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

Primary Purpose

Immune Deficiency, HIV-related Gut Disease - Cause Unknown, Activation of Latent Virus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Immune Deficiency focused on measuring 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

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University hospital Montpellier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treated HIV-1 infected patients

No treated HIV-1 infected patients

Healthy witness

Arm Description

Treated HIV-1 infected patients for Blood test

No treated HIV-1 infected patients for Blood test

Healthy witness for Blood test

Outcomes

Primary Outcome Measures

Infection of novo persistent
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

Microbial translocation
Microbial translocation (DNA bacterial plasma derivative)
Diagnosis immunizing activation
Activation T CD4 and T CD8, B, NK

Full Information

First Posted
July 22, 2014
Last Updated
November 19, 2015
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02334943
Brief Title
Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment
Acronym
ACTIVIH
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Deficiency, HIV-related Gut Disease - Cause Unknown, Activation of Latent Virus, Other Diagnoses, Comorbidities, and Complications
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated HIV-1 infected patients
Arm Type
Experimental
Arm Description
Treated HIV-1 infected patients for Blood test
Arm Title
No treated HIV-1 infected patients
Arm Type
Experimental
Arm Description
No treated HIV-1 infected patients for Blood test
Arm Title
Healthy witness
Arm Type
Experimental
Arm Description
Healthy witness for Blood test
Intervention Type
Biological
Intervention Name(s)
Blood test
Intervention Description
Blood test
Primary Outcome Measure Information:
Title
Infection of novo persistent
Description
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
Time Frame
Infection of novo persistent the day of inclusion
Secondary Outcome Measure Information:
Title
Microbial translocation
Description
Microbial translocation (DNA bacterial plasma derivative)
Time Frame
Microbial translocation the day of inclusion
Title
Diagnosis immunizing activation
Description
Activation T CD4 and T CD8, B, NK
Time Frame
Diagnosis immunizing activation the day of inclusion
Other Pre-specified Outcome Measures:
Title
No immunological response to treatment
Description
Measurement of circulating CD4 +
Time Frame
No immunological response to treatment the day of inclusion
Title
Renal Review
Description
Estimated glomerular filtration rate, Na / K / Cl / alkaline reserve, blood uric acid, typing with proteinuria, albuminuria, creatinine, phosphorus reabsorption, urine dipstick
Time Frame
Renal Review the day of inclusion
Title
Bone balance
Description
Determination of Calcium and phosphate levels in fasting, PTH, TSH, 25hydroxy vitamin D, testosterone (male), estradiol (female)
Time Frame
Bone balance the day of inclusion
Title
Metabolic syndrome assessment
Description
Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol
Time Frame
Metabolic syndrome assessment the day of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JACQUES REYNES, PU PH
Organizational Affiliation
Univerty Hospital Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment

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