CLINICAL TRIAL WITH LIPOSOMAL AMPHOTERICIN B (AMBISOME®) FOR AMERICAN VISCERAL LEISHMANIASIS (AVL)
Graça M.C. Viana, Ana C.R. Saldanha, Clélia R. Pinheiro, Jeanne d’Arc L. Nascimento, Marcelo N. Burattini, Jackson M.L. Costa
Resumo
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.
Key words: Leishmania chagasi, visceral leishmaniasis, liposomal amphotericin B, Northeastern of Brazil.
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.
Key words: Leishmania chagasi, visceral leishmaniasis, liposomal amphotericin B, Northeastern of Brazil.
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