The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
a single dose of 10 mg/kg of liposomal amphotericin B
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.
Kala-azar Medical Research Center, Rambag Road
Muzaffarpur, India
Final cure rate at six months after the end of treatment
Time frame: One year
Initial cure after the end of treatment
Time frame: six months
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