April 2, 2009
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Banaras Hindu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

Description:

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.

Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates

Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 65 Years

Eligibility

Inclusion Criteria:

• Children and adults 2-65 years of age (inclusive) of either gender.

• Diagnosis of VL confirmed by spleen or bone marrow aspirate.

• Clinical signs and symptoms compatible with VL.

• Biochemical and haematological test values as follows:

• Haemoglobin > 3.5g/100mL

• White blood cell count > 0.75 x109/L

• Platelet count > 40 x 109/L

• AST, ALT and alkaline phosphatase < 5 times upper normal limit

• Prothrombin time < 4 seconds above control

• Serum creatinine levels - 1.5 times upper normal limit

• Serum potassium levels within normal limits

• HIV negative.

Exclusion Criteria:

• A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.

• Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.

• Proteinuria (> 2+).

• A history of allergy or hypersensitivity to amphotericin B

• Previous treatment for VL within two weeks of enrollment into the study.

• Prior treatment failures with amphotericin B.

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
• Visceral Leishmaniasis

Intervention

Drug:
• Liposomal Amphotericin B
a single dose of 10 mg/kg of liposomal amphotericin B
• amphotericin B deoxycholate
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.

Locations

Country	Name	City	State
India	Kala-azar Medical Research Center, Rambag Road	Muzaffarpur

Sponsors (1)

Lead Sponsor	Collaborator
Banaras Hindu University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final cure rate at six months after the end of treatment		One year	Yes
Secondary	Initial cure after the end of treatment		six months	Yes