Prevalence of Advanced Fibrosis in Patients Living With HIV
FLASH
Cross-sectional Study on the Prevalence of Fatty Liver and Metabolic Risk Factors in an HIV-infected Population
1 other identifier
observational
300
1 country
2
Brief Summary
Monocentric, cross-sectional study to define the prevalence of advanced fibrosis in an HIV infected outpatient population. Follow-up over 10 years to assess clinical relevance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
2 active sites
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
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 17, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
December 28, 2023
December 1, 2023
10 years
August 17, 2019
December 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of significant hepatic fibrosis
Significant hepatic fibrosis defined as greater or equal to \>8,2 kPa meassured by transient elastography using a Fibroscan
1 year
Secondary Outcomes (2)
Prevalence of hepatic steatosis
1 year
Incidence of events of interest (clinical outcome)
10 years
Other Outcomes (1)
Quality of Life Meassures at Baseline and during Follow-up
10 yeras
Eligibility Criteria
Outpatient Study Population at the University Medical Center Mainz
You may qualify if:
- informed consent
- age \>18
You may not qualify if:
- pregnancy
- disease with expectation of life under 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Medical Center of the Johannes Gutenber Univeristy
Mainz, 55131, Germany
University Medical Center of the Johannes Gutenberg University
Mainz, 55131, Germany
Related Publications (2)
Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PMID: 19805654BACKGROUNDEuropean Association for Study of Liver; Asociacion Latinoamericana para el Estudio del Higado. EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J Hepatol. 2015 Jul;63(1):237-64. doi: 10.1016/j.jhep.2015.04.006. Epub 2015 Apr 21. No abstract available.
PMID: 25911335BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jörn Schattenberg, MD; Head of the Metabolic Liver Research Program
Study Record Dates
First Submitted
August 17, 2019
First Posted
August 26, 2019
Study Start
October 1, 2018
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
December 28, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share