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

Hospital Universitário Professor Edgard Santos

Status: Unknown

Conditions: Immune Response; Treatment; Visceral Leishmaniasis

Treatments: Drug: Pentavalent antimonial; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01138956

VLNAC

Details and patient eligibility

About

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 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

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine

Group 2

Active Comparator group

Description:

Pentavalent antimonial, 20mg/kg/day, 28 days

Treatment:

Drug: Pentavalent antimonial