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Beta-2 Microglobulin and Serum Cytokines x HAART

U

UPECLIN HC FM Botucatu Unesp

Status

Completed

Conditions

HIV Patients

Study type

Observational

Funder types

Other

Identifiers

NCT00831207
upeclin/HC/FMB-Unesp-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

109 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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