Activation of Latent Virus, HIV-related Gut Disease - Cause Unknown, Immune Deficiency, Other Diagnoses, Comorbidities, and Complications
Conditions
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
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.
Interventions
BIOLOGICALBlood test
Blood test
Sponsors
University Hospital, Montpellier
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| No immunological response to treatment | No immunological response to treatment the day of inclusion | Measurement of circulating CD4 + |
| Metabolic syndrome assessment | Metabolic syndrome assessment the day of inclusion | Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol |
| 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) |
Countries
France
Outcome results
None listed