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

Overview

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.

Full Title of Study: “Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2011

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

Interventions

  • Drug: N-acetylcysteine
    • N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
  • Drug: Pentavalent antimonial
    • Pentavalent antimonial, 20mg/kg/day, 28 days, IV

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
  • Active Comparator: Group 2
    • Pentavalent antimonial, 20mg/kg/day, 28 days

Clinical Trial Outcome Measures

Primary Measures

  • Patient recovery from the visceral leishmaniasis after treatment
    • Time Frame: 6 months
    • 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 Measures

  • Immune response of visceral leishmaniasis patients after proposed treatment
    • Time Frame: one year
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitário Professor Edgard Santos
  • Provider of Information About this Clinical Study
    • Roque Pacheco de Almeida, Universidade Federal de Sergipe
  • Overall Official(s)
    • Roque P Almeida, MD, PhD, Principal Investigator, Hospital Universitário
  • Overall Contact(s)
    • Roque P Almeida, MD, PhD, 5579-21051806, roquepacheco@uol.com.br

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