Prevalence of Advanced Fibrosis in Patients Living With HIV

• Conditions: Fatty Liver Disease

• Registration Number: NCT04066608
• Lead Sponsor: Johannes Gutenberg University 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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28
• Primary Completion: 2028-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• informed consent
• age >18

Exclusion Criteria

• pregnancy
• disease with expectation of life under 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of significant hepatic fibrosis	1 year	Significant hepatic fibrosis defined as greater or equal to \>8,2 kPa meassured by transient elastography using a Fibroscan

Secondary Outcome Measures

Name	Time	Method
Prevalence of hepatic steatosis	1 year	Hepatic steatosis defined as greater or equal to 275 db/m measured by controlled attenuation parameter (CAP) using a Fibroscan
Incidence of events of interest (clinical outcome)	10 years	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)

Trial Locations

Locations (2)

University Medical Center of the Johannes Gutenberg University; 🇩🇪 Mainz, Germany

University Medical Center of the Johannes Gutenber Univeristy; 🇩🇪 Mainz, Germany