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Evaluation of Liver Fibrosis in HIV-infected Patients With Metabolic Syndrome (METAFIB)

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ClinicalTrials.gov Identifier: NCT02353767
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Brief Summary:
This study aims to estimate the prevalence of bridging liver fibrosis and cirrhosis (METAVIR score ≥ F2) according to METAVIR score in HIV infected patients not chronically infected by viral hepatitis but exhibiting a metabolic syndrome according to the IDF definition (International Diabetes Foundation).

Condition or disease Intervention/treatment
Abdominal Obesity Metabolic Syndrome HIV Liver Fibrosis Procedure: Noninvasive evaluation of liver fibrosis and steatosis

Detailed Description:

HIV-associated morbidity and mortality has been considerably modified ever since the availability of potent antiretroviral treatment in 1996. Recent studies have shown the impact of treatment, with the decreased frequency of AIDS-related diseases coinciding with the preponderance of non-AIDS related pathologies.

Consequently, diseases of hepatic origin have become a key problem in the therapeutic course of HIV-infected patients, representing a major source of significant morbidity and mortality. Liver-related diseases comprise of various etiologies, including co-infection with chronic viral hepatitis and excessive alcohol consumption. When excluding these particular diseases, fibrotic patients exhibit an elevated prevalence of metabolic syndrome, regardless of lipodystrophy. Directly linked to metabolic syndrome, non-alcoholic hepatic steatosis has the capacity to induce necro-inflammatory lesions with an increased risk of evolving into cirrhosis and its complications thereto (i.e. hepatocellular carcinoma, liver decompensation, and end-stage liver disease). In the context of HIV, very little data is available concerning the link between metabolic syndrome and hepatic fibrosis, despite the increasing risk of developing such disease during extended life-span, the long-term disruption of glycolipid metabolism induced by antiretroviral treatment, and the presence of various social risk-factors (i.e. increasing trends in weight gain and decreased physical activity).

The principal objective of the present study is to then characterize the prevalence and determinants associated with hepatic fibrosis among HIV-infected patients, without co-infection with other hepatitis viruses, and who present symptoms of metabolic syndrome according to the AHA 2009 definition. In order to more appropriately answer this research question, we will conduct a nested, matched case-control study including 300 HIV-infected patients per group. We will also aim to identify risk-factors of liver fibrosis other than metabolic syndrome, to study agreement in 4 non-invasive scores of liver fibrosis and 3 non-invasive score of steatosis, and to evaluate the performance of the Controlled Attenuation Parameter (CAP) method for use in diagnosing hepatic steatosis.

All patients in this study will be recruited in a clinical center situated in the infectious disease unit at Saint-Antoine Hospital, where 3400 HIV-infected patients have regular consultations. Patients will be identified from an in-house informatics platform, serving as a surveillance tool for metabolic syndrome, among other diseases, with the intention of increasing better-adapted clinical and therapeutic care. Each patient presenting with metabolic syndrome will be matched with a control patient on the following characteristics: age (±5 years), duration of HIV-infection (±2 years), HIV-RNA viral load (in categories of <50-500, 501-1000, or >1000 copies/mL), and gender. Patients with abnormal transaminases will be excluded from this study.

This study will bring about a clearer understanding of the frequency and importance of liver fibrosis risk in patients with metabolic syndrome, which will allow us to determine the more important elements of surveillance necessary in the prevention and development of hepatic lesions. Accordingly, this study will add more pertinent information regarding treatment guidelines specific to this patient population.

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Study Type : Observational
Actual Enrollment : 478 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : January 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
Presence of metabolic syndrome according to the International Diabetes Foundation (IDF)
Procedure: Noninvasive evaluation of liver fibrosis and steatosis
Transient elastography (using the Fibroscan, CAP Fibroscan) and biomarker panels (FibroTest, Fibromètre, Hepascore, Steatotest, Nashtest)

Controls
  • age ± 7 years from cases
  • duration of HIV-1 infection ± 3 years from cases
  • HIV-1 viral load matched to cases according to 3 thresholds: 50 - 500, 501 - 1000 or > 1000 copies/mL
Procedure: Noninvasive evaluation of liver fibrosis and steatosis
Transient elastography (using the Fibroscan, CAP Fibroscan) and biomarker panels (FibroTest, Fibromètre, Hepascore, Steatotest, Nashtest)




Primary Outcome Measures :
  1. Liver fibrosis [ Time Frame: One time ]
    Liver fibrosis as measured by Fibroscanner


Secondary Outcome Measures :
  1. Liver steatosis [ Time Frame: One time ]
    Sub group of patients who had IRM measurements

  2. Hand osteoarthritis [ Time Frame: One time ]
    Sub group of patients who had an X-Ray of their hands


Biospecimen Retention:   Samples Without DNA
plasma, serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients followed in the Infectious Diseases department of Saint-Antoine hospital.
Criteria

Inclusion Criteria:

A. For all patients:

  • >18 years of age
  • HIV-1 infection for a minimum of 5 years confirmed by Western Blot or ELISA
  • Signed and full comprehension of informed consent
  • Affiliation to Sécurité Sociale

B. Specific to Cases :

Presence of metabolic syndrome according to the International Diabetes Foundation (IDF)

C. Matched Criteria specific to controls :

  • Same age ± 7 years
  • Same duration of HIV-1 infection ± 3 years
  • Same criterion of HIV-1 viral load (according to 3 thresholds: 50 - 500, 501 - 1000 or > 1000 c/mL)

Exclusion Criteria:

  • Chronic hepatitis B (HBs-Ag positive or isolated positive antiHBc-Ab with positive HBV-DNA)
  • Chronic hepatitis C (positive antiHCV-Ab)
  • Active IV or oral drug use and/or ongoing substitution therapy
  • Other known chronic hepatitis : auto-immune hepatitis, primary or secondary biliary cirrhosis, hemochromatosis, Wilson disease, alpha 1 anti-trypsin deficit, primary or secondary sclerosing cholangitis, biliary obstruction, liver vascular disease associated with HIV infection, biliary or liver cancer
  • CD4 < 50/mm3
  • Any current opportunistic infection
  • Serious condition influencing vital status
  • Pregnancy
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT02353767    
Other Study ID Numbers: IMEA 42
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Liver Cirrhosis
Metabolic Syndrome
Obesity, Abdominal
Syndrome
Fibrosis
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Obesity
Overnutrition
Nutrition Disorders