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
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 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 July 22, 2014