Clinical trial with liposomal amphotericin B (AMBISOME®) for American Visceral Leisshmaniais (AVL)

A prospective, non-randomized study was conducted on 30 patients with American Visceral Leishmaniasis (AVL) aged 3 to 10 years from São Luis, Maranhão - Brazil, who were not previously submitted to treatment. After an informed consent form, was signed by the responsible person, all patients were submitted to anamnesis and physical examination and a standard chart was filled out. The patients were randomly divided into three cohorts of 10 patients each and submitted to the following treatment regimen with liposomal amphotericin B: cohort 1) 2 mg/kg/ day applied on days 1, 2, 3, 4, 5, 6 and 10, total dose of 14 mg/kg; cohort 2) 2 mg/kg/day applied on days 1, 2, 3, 4, and 10, total dose of 10 mg/kg; cohort 3) 2 mg/kg/day applied on days 1, 5, and 10, total dose of 6 mg/kg. An intra-hospital treatment regimen was used which consisted of intravenous administration of the drug over a period of 60 min. Efficacy was 70% in cohort 1, 90% cohort 2, and 80% in cohort 3. The patients were followed up for 6 months. No significant difference was observed between the three regimens in terms of toxicity, tolerability and effectiveness when evaluated by generalizations of the Gehan model and Wilcoxon test