Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

NCT00628719 | Completed Phase 3

• 1 other identifier: AA KAMRC
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis; India; Liposomal Amphotericin B; Amphotericin B deoxycholate

Outcome Measures

Primary Outcomes (1)

• Final cure rate at six months after the end of treatment

  One year

Secondary Outcomes (1)

• Initial cure after the end of treatment

  six months

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Liposomal Amphotericin B

2

ACTIVE COMPARATOR

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.

Drug: amphotericin B deoxycholate

Interventions

Liposomal Amphotericin B DRUG

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

Also known as: AmBisome

1

amphotericin B deoxycholate 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.

2

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Kala-azar Medical Research Center, Rambag Road

Muzaffarpur, 842001, India

Location

Related Publications (1)

• 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.

  PMID: 20147716 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

liposomal amphotericin B; amphotericin B, deoxycholate drug combination

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Shyam Sundar, MD

  Banaras Hindu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: March 1, 2009
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

IN (1)