Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine (VLNAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Hospital Universitário Professor Edgard Santos.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01138956
First received: June 7, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.


Condition Intervention
Visceral Leishmaniasis
Immune Response
Treatment
Drug: N-acetylcysteine
Drug: Pentavalent antimonial

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Patient recovery from the visceral leishmaniasis after treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The cure is defined in the patient with reduced spleen and liver. Absence of fever for more than 15 days after treatment, weight gain, normalization of globulins and resolution of leukopenia and anemia.


Secondary Outcome Measures:
  • Immune response of visceral leishmaniasis patients after proposed treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
    Evaluation of the Immune response: peripheral blood mononuclear cells of patients are being obtained in ficoll-Hypaque gradient and stimulated in vitro with soluble antigen of L. chagasi to evaluate the production of cytokines (IFN-g, TNF-a. IL-10, TGF-b) before treatment, 15, 45, 180 and 360 days afterwards.


Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
Drug: N-acetylcysteine
N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
Active Comparator: Group 2
Pentavalent antimonial, 20mg/kg/day, 28 days
Drug: Pentavalent antimonial
Pentavalent antimonial, 20mg/kg/day, 28 days, IV

Detailed Description:

In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment

  Eligibility

Ages Eligible for Study:   2 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 2 to 50 years
  • Diagnosis of visceral leishmaniasis

Exclusion Criteria:

  • Other acute or chronic diseases
  • Use of immunosuppressive drugs
  • AIDS
  • History of allergy to NAC and/or pentavalent antimony
  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: NCT01138956

Contacts
Contact: Roque P Almeida, MD, PhD 5579-21051806 roquepacheco@uol.com.br
Contact: Enaldo V Melo, MD 5579-21051700 evm.estatistica@gmail.com

Locations
Brazil
University Hospital Recruiting
Aracaju, Sergipe, Brazil, 49060-100
Contact: Roque P Almeida, MD, PhD    5579-21051806    roquepacheco@uol.com.br   
Contact: Enaldo V Melo, MD    5579-21051700    evm.estatistica@gmail.com   
Sub-Investigator: Angela M Silva, MD,PhD         
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Investigators
Principal Investigator: Roque P Almeida, MD, PhD Hospital Universitário
  More Information

No publications provided

Responsible Party: Roque Pacheco de Almeida, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT01138956     History of Changes
Other Study ID Numbers: VLNAC
Study First Received: June 7, 2010
Last Updated: June 7, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitário Professor Edgard Santos:
Visceral leishmaniasis
N-acetylcysteine
Antimony
Immune response

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on July 22, 2014