Clinical trial NCT00831207: Beta-2 Microglobulin and Serum Cytokines x HAART
Official title: Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Patients
Keywords: B-2 microglobulin
Serum cytokines
HIV-1
Resistance
HAART
Therapeutic failure
Genotyping.
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
First posted: 2009-01-28
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 89 HIV-1-infected individuals assisted by the Tropical Diseases Sector of the Botucatu School of Medicine - UNESP and 20 normal blood donors at the Botucatu Blood Bank.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.
timeFrame: At subject enrollment.
Secondary outcomes:
measure: 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.
timeFrame: At subject enrollment.
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - UNESP
state: Sao Paulo
Study officials:
affiliation: Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.
name: Ricardo MB Almeida, MSc
role: PRINCIPAL_INVESTIGATOR
References: