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.