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Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment (ACTIVIH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334943
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Immune Deficiency HIV-related Gut Disease - Cause Unknown Activation of Latent Virus Other Diagnoses, Comorbidities, and Complications Biological: Blood test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.
Study Start Date : March 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Treated HIV-1 infected patients
Treated HIV-1 infected patients for Blood test
Biological: Blood test
Blood test

Experimental: No treated HIV-1 infected patients
No treated HIV-1 infected patients for Blood test
Biological: Blood test
Blood test

Experimental: Healthy witness
Healthy witness for Blood test
Biological: Blood test
Blood test




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Microbial translocation [ Time Frame: Microbial translocation the day of inclusion ]
    Microbial translocation (DNA bacterial plasma derivative)

  2. Diagnosis immunizing activation [ Time Frame: Diagnosis immunizing activation the day of inclusion ]
    Activation T CD4 and T CD8, B, NK


Other Outcome Measures:
  1. No immunological response to treatment [ Time Frame: No immunological response to treatment the day of inclusion ]
    Measurement of circulating CD4 +

  2. Renal Review [ Time Frame: Renal Review the day of inclusion ]
    Estimated glomerular filtration rate, Na / K / Cl / alkaline reserve, blood uric acid, typing with proteinuria, albuminuria, creatinine, phosphorus reabsorption, urine dipstick

  3. Bone balance [ Time Frame: Bone balance the day of inclusion ]
    Determination of Calcium and phosphate levels in fasting, PTH, TSH, 25hydroxy vitamin D, testosterone (male), estradiol (female)

  4. Metabolic syndrome assessment [ Time Frame: Metabolic syndrome assessment the day of inclusion ]
    Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334943


Locations
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France
University hospital Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: JACQUES REYNES, PU PH Univerty Hospital Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02334943    
Other Study ID Numbers: 9187
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by University Hospital, Montpellier:
Immune Activation
HIV-1 infected subjects
Undetectable viral load
Causes of Immune Activation in HIV-1 infected patients
Forms of Immune Activation
Emergent non-AIDS related comorbidities
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases