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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01670-43 | Other Identifier | Competent authority ANSM |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI and biopsy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of steatosis detected by MRI | Within 6 months after all patients have completed MRI |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of fibrosis or cirrhosis using non invasive markers and concordance of non invasive markers | 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 |
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Inclusion Criteria:
Age ≥40 years
Infection with HIV-1
Cumulative exposure to cART for at least 5 years and currently under cART
Viral load < 400 copies/mL
CD4 count > 100 CD4/mm3
Female may be eligible to enter and participate in the study if she:
Informed consent signed prior to any study procedure
To be covered by a medical insurance (only for French centres)
Presence of:
the metabolic syndrome as defined by the most recent international consensus definition (Alberti et al. Circulation 2009) including three components among the following criteria:
and/or clinical lipoatrophy and/or lipohypertrophy using clinical questionnaires used and validated in previous published studies (ANRS 121 Hippocampe trial),
and/or chronic elevated transaminases ≥ 1.5 ULN and / or GGT ≥ 2 ULN confirmed by two blood samples within at least three-month interval over twelve months prior screening visit.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maud LEMOINE, MD | Medical Research Council | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brussels | Brussels | Belgium | ||||
| Hôpital la Salpêtrière |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
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| 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) | 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. | 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. | 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. | 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 | Within 6 months after all patients have completed the study |
| Percentage of patients with NASH, fibrosis and cirrhosis on liver biopsy | Within 6 months after all patients have completed the study |
| Paris |
| France |
| Hôpital Saint Antoine | Paris | France |
| Medical Center for Infectious Diseases | Berlin | Germany |
| Center for HIV and Hepato-Gastroenterology | Düsseldorf | Germany |
| University Medical Center | Hamburg | Germany |
| Hannover Medical School | Hanover | Germany |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |