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Beta-2 Microglobulin and Serum Cytokines x HAART

This study has been completed.
Sponsor:
Collaborator:
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00831207
First received: December 26, 2008
Last updated: January 27, 2009
Last verified: January 2009

December 26, 2008
January 27, 2009
August 2004
November 2005   (final data collection date for primary outcome measure)
To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure. [ Time Frame: At subject enrollment. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831207 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Beta-2 Microglobulin and Serum Cytokines x HAART
Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure

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.

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.

Observational
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

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.

HIV Patients
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
December 2008
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00831207
upeclin/HC/FMB-Unesp-19
Yes
Ricardo Augusto Monteiro de Barros Almeida, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
UPECLIN HC FM Botucatu Unesp
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Principal Investigator: Ricardo MB Almeida, MSc Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.
UPECLIN HC FM Botucatu Unesp
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP