Beta-2 Microglobulin and Serum Cytokines x HAART
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ClinicalTrials.gov Identifier: NCT00831207 |
Recruitment Status
:
Completed
First Posted
: January 28, 2009
Last Update Posted
: January 28, 2009
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Condition or disease |
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HIV Patients |
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.
Study Type : | Observational |
Actual Enrollment : | 109 participants |
Time Perspective: | Cross-Sectional |
Official Title: | Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | December 2008 |

Group/Cohort |
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G1
15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3.
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G2
31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF).
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G3
43 HIV-1+ individuals undergoing HAART with TF.
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G4
20 normal individuals who served as controls for serum cytokines.
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- To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure. [ Time Frame: At subject enrollment. ]
- 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. ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831207
Brazil | |
Faculdade de Medicina de Botucatu - UNESP | |
Botucatu, Sao Paulo, Brazil, 18618-970 |
Principal Investigator: | Ricardo MB Almeida, MSc | Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP. |
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 |
First Posted: | January 28, 2009 Key Record Dates |
Last Update Posted: | January 28, 2009 |
Last Verified: | January 2009 |
Keywords provided by UPECLIN HC FM Botucatu Unesp:
B-2 microglobulin Serum cytokines HIV-1 Resistance |
HAART Therapeutic failure Genotyping. |