Clinical trial NCT04066608: Prevalence of Advanced Fibrosis in Patients Living With HIV
Official title: Cross-sectional Study on the Prevalence of Fatty Liver and Metabolic Risk Factors in an HIV-infected Population
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fatty Liver Disease
Keywords: Non-invasive Diagnostics
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient Study Population at the University Medical Center Mainz

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.

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.

Eligibility criteria: Inclusion Criteria:

* informed consent
* age \>18

Exclusion Criteria:

* pregnancy
* disease with expectation of life under 12 months

Primary outcomes:
measure: Prevalence of significant hepatic fibrosis
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of hepatic steatosis
timeFrame: 1 year
measure: Incidence of events of interest (clinical outcome)
timeFrame: 10 years
Other outcomes:
measure: Quality of Life Meassures at Baseline and during Follow-up
timeFrame: 10 yeras
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenber Univeristy
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg University
Study officials:
References:
citation: 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.
citation: European 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.