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

NCT ID: NCT00746473

Last Updated: 2008-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2005-10-31

Brief 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.

Detailed 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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

15 HIV-1 infected individuals, with or without AIDS, who had never received ARV. These patients had not yet been indicated for ARV, or had had HIV-1 infection diagnosed a few days before inclusion in this study.

No interventions assigned to this group

2

27 HIV-1 infected individuals, sick or not, on ARV treatment, five with two nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and one nonnucleoside reverse transcriptase inhibitor (NNRTI), and 22 on HAART with two NRTI, or one NRTI and one NNRTI, and one protease inhibitor (PI), and VL equal to or greater than 50 copies of plasma RNA/mL.

Treatment duration in this group varied between three and 145 months (mean 53.62 months; median 42 months).

No interventions assigned to this group

3

31 HIV-1 infected individuals on ARV treatment, 16 on HAART with two NRTI, or one NRTI and one NNRTI, and one PI, and 15 with two NRTI and one NNRTI. All G3 patients had undetectable VL for at least the past 6 months. Treatment in this group varied between five to 108 months (mean 48.13 months; median 42 months).

No interventions assigned to this group

4

20 blood donors without clinical complaints and negative for anti-HIV-1/2 antibodies. None of them showed any sign of disease.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• HIV infection

Exclusion Criteria

• no HIV infection

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Responsible Party

Faculdade de Medicina de Botucatu - Unesp

Principal Investigators

Domingos A Meira, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina de Botucatu, Unesp

Locations

SAE e Hospital Dia de Aids

Botucatu, São Paulo, Brazil

Countries

Brazil

Other Identifiers

upeclin/HC/FMB-Unesp-12

Identifier Type: -

Identifier Source: org_study_id