Beta-2 Microglobulin and Serum Cytokines x HAART
This study has been completed.
Sponsor:
UPECLIN HC FM Botucatu Unesp
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
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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 |
|---|
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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:
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 (Adult, Senior) |
| 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
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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
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
| 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 September 26, 2016