NCT01138956

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Universitário Professor Edgard Santos · Academic / Other
• Sex: All
• Age: 2 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Visceral Leishmaniasis
• Immune Response
• Treatment

Interventions

Type	Name	Description
DRUG	N-acetylcysteine	N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
DRUG	Pentavalent antimonial	Pentavalent antimonial, 20mg/kg/day, 28 days, IV

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2010-06-08
• Last updated: 2010-06-08

Locations

1 site across 1 country: Brazil