Beta-2 Microglobulin and Serum Cytokines x HAART

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Patients

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-2 microglobulin, Serum cytokines, HIV-1, Resistance, HAART, Therapeutic failure, Genotyping.