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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 March 03, 2015