Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

NCT ID: NCT00628719

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-03-31

Brief 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.

Detailed 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.

Conditions

Visceral Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

a single dose of 10 mg/kg of liposomal amphotericin B

Group Type: EXPERIMENTAL

Liposomal Amphotericin B

Intervention Type: DRUG

a single dose of 10 mg/kg of liposomal amphotericin B

2

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.

Group Type: ACTIVE_COMPARATOR

amphotericin B deoxycholate

Intervention Type: DRUG

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.

Interventions

Liposomal Amphotericin B

a single dose of 10 mg/kg of liposomal amphotericin B

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

AmBisome

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Banaras Hindu University

OTHER

Sponsor Role: lead

Responsible Party

Banaras Hindu University

Principal Investigators

Shyam Sundar, MD

Role: STUDY_DIRECTOR

Banaras Hindu University

Locations

Kala-azar Medical Research Center, Rambag Road

Muzaffarpur, , India

Countries

India

References

Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12. doi: 10.1056/NEJMoa0903627.

Reference Type: DERIVED

PMID: 20147716 (View on PubMed)

Other Identifiers

AA KAMRC

Identifier Type: -

Identifier Source: org_study_id