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Beta-2 Microglobulin and Serum Cytokines x HAART

This study has been completed.
Sponsor:
Collaborator:
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00831207
First received: December 26, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition
HIV Patients

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure. [ Time Frame: At subject enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: At subject enrollment. ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: August 2004
Study Completion Date: December 2008
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
G4
20 normal individuals who served as controls for serum cytokines.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831207

Locations
Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, Sao Paulo, Brazil, 18618-970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Investigators
Principal Investigator: Ricardo MB Almeida, MSc Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.
  More Information

No publications provided

Responsible Party: Ricardo Augusto Monteiro de Barros Almeida, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
ClinicalTrials.gov Identifier: NCT00831207     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-19
Study First Received: December 26, 2008
Last Updated: January 27, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
B-2 microglobulin
Serum cytokines
HIV-1
Resistance
 HAART
Therapeutic failure
Genotyping.

ClinicalTrials.gov processed this record on May 16, 2013