NCT02353767

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

January 29, 2015

Last Update Submit

February 2, 2015

Conditions

Abdominal Obesity Metabolic SyndromeHIVLiver Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Liver fibrosis

    Liver fibrosis as measured by Fibroscanner

    One time

Secondary Outcomes (2)

  • Liver steatosis

    One time

  • Hand osteoarthritis

    One time

Study Arms (2)

Cases

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

Procedure: Noninvasive evaluation of liver fibrosis and steatosis

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

Interventions

Noninvasive evaluation of liver fibrosis and steatosisPROCEDURE

Transient elastography (using the Fibroscan, CAP Fibroscan) and biomarker panels (FibroTest, Fibromètre, Hepascore, Steatotest, Nashtest)

CasesControls

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients followed in the Infectious Diseases department of Saint-Antoine hospital.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Lewden C, May T, Rosenthal E, Burty C, Bonnet F, Costagliola D, Jougla E, Semaille C, Morlat P, Salmon D, Cacoub P, Chene G; ANRS EN19 Mortalite Study Group and Mortavic1. Changes in causes of death among adults infected by HIV between 2000 and 2005: The "Mortalite 2000 and 2005" surveys (ANRS EN19 and Mortavic). J Acquir Immune Defic Syndr. 2008 Aug 15;48(5):590-8. doi: 10.1097/QAI.0b013e31817efb54.

    PMID: 18645512BACKGROUND

  • Worm SW, Friis-Moller N, Bruyand M, D'Arminio Monforte A, Rickenbach M, Reiss P, El-Sadr W, Phillips A, Lundgren J, Sabin C; D:A:D study group. High prevalence of the metabolic syndrome in HIV-infected patients: impact of different definitions of the metabolic syndrome. AIDS. 2010 Jan 28;24(3):427-35. doi: 10.1097/QAD.0b013e328334344e.

    PMID: 19910787BACKGROUND

  • Fonquernie F, Lacombe K, Vincensini JP, Boccara F, Clozel S, Ayouch Boda A, Bollens D, Campa P, Pacanowski J, Meynard JL, Meyohas MC, Girard PM. How to improve the quality of a disease management program for HIV-infected patients using a computerized data system. The Saint-Antoine Orchestra program. AIDS Care. 2010 May;22(5):588-96. doi: 10.1080/09540120903280893.

    PMID: 20401768BACKGROUND

  • Tomi AL, Sellam J, Lacombe K, Fellahi S, Sebire M, Rey-Jouvin C, Miquel A, Bastard JP, Maheu E, Haugen IK, Felson DT, Capeau J, Girard PM, Berenbaum F, Meynard JL. Increased prevalence and severity of radiographic hand osteoarthritis in patients with HIV-1 infection associated with metabolic syndrome: data from the cross-sectional METAFIB-OA study. Ann Rheum Dis. 2016 Dec;75(12):2101-2107. doi: 10.1136/annrheumdis-2016-209262. Epub 2016 Mar 31.

    PMID: 27034453DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum

MeSH Terms

Conditions

Abdominal obesity metabolic syndromeLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 3, 2015

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 3, 2015

Record last verified: 2015-01