This study will allow to assess liver related injuries in HIV patients.
This study is a cross-sectional, multicentre study including 7 centres from 3 European countries (Belgium, France, Germany). The maximum duration of the study for each patient will be 4 months, consisting of: * a screening visit, * an inclusion visit to perform the biologic tests and exams necessary for the study, within 1 month after the screening visit, * a result delivery visit within 1 month after inclusion visit, to disclose results of previous investigations. Patients with one or two non invasive markers suggesting significant fibrosis (≥F2) will be invited for liver biopsy within the next 2 months. * a "liver biopsy" visit, within 2 months after visit 2, liver biopsy in selected and consented patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
460
CHU Brussels
Brussels, Belgium
Hôpital la Salpêtrière
Paris, France
Hôpital Saint Antoine
Paris, France
Medical Center for Infectious Diseases
Berlin, Germany
Percentage of steatosis detected by MRI
Time frame: Within 6 months after all patients have completed MRI
Percentage of fibrosis or cirrhosis using non invasive markers and concordance of non invasive markers
Time frame: Within 6 months after all patients have completed the study
Risk factors (age, duration of infection, treatment, clinical and biological metabolic and adipose tissue parameters) of liver injuries
Time frame: Within 6 months after all patients have completed the study
Independent risk factors of NAFLD, NASH and fibrosis (including markers of insulin resistance, inflammatory cytokines, markers of immune activation, adipokines)
Time frame: Within 6 months after all patients have completed the study
Establish a diagnosis score based on biomarkers of liver injuries (Adiponectin, leptin, IL6, CRP, CD14)
Quantifiable levels of serum adiponectin, serum leptin, serum HS-IL-6, HS-CRP, serum s-CD14 will be measured.
Time frame: Within 6 months after all patients have completed the study
Description of pathogenetic factors and correlates with autophagy in liver biopsies of patients with evidence for liver fibrosis
Autophagosome formation in the liver biopsies (only for patients presenting liver fibrosis equal or \> 2 will be quantified.
Time frame: Within 6 months after all patients have completed the study
Identification of features of the adaptive immune system associated to NAFLD, NASH and fibrosis (T cell activation, surface expression of Treg, NK cells, NKT cells)
Quantifiable levels of T cell activation (in PBMC), Frequency and phenotype of Tregs (in PBMC), Quantifiable levels of NK cells (in PBMC), Quantifiable levels of Th17 and γδ T cell (in PBMC), Quantifiable levels of Plasma LPS and LPB (sCD163, CD26, Cytokeratin 18) will be measured.
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Center for HIV and Hepato-Gastroenterology
Düsseldorf, Germany
University Medical Center
Hamburg, Germany
Hannover Medical School
Hanover, Germany
Time frame: Within 6 months after all patients have completed the study
Impact of IL28B and PNPLA3 genetic polymorphisms on the severity of liver steatosis, inflammation and fibrosis
Time frame: Within 6 months after all patients have completed the study
Percentage of patients with NASH, fibrosis and cirrhosis on liver biopsy
Time frame: Within 6 months after all patients have completed the study