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Enrolling by Invitation

NCT Number: NCT04066608

Prevalence of Advanced Fibrosis in Patients Living With HIV

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.

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Key information

Conditions

Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of the Johannes Gutenber Univeristy, Mainz, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent
  • age >18

Exclusion criteria

  • pregnancy
  • disease with expectation of life under 12 months

Treatment and study plan

Primary outcomes

  1. Prevalence of significant hepatic fibrosis

    Time frame: 1 year

    Significant hepatic fibrosis defined as greater or equal to >8,2 kPa meassured by transient elastography using a Fibroscan

Secondary outcomes

  1. Prevalence of hepatic steatosis

    Time frame: 1 year

    Hepatic steatosis defined as greater or equal to 275 db/m measured by controlled attenuation parameter (CAP) using a Fibroscan

  2. Incidence of events of interest (clinical outcome)

    Time frame: 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 outcomes

  1. Quality of Life Meassures at Baseline and during Follow-up

    Time frame: 10 yeras

    Health-related quality of life will be measured and reported using generic (EQ-5D) and disease-specific tools (MOS-HIV)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: FLASH

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2019
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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