Beta-2 Microglobulin and Serum Cytokines x HAART

Completed

• Conditions: HIV Patients

• Registration Number: NCT00831207
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

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.

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 Timeline

• Study Start: 2004-08
• Primary Completion: 2005-11
• Study Completion: 2008-12
• Study First Submitted: 2008-12-26
• Status Verified: 2009-01
• Study First Submitted QC: 2009-01-27
• Last Update Submitted: 2009-01-27
• Study First Posted: 2009-01-28
• Last Update Posted: 2009-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.	At subject enrollment.

Secondary Outcome Measures

Name	Time	Method
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.	At subject enrollment.

Trial Locations

Locations (1)

Faculdade de Medicina de Botucatu - UNESP; 🇧🇷 Botucatu, Sao Paulo, Brazil