Miltefosine for Brazilian Visceral Leishmaniasis

This study has been terminated.
(accrual criteria being reviewed)
Sponsor:
Collaborator:
AEterna Zentaris
Information provided by:
AB Foundation
ClinicalTrials.gov Identifier:
NCT00378495
First received: September 18, 2006
Last updated: January 18, 2011
Last verified: January 2011
  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
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.

  Eligibility

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on April 17, 2014