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Beta-2 Microglobulin and Serum Cytokines x HAART
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Purpose
| 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 |
- 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. ]
| 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 (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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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. |
More Information
| 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 |
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 September 21, 2017