Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine (VLNAC)
Recruitment status was Recruiting
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.
Drug: Pentavalent antimonial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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|
- Patient recovery from the visceral leishmaniasis after treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Immune response of visceral leishmaniasis patients after proposed treatment [ Time Frame: one year ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Group 1
Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138956
|Contact: Roque P Almeida, MD, PhDfirstname.lastname@example.org|
|Contact: Enaldo V Melo, MDemail@example.com|
|Aracaju, Sergipe, Brazil, 49060-100|
|Contact: Roque P Almeida, MD, PhD 5579-21051806 firstname.lastname@example.org|
|Contact: Enaldo V Melo, MD 5579-21051700 email@example.com|
|Sub-Investigator: Angela M Silva, MD,PhD|
|Principal Investigator:||Roque P Almeida, MD, PhD||Hospital Universitário|