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Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients (ANRS ECHAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT02093754
First received: January 17, 2014
Last updated: June 2, 2014
Last verified: June 2014

January 17, 2014
June 2, 2014
May 2014
December 2016   (final data collection date for primary outcome measure)
Percentage of steatosis detected by MRI [ Time Frame: Within 6 months after all patients have completed MRI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02093754 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Autophagosome formation in the liver biopsis (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of patients with NASH, fibrosis and cirrhosis on liver biopsy [ Time Frame: Within 6 months after all patients have completed the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients
Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients: a European Multicentre Study

This study will allow to assess liver related injuries in HIV patients.

This study is a cross-sectional, multicentre study including 8 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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV Infection
  • Liver Injuries
Procedure: MRI and biopsy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age ≥40 years
  2. Infection with HIV-1
  3. Cumulative exposure to cART for at least 5 years and currently under cART
  4. Viral load < 400 copies/mL
  5. CD4 count > 100 CD4/mm3
  6. Female may be eligible to enter and participate in the study if she:

    • is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
    • is of child-bearing potential with a negative blood pregnancy test at screening visit
  7. Informed consent signed prior to any study procedure
  8. To be covered by a medical insurance (only for French centres)
  9. 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:

      • visceral obesity (waist circumference: Europeans and Africans ≥ 94 cm for men and ≥ 80 cm for women, Americans ≥ 102 cm for men and ≥ 88 cm for women, Asians ≥ 90 cm for men and ≥ 80 cm for women)
      • blood glucose ≥ 1 g/L (5,6 mmol/L) or anti-diabetic treatment,
      • serum triglycerides ≥ 1,5 g/L (1,7 mmol/L) or hypertriglycerides treatment,
      • serum HDL cholesterol < 0,4 g/L (1 mmol/L) for men and < 0,5 g/L (1,3 mmol/L) for women or hypercholesterolemia treatment,
      • blood pressure (Diastolic ≥130 mmHg and/or Systolic ≥ 85 mmHg) or antihypertensive treatment
    • 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:

  1. Coinfection with hepatitis B (positive HBs antigen or isolated positive HBc antibody with positive PCR)
  2. Positive HCV serology
  3. Coinfection HIV-1 and HIV-2
  4. Use of intravenous drugs within the last six months
  5. Excessive alcohol intake (male > 50 g/d, female > 40 g/d)
  6. Other causes of liver diseases i.e: viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary or secondary biliary cirrhosis, primary or secondary cholangitis, α1 antitrypsine deficiency
  7. Other causes of liver steatosis: current steroid therapy, current therapy with amiodarone, tamoxifen, methotrexate, nifedipine, or hycanthone; history of cancer chemotherapy; short bowel syndrome, polycystic ovarian syndrome, Weber-Christian disease
  8. Active opportunistic infection except for candida oesophagitis
  9. Current Cancer
  10. Pregnancy
  11. Decompensated heart failure
  12. Subject under legal guardianship
  13. Inability to give informed consent or incapacitation
  14. Contra-indication to MRI: pace-maker, neurovascular surgery, intraocular materials, cochlear implant, severe claustrophobia
  15. Participation in another study with an ongoing exclusion period at screening
Both
40 Years and older
No
Contact: MAUD LEMOINE, MD m.lemoine@imperial.ac.uk
Belgium,   France,   Germany
 
NCT02093754
ECHAM, 2012-A01670-43
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Principal Investigator: Maud LEMOINE, MD Medical Research Council
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP