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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

Tracking Information
First Submitted Date  ICMJE July 22, 2014
First Posted Date  ICMJE January 8, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 6, 2015)
  • No immunological response to treatment [ Time Frame: No immunological response to treatment the day of inclusion ]
    Measurement of circulating CD4 +
  • 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
  • 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)
  • Metabolic syndrome assessment [ Time Frame: Metabolic syndrome assessment the day of inclusion ]
    Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment
Official Title  ICMJE Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Immune Deficiency
  • HIV-related Gut Disease - Cause Unknown
  • Activation of Latent Virus
  • Other Diagnoses, Comorbidities, and Complications
Intervention  ICMJE Biological: Blood test
Blood test
Study Arms  ICMJE
  • Experimental: Treated HIV-1 infected patients
    Treated HIV-1 infected patients for Blood test
    Intervention: Biological: Blood test
  • Experimental: No treated HIV-1 infected patients
    No treated HIV-1 infected patients for Blood test
    Intervention: Biological: Blood test
  • Experimental: Healthy witness
    Healthy witness for Blood test
    Intervention: Biological: Blood test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2015)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02334943
Other Study ID Numbers  ICMJE 9187
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JACQUES REYNES, PU PH Univerty Hospital Montpellier
PRS Account University Hospital, Montpellier
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP