Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Visceral Leishmaniasis

Intervention / Treatment
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* Drug: Liposomal Amphotericin B
* Drug: amphotericin B deoxycholate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>a single dose of 10 mg/kg of liposomal amphotericin B | Drug: Liposomal Amphotericin B<br>* a single dose of 10 mg/kg of liposomal amphotericin B<br>* Other names: AmBisome;|
| Active Comparator: 2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final cure rate at six months after the end of treatment |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial cure after the end of treatment |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visceral leishmaniasis, India, Liposomal Amphotericin B, Amphotericin B deoxycholate