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Prevalence of Advanced Fibrosis in Patients Living With HIV (FLASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04066608
Recruitment Status : Enrolling by invitation
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Information provided by (Responsible Party):
Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz

Brief Summary:
Monocentric, cross-sectional study to define the prevalence of advanced fibrosis in an HIV infected outpatient population

Condition or disease
Fatty Liver Disease

Detailed Description:
Globally a shift in the spectrum of diseases has occurred. While in earlier year's infectious (communicable) disease were the main contributors to morbidity and mortality, today non-communicable diseases (NCD) exhibit a dramatic increase and have reached epidemic proportions, even in developing countries. Diabetes, cardiovascular disease, and cancer are the most frequent NCDs and the underlying risk factors including Insulin resistance, dyslipidemia and obesity have been increasing over the last decades. The current study explores the prevalence of advanced fibrosis in an HIV-infected outpatient study population.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cross-sectional Study on the Prevalence of Fatty Liver and Metabolic Risk Factors in an HIV-infected Population
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Primary Outcome Measures :
  1. Advanced hepatic fibrosis defined by transient elastography using Fibroscan and a cut-off value of >8,6 kPa [ Time Frame: 24 months ]
    250 patients will be assessed by transient elastography using fibroscan

Secondary Outcome Measures :
  1. Prevalence of hepatic steatosis [ Time Frame: 24 months ]
    The secondary outcome measure is the prevelance of hepatic steatosis assessed by controlled attenuation parameter (CAP) using Fibroscan with a threshold defined with 248 db/m

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient Study Population at the University Medical Center Mainz

Inclusion Criteria:

  • informed consent
  • age >18

Exclusion Criteria:

  • pregnancy
  • disease with expectation of life under 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04066608

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University Medical Center of the Johannes Gutenber Univeristy
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
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Responsible Party: Priv.-Doz. Dr. J. Schattenberg, Jörn Schattenberg, MD; Head of the Metabolic Liver Research Program, Johannes Gutenberg University Mainz Identifier: NCT04066608    
Other Study ID Numbers: FLASH
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz:
Non-invasive Diagnostics
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases