Status:
TERMINATED
Miltefosine for Brazilian Visceral Leishmaniasis
Lead Sponsor:
AB Foundation
Collaborating Sponsors:
AEterna Zentaris
Conditions:
Kala Azar
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Miltefosine will be administered to Brazilian patients with kala azar
Detailed Description
Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00378495
Start Date
April 1 2005
End Date
October 1 2007
Last Update
July 12 2016
Active Locations (1)
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1
Universidade Estadual de Montes Claros
Montes Claros, Brazil