Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment

NCT02334943 | Completed DMC

• 1 other identifier: 9187
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Infection of novo persistent the day of inclusion

Secondary Outcomes (2)

• Microbial translocation

  Microbial translocation the day of inclusion

• Diagnosis immunizing activation

  Diagnosis immunizing activation the day of inclusion

Other Outcomes (4)

• No immunological response to treatment

  No immunological response to treatment the day of inclusion

• Renal Review

  Renal Review the day of inclusion

• Bone balance

  Bone balance the day of inclusion

Study Arms (3)

Treated HIV-1 infected patients

EXPERIMENTAL

Treated HIV-1 infected patients for Blood test

Biological: Blood test

No treated HIV-1 infected patients

EXPERIMENTAL

No treated HIV-1 infected patients for Blood test

Biological: Blood test

Healthy witness

EXPERIMENTAL

Healthy witness for Blood test

Biological: Blood test

Interventions

Blood test BIOLOGICAL

Blood test

Healthy witness; No treated HIV-1 infected patients; Treated HIV-1 infected patients

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 45 years
• HIV-1 infection
• Number of T CD4+ lymphocytes before antiretroviral treatment \< 350 cells/mm3
• Efficient and well tolerated antiretroviral treatment for more than 24 months
• 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

You may not qualify if:

• 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 pregnant or breastfeeding

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• JACQUES REYNES, PU PH

  Univerty Hospital Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: January 8, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

FR (1)