Beta-2 Microglobulin and Serum Cytokines x HAART

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-12-31

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.

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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.

Conditions

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HIV Patients

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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G1

15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ \< 350 cells/mm3.

No interventions assigned to this group

G2

31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF).

No interventions assigned to this group

G3

43 HIV-1+ individuals undergoing HAART with TF.

No interventions assigned to this group

G4

20 normal individuals who served as controls for serum cytokines.

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes