Status:
COMPLETED
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
Lead Sponsor:
Banaras Hindu University
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
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 liposo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00628719
Start Date
February 1 2008
End Date
March 1 2009
Last Update
April 3 2009
Active Locations (1)
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1
Kala-azar Medical Research Center, Rambag Road
Muzaffarpur, India, 842001