Beta-2 Microglobulin and Serum Cytokines x HAART

HIV Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831207
• Other study ID #: upeclin/HC/FMB-Unesp-19
• Status: Completed
• Phase: N/A
• First received: December 26, 2008
• Last updated: January 27, 2009
• Start date: August 2004
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2008
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Patients

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Botucatu - UNESP	Botucatu	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.		At subject enrollment.	No
Secondary	To assess the behavior of serum cytokines TNF-a, IFN-?, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.		At subject enrollment.	No