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

Sponsor

Hospital Universitário Professor Edgard Santos (Other)

Overall Status

Unknown status

CT.gov ID

NCT01138956

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Visceral Leishmaniasis Immune Response Treatment	Drug: N-acetylcysteine Drug: Pentavalent antimonial	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Patient recovery from the visceral leishmaniasis after treatment [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 [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.