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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Visceral Leishmaniasis, Immune Response, Treatment

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Pentavalent antimonial


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po. | Drug: N-acetylcysteine<br>* N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days<br>|
| Active Comparator: Group 2<br>Pentavalent antimonial, 20mg/kg/day, 28 days | Drug: Pentavalent antimonial<br>* Pentavalent antimonial, 20mg/kg/day, 28 days, IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visceral leishmaniasis, N-acetylcysteine, Antimony, Immune response