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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Hospital Universitário Professor Edgard Santos.
Recruitment status was:  Recruiting
Information provided by:
Hospital Universitário Professor Edgard Santos Identifier:
First received: June 7, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
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
Drug: N-acetylcysteine
Drug: Pentavalent antimonial

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
    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 ]
    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

Ages Eligible for Study:   2 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01138956

University Hospital
Aracaju, Sergipe, Brazil, 49060-100
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Principal Investigator: Roque P Almeida, MD, PhD Hospital Universitário
  More Information

Responsible Party: Roque Pacheco de Almeida, Universidade Federal de Sergipe Identifier: NCT01138956     History of Changes
Other Study ID Numbers: VLNAC 
Study First Received: June 7, 2010
Last Updated: June 7, 2010

Keywords provided by Hospital Universitário Professor Edgard Santos:
Visceral leishmaniasis
Immune response

Additional relevant MeSH terms:
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on February 20, 2017