Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients (ANRS ECHAM)
|ClinicalTrials.gov Identifier: NCT02093754|
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Liver Injuries||Procedure: MRI and biopsy||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||460 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients: a European Multicentre Study|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
- 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) [ Time Frame: Within 6 months after all patients have completed the study ]Quantifiable levels of serum adiponectin, serum leptin, serum HS-IL-6, HS-CRP, serum s-CD14 will be measured.
- Description of pathogenetic factors and correlates with autophagy in liver biopsies of patients with evidence for liver fibrosis [ Time Frame: Within 6 months after all patients have completed the study ]Autophagosome formation in the liver biopsies (only for patients presenting liver fibrosis equal or > 2 will be quantified.
- 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) [ Time Frame: Within 6 months after all patients have completed the study ]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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093754
|Hôpital la Salpêtrière|
|Hôpital Saint Antoine|
|Medical Center for Infectious Diseases|
|Center for HIV and Hepato-Gastroenterology|
|University Medical Center|
|Hannover Medical School|
|Principal Investigator:||Maud LEMOINE, MD||Medical Research Council|