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Miltefosine for Brazilian Visceral Leishmaniasis

This study has been terminated.
(accrual criteria being reviewed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378495
First Posted: September 20, 2006
Last Update Posted: July 12, 2016
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.
Collaborator:
AEterna Zentaris
Information provided by:
AB Foundation
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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
Study Completion Date: October 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00378495


Locations
Brazil
Universidade Estadual de Montes Claros
Montes Claros, Brazil
Sponsors and Collaborators
AB Foundation
AEterna Zentaris
Investigators
Principal Investigator: Reynaldo Dietze Núcleo de Doenças Infecciosas - UFES
  More Information

ClinicalTrials.gov Identifier: NCT00378495     History of Changes
Other Study ID Numbers: D-18506-Z019
First Submitted: September 18, 2006
First Posted: September 20, 2006
Last Update Posted: July 12, 2016
Last Verified: January 2011

Keywords provided by AB Foundation:
miltefosine
kala azar
Brazil

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