Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine (VLNAC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Hospital Universitário Professor Edgard Santos.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Universitário Professor Edgard Santos
Information provided by:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01138956
First received: June 7, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Visceral Leishmaniasis Immune Response Treatment |
Drug: N-acetylcysteine Drug: Pentavalent antimonial |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Leishmaniasis
Drug Information available for:
Acetylcysteine
U.S. FDA Resources
Further study details as provided by Hospital Universitário Professor Edgard Santos:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
|
Drug: N-acetylcysteine
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
|
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
Eligibility| Ages Eligible for Study: | 2 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138956
Contacts
| Contact: Roque P Almeida, MD, PhD | 5579-21051806 | roquepacheco@uol.com.br |
| Contact: Enaldo V Melo, MD | 5579-21051700 | evm.estatistica@gmail.com |
Locations
| Brazil | |
| University Hospital | Recruiting |
| Aracaju, Sergipe, Brazil, 49060-100 | |
| Contact: Roque P Almeida, MD, PhD 5579-21051806 roquepacheco@uol.com.br | |
| Contact: Enaldo V Melo, MD 5579-21051700 evm.estatistica@gmail.com | |
| Sub-Investigator: Angela M Silva, MD,PhD | |
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Investigators
| Principal Investigator: | Roque P Almeida, MD, PhD | Hospital Universitário |
More Information
No publications provided
| Responsible Party: | Roque Pacheco de Almeida, Universidade Federal de Sergipe |
| ClinicalTrials.gov Identifier: | NCT01138956 History of Changes |
| Other Study ID Numbers: | VLNAC |
| Study First Received: | June 7, 2010 |
| Last Updated: | June 7, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital Universitário Professor Edgard Santos:
|
Visceral leishmaniasis N-acetylcysteine Antimony Immune response |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 23, 2013