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Completed

NCT Number: NCT00831207

Beta-2 Microglobulin and Serum Cytokines x HAART

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.

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Key information

Conditions

HIV Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, 18618-970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.

    Time frame: At subject enrollment.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Collaborators

  • Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Registry information

Official study title

Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Jan 28, 2009
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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