Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment

Overview

Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome).

Full Title of Study: “Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Detailed Description

Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome). These correlations could highlight physiopathologic mechanisms relating a specific cause of immune activation, activation of a specific subpopulation of immune cells and a comorbidity. Physiopathologic mechanisms could then be tested in vitro and lead into new therapeutic tracks of immune activation secondary to HIV-1 or to the natural ageing process.

Interventions

  • Biological: Blood test
    • Blood test

Arms, Groups and Cohorts

  • Experimental: Treated HIV-1 infected patients
    • Treated HIV-1 infected patients for Blood test
  • Experimental: No treated HIV-1 infected patients
    • No treated HIV-1 infected patients for Blood test
  • Experimental: Healthy witness
    • Healthy witness for Blood test

Clinical Trial Outcome Measures

Primary Measures

  • Infection of novo persistent
    • Time Frame: Infection of novo persistent the day of inclusion
    • Etiologic factors of persistent immune activation in treated HIV-1 infected patients (obstinacy of the infection of new cells T CD4 +, microbial translocation, active coinfection, immunosenescence, lymphopenia T CD4 +, deficit in lymphocytes Treg) on a day: the day of the inclusion

Secondary Measures

  • Microbial translocation
    • Time Frame: Microbial translocation the day of inclusion
    • Microbial translocation (DNA bacterial plasma derivative)
  • Diagnosis immunizing activation
    • Time Frame: Diagnosis immunizing activation the day of inclusion
    • Activation T CD4 and T CD8, B, NK

Participating in This Clinical Trial

Inclusion Criteria

  • Age > or = 45 years – HIV-1 infection – Number of T CD4+ lymphocytes before antiretroviral treatment < 350 cells/mm3 – Current number of T CD4+ lymphocytes > 200 cells / mm3 for 6 moths before inclusion – Efficient and well tolerated antiretroviral treatment for more than 24 months – HIV-1 viral load < 50 copies/ml for more than 24 months before inclusion – Patient able to understand the nature, the objective and the methods of the study – Patient having signed the informed consent – Affiliation to French Social Security System Exclusion criteria:

  • Patient having a current evidence of II to IV rank of the ANRS scale clinical condition – Patient having a current evidence of III to IV rank of the ANRS scale biological condition – Patient has a current evidence of an active coinfection – Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests and undetectable viral load of hepatitis B and/or C – Patient has a cirrhosis – Patient presents with a non infectious pathology that might give immune modifications – Patient using immuno-modulator therapy or chemotherapy – Patient is currently participating or has participated in a study (within the exclusion period defined by this study) – Patient is pregnant or breastfeeding

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • JACQUES REYNES, PU PH, Principal Investigator, Univerty Hospital Montpellier

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