Assessment of Cytokine Values in Serum and by RT-PCR in HIV-1 Individuals With and Without HAART

HIV Infections Clinical Trial

Official title:

Assessment of Cytokine Values in Serum and by Specific cDNA Amplification and Detection Using RT-PCR in HIV-1 Infected Individuals With and Without Highly Active Anti-Retroviral Therapy (HAART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746473
• Other study ID #: upeclin/HC/FMB-Unesp-12
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: September 3, 2008
• Start date: August 2004
• Est. completion date: October 2005

Study information

• Verified date: September 2008
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (>80% - r2>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups.

Description:

A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment (ARV) at the AIDS Day-Hospital, Botucatu School of Medicine, Unesp. Between August 2004 and October 2005, 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (>80% - r2>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups. Several authors have recently drawn attention to the substantial apoptosis of infected and non infected CD4+T cells, mainly during primary infection, persisting only in those with INF-g phenotype producer and not IL-2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 66 Years

Eligibility

Inclusion Criteria:

• HIV infection

Exclusion Criteria:

• no HIV infection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Brazil	SAE e Hospital Dia de Aids	Botucatu	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil,