Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine (VLNAC)
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|ClinicalTrials.gov Identifier: NCT01138956|
Recruitment Status : Unknown
Verified April 2010 by Hospital Universitário Professor Edgard Santos.
Recruitment status was: Recruiting
First Posted : June 8, 2010
Last Update Posted : June 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Visceral Leishmaniasis Immune Response Treatment||Drug: N-acetylcysteine Drug: Pentavalent antimonial||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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 :||April 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||December 2011|
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
- Patient recovery from the visceral leishmaniasis after treatment [ Time Frame: 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.
- Immune response of visceral leishmaniasis patients after proposed treatment [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|