Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment

Immune Deficiency Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334943
• Other study ID #: 9187
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: November 19, 2015
• Start date: March 2015
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Activation of Latent Virus
• HIV-related Gut Disease - Cause Unknown
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Other Diagnoses, Comorbidities, and Complications

Intervention

Biological:
• Blood test
Blood test

Locations

Country	Name	City	State
France	University hospital Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	No immunological response to treatment	Measurement of circulating CD4 +	No immunological response to treatment the day of inclusion	No
Other	Renal Review	Estimated glomerular filtration rate, Na / K / Cl / alkaline reserve, blood uric acid, typing with proteinuria, albuminuria, creatinine, phosphorus reabsorption, urine dipstick	Renal Review the day of inclusion	No
Other	Bone balance	Determination of Calcium and phosphate levels in fasting, PTH, TSH, 25hydroxy vitamin D, testosterone (male), estradiol (female)	Bone balance the day of inclusion	No
Other	Metabolic syndrome assessment	Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol	Metabolic syndrome assessment the day of inclusion	No
Primary	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	No
Secondary	Microbial translocation	Microbial translocation (DNA bacterial plasma derivative)	Microbial translocation the day of inclusion	No
Secondary	Diagnosis immunizing activation	Activation T CD4 and T CD8, B, NK	Diagnosis immunizing activation the day of inclusion	No