Beta-2 Microglobulin and Serum Cytokines x HAART

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00831207

Enrollment

109

Registered

2009-01-28

Start date

2004-08-31

Completion date

2008-12-31

Last updated

2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Patients

Keywords

B-2 microglobulin, Serum cytokines, HIV-1, Resistance, HAART, Therapeutic failure, Genotyping.

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.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.

Countries

Brazil

Outcome results