Prevalence of Advanced Fibrosis in Patients Living With HIV

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04066608

Acronym

FLASH

Enrollment

300

Registered

2019-08-26

Start date

2018-10-01

Completion date

2028-10-01

Last updated

2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver Disease

Keywords

Non-invasive Diagnostics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* informed consent * age \>18

Exclusion criteria

* pregnancy * disease with expectation of life under 12 months

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Quality of Life Meassures at Baseline and during Follow-up	10 yeras	Health-related quality of life will be measured and reported using generic (EQ-5D) and disease-specific tools (MOS-HIV)

Countries

Germany

Outcome results