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HIV InfectionANRS ECHAMNCT02093754

Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients

A study testing MRI and biopsy in people with HIV Infection and Liver Injuries, run by ANRS, Emerging Infectious Diseases at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will allow to assess liver related injuries in HIV patients. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
HIV Infection, Liver Injuries
What is being tested?
MRI and biopsy
Type of treatment
Surgery or procedure
How many people
460 participants
Where
7 sitesin 3 countries
Study dates
May 2014to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • 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:
  • 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.

Who cannot join

  • Coinfection with hepatitis B (positive HBs antigen or isolated positive HBc antibody with positive PCR)
  • Positive HCV serology
  • Coinfection HIV-1 and HIV-2
  • Use of intravenous drugs within the last six months
  • Excessive alcohol intake (male > 50 g/d, female > 40 g/d)
  • 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
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  • 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
  • Active opportunistic infection except for candida oesophagitis
  • Current Cancer
  • Pregnancy
  • Decompensated heart failure
  • Subject under legal guardianship
  • Inability to give informed consent or incapacitation
  • Contra-indication to MRI: pace-maker, neurovascular surgery, intraocular materials, cochlear implant, severe claustrophobia
  • Participation in another study with an ongoing exclusion period at screening

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Germany4 sites

  • Medical Center for Infectious Diseases

    Berlin

  • Center for HIV and Hepato-Gastroenterology

    Düsseldorf

  • University Medical Center

    Hamburg

  • Hannover Medical School

    Hanover

Other trials in Germany

France2 sites

  • Hôpital la Salpêtrière

    Paris

  • Hôpital Saint Antoine

    Paris

Other trials in France

Belgium1 site

  • CHU Brussels

    Brussels

Other trials in Belgium

About this study

Official title: 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.

Read the detailed description

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
Being tested
MRI and biopsy
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI and biopsyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of steatosis detected by MRI

    Measured: Within 6 months after all patients have completed MRI

Secondary outcomes (8)

  1. Percentage of fibrosis or cirrhosis using non invasive markers and concordance of non invasive markers

    Measured: Within 6 months after all patients have completed the study

  2. Risk factors (age, duration of infection, treatment, clinical and biological metabolic and adipose tissue parameters) of liver injuries

    Measured: Within 6 months after all patients have completed the study

  3. Independent risk factors of NAFLD, NASH and fibrosis (including markers of insulin resistance, inflammatory cytokines, markers of immune activation, adipokines)

    Measured: Within 6 months after all patients have completed the study

  4. 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.

    Measured: Within 6 months after all patients have completed the study

  5. 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.

    Measured: Within 6 months after all patients have completed the study

  6. 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.

    Measured: Within 6 months after all patients have completed the study

  7. Impact of IL28B and PNPLA3 genetic polymorphisms on the severity of liver steatosis, inflammation and fibrosis

    Measured: Within 6 months after all patients have completed the study

  8. Percentage of patients with NASH, fibrosis and cirrhosis on liver biopsy

    Measured: Within 6 months after all patients have completed the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02093754
Sponsor's protocol ID
ECHAM
Other IDs
2012-A01670-43
Acronym
ANRS ECHAM
Status last verified
Jul 2016
First submitted
17 Jan 2014
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing MRI and biopsy in people with HIV Infection and Liver Injuries, run by ANRS, Emerging Infectious Diseases at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of steatosis detected by MRI (time frame: Within 6 months after all patients have completed MRI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02093754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.

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