Miltefosine for Brazilian Visceral Leishmaniasis

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Miltefosine will be administered to Brazilian patients with kala azar

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Foundation
• Collaborator: AEterna Zentaris
• Treatments: Miltefosine

Criteria

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.