Miltefosine for Brazilian Visceral Leishmaniasis

Inclusion Criteria: * Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture. * Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years * Sex: male and female patients eligible (no effort to be made to balance the study for gender) Exclusion Criteria: Exclusion criteria Safety concerns: * Thrombocyte count \<30 x 109/l; * Leukocyte count \<1 x 109/l; * Hemoglobin \<5 g/100 ml; * ASAT, ALAT, AP \>3 times upper limit of normal range; * Serum creatinine or BUN \>1.5 times upper limit of normal range; * Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary); * Immunodeficiency or antibody to HIV; * Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus); * Any non-compensated or uncontrolled condition; * Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months. Lack of suitability for the trial: * Negative bone marrow aspirate (smear); * Any history of prior anti-leishmania therapy; * Any condition which compromises ability to comply with the study procedures; * Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria). Administrative reasons: * Lack of ability or willingness to give informed consent (patient and/or parent / legal representative); * Anticipated non-availability for study visits/procedures.