Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil

Inclusion Criteria: * patients with visceral leishmaniasis characterized by fever plus hepatomegaly or splenomegaly with at least one positive result in the following laboratory tests: * direct observation of leishmania amastigotes in bone marrow smear * leishmania in vitro culture from bone marrow aspirates * leishmania kDNA amplification by PCR in bone marrow or peripheral blood samples * rK39 immunochromatographic rapid test performed on serum sample Exclusion Criteria: * pregnancy * HIV infection * chronic diseases such as diabetes mellitus,kidney, liver or cardiac diseases, schistosomiasis, malaria or tuberculosis * immune disorders or use of drugs which interferes with the immune response * treatment with drugs with increased risk for toxicity associated with the study drugs * exposure to antileishmanial drugs during the past six months * I.V. drug users * episodes of visceral leishmaniasis relapse * hypersensibility to the study drugs * difficulties for accomplishing the follow-up schedule * any of the following clinical signs of laboratory abnormalities: hepatic encephalopathy, generalized edema, toxemic individuals, severe malnutrition, jaundice, abnormal serum creatinine, bilirubin, INR \> 2,0, platelet count \< 20000/mm3