Prevalence of Advanced Fibrosis in Patients Living With HIV

Fatty Liver Disease Clinical Trial

— FLASH  

Official title:

Cross-sectional Study on the Prevalence of Fatty Liver and Metabolic Risk Factors in an HIV-infected Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04066608
• Other study ID #: 18-00379
• Status: Enrolling by invitation
• Start date: October 1, 2018
• Est. completion date: October 1, 2028

Study information

• Verified date: December 2023
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: October 1, 2028
• Est. primary completion date: October 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent

• age >18

Exclusion Criteria:

• pregnancy

• disease with expectation of life under 12 months

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
Germany	University Medical Center of the Johannes Gutenber Univeristy	Mainz
Germany	University Medical Center of the Johannes Gutenberg University	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Meassures at Baseline and during Follow-up	Health-related quality of life will be measured and reported using generic (EQ-5D) and disease-specific tools (MOS-HIV)	10 yeras
Primary	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	Prevalence of hepatic steatosis	Hepatic steatosis defined as greater or equal to 275 db/m measured by controlled attenuation parameter (CAP) using a Fibroscan	1 year
Secondary	Incidence of events of interest (clinical outcome)	Over the 10 year follow-up time, (1) overall mortality, (2) the incidence of AIDS-associated and defining diseases (according to the CDC classification) and (3) metabolic morbidity including incidence of cardiovascular disease (CVD), type 2 diabetes, hyperlipidemia, renal function impairment, arterial hypertension (according to the International Diabetes Federation Task Force on Epidemiology) and (4) liver related-morbidity (according to the EASL; https://easl.eu/wp-content/uploads/2018/10/Non-invasive-English-report.pdf)	10 years