Miltefosine for Brazilian Visceral Leishmaniasis

This study has been terminated.
(accrual criteria being reviewed)
AEterna Zentaris
Information provided by:
AB Foundation Identifier:
First received: September 18, 2006
Last updated: January 18, 2011
Last verified: January 2011
Miltefosine will be administered to Brazilian patients with kala azar

Condition Intervention Phase
Kala Azar
Drug: Miltefosine: initially 2.5 mg/kg/day for 28 days
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by AB Foundation:

Primary Outcome Measures:
  • cure rate at 6 months

Secondary Outcome Measures:
  • cure rate at 1 month
  • safety

Estimated Enrollment: 80
Study Start Date: April 2005
Estimated Study Completion Date: October 2007
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00378495

Universidade Estadual de Montes Claros
Montes Claros, Brazil
Sponsors and Collaborators
AB Foundation
AEterna Zentaris
Principal Investigator: Reynaldo Dietze Núcleo de Doenças Infecciosas - UFES
  More Information Identifier: NCT00378495     History of Changes
Other Study ID Numbers: D-18506-Z019 
Study First Received: September 18, 2006
Last Updated: January 18, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by AB Foundation:
kala azar

Additional relevant MeSH terms:
Anti-Infective Agents
Antifungal Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents processed this record on May 26, 2016