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

Tracking Information

First Received Date ^ICMJE

December 26, 2008

Last Updated Date

January 27, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00831207 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Beta-2 Microglobulin and Serum Cytokines x HAART

Official Title ^ICMJE

Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure

Brief Summary

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

HIV Patients

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

109

Completion Date

December 2008

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00831207

Other Study ID Numbers ^ICMJE

upeclin/HC/FMB-Unesp-19

Has Data Monitoring Committee

Yes

Responsible Party

Ricardo Augusto Monteiro de Barros Almeida, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Study Sponsor ^ICMJE

UPECLIN HC FM Botucatu Unesp

Collaborators ^ICMJE

Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Investigators ^ICMJE

Principal Investigator:

Ricardo MB Almeida, MSc

Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.

Information Provided By

UPECLIN HC FM Botucatu Unesp

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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