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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT02334943

Collaborator

(none)

140

Enrollment

Location

Arms

Study Details

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).

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	N/A

Detailed Description

Study Design

Study Type:

Interventional

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 :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Infection of novo persistent [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

Microbial translocation [Microbial translocation the day of inclusion]
Microbial translocation (DNA bacterial plasma derivative)
Diagnosis immunizing activation [Diagnosis immunizing activation the day of inclusion]
Activation T CD4 and T CD8, B, NK

Other Outcome Measures

No immunological response to treatment [No immunological response to treatment the day of inclusion]
Measurement of circulating CD4 +
Renal Review [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 [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 [Metabolic syndrome assessment the day of inclusion]
Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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