Skip to main content
OpenTrials
Completed

NCT Number: NCT02334943

Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood test

Biological

Blood test

Primary outcomes

  1. Infection of novo persistent

    Time frame: 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 outcomes

  1. Microbial translocation

    Time frame: Microbial translocation the day of inclusion

    Microbial translocation (DNA bacterial plasma derivative)

  2. Diagnosis immunizing activation

    Time frame: Diagnosis immunizing activation the day of inclusion

    Activation T CD4 and T CD8, B, NK

Other outcomes

  1. No immunological response to treatment

    Time frame: No immunological response to treatment the day of inclusion

    Measurement of circulating CD4 +

  2. Renal Review

    Time frame: 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

  3. Bone balance

    Time frame: Bone balance the day of inclusion

    Determination of Calcium and phosphate levels in fasting, PTH, TSH, 25hydroxy vitamin D, testosterone (male), estradiol (female)

  4. Metabolic syndrome assessment

    Time frame: Metabolic syndrome assessment the day of inclusion

    Metasting blood glucose, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.

Acronym: ACTIVIH

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.