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

Treatment Clinical Trial

— VLNAC  

Official title:

Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01138956
• Other study ID #: VLNAC
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2010
• Last updated: June 7, 2010
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2010
• Source: Hospital Universitário Professor Edgard Santos
• Contact: Roque P Almeida, MD, PhD
• Phone: 5579-21051806
• Email: roquepacheco[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Immune Response
• Leishmaniasis
• Leishmaniasis, Visceral
• Treatment
• Visceral Leishmaniasis

Intervention

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

Locations

Country	Name	City	State
Brazil	University Hospital	Aracaju	Sergipe

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient recovery from the visceral leishmaniasis after treatment	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.	6 months	No
Secondary	Immune response of visceral leishmaniasis patients after proposed treatment	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.	one year	No