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

NCT00746473 | Completed DMC

• 1 other identifier: upeclin/HC/FMB-Unesp-12
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Study Arms (4)

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.

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).

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).

4

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

Eligibility Criteria

• Age: 22 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All 73 HIV-1 infected individuals were submitted to full clinical observation including associated opportunistic diseases at time of blood collection for cytokine detection.

You may qualify if:

• HIV infection

You may not qualify if:

• no HIV infection

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

SAE e Hospital Dia de Aids

Botucatu, São Paulo, Brazil

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Domingos A Meira, PhD, MD

  Faculdade de Medicina de Botucatu, Unesp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2004
• Study Completion: October 1, 2005
• Last Updated: September 4, 2008

Record last verified: 2008-09

Locations

BR (1)