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Beta-2 Microglobulin and Serum Cytokines x HAART

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ClinicalTrials.gov Identifier: NCT00831207
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : January 28, 2009
Sponsor:
Collaborator:
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Information provided by:
UPECLIN HC FM Botucatu Unesp

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.

Condition or disease
HIV Patients

Detailed Description:

Objective: To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic, clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α, IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+ lymphocytes tests were performed.

Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic failure, genotyping.


Study Design
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Study Type : Observational
Actual Enrollment : 109 participants
Time Perspective: Cross-Sectional
Official Title: Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure
Study Start Date : August 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
G1
15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3.
G2
31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF).
G3
43 HIV-1+ individuals undergoing HAART with TF.
G4
20 normal individuals who served as controls for serum cytokines.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure. [ Time Frame: At subject enrollment. ]

Secondary Outcome Measures :
  1. To assess the behavior of serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure. [ Time Frame: At subject enrollment. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
89 HIV-1-infected individuals assisted by the Tropical Diseases Sector of the Botucatu School of Medicine - UNESP and 20 normal blood donors at the Botucatu Blood Bank.
Criteria

Inclusion Criteria:

  • HIV-1-infected individuals
  • Over 18 years old
  • Sign the "written consent form" (WCF)

Exclusion Criteria:

  • Do not presenting other immunosuppression causes, such as neoplasias, transplantations
  • Do not presenting treatment by immunosuppressive substances
  • Do not presenting auto-immune diseases
  • Not be using any type of immunostimulating substances
  • Not at any time of gestation
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00831207


Locations
Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, Sao Paulo, Brazil, 18618-970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Investigators
Principal Investigator: Ricardo MB Almeida, MSc Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ricardo Augusto Monteiro de Barros Almeida, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
ClinicalTrials.gov Identifier: NCT00831207     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-19
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Keywords provided by UPECLIN HC FM Botucatu Unesp:
B-2 microglobulin
Serum cytokines
HIV-1
Resistance
 HAART
Therapeutic failure
Genotyping.