Miltefosine for Brazilian Visceral Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378495
Recruitment Status : Terminated (accrual criteria being reviewed)
First Posted : September 20, 2006
Last Update Posted : July 12, 2016
AEterna Zentaris
Information provided by:
AB Foundation

Brief Summary:
Miltefosine will be administered to Brazilian patients with kala azar

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine

Primary Outcome Measures :
  1. cure rate at 6 months

Secondary Outcome Measures :
  1. cure rate at 1 month
  2. safety

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00378495     History of Changes
Other Study ID Numbers: D-18506-Z019
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: January 2011

Keywords provided by AB Foundation:
kala azar

Additional relevant MeSH terms:
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents