RecruitingNCT06940375

Incidence of Liver Disease-Related Outcomes in People With HIV

Construction of Prediction Models for Metabolic - Associated Fatty Liver Disease and Liver Fibrosis in HIV - Infected Individuals


Sponsor

Shanghai Public Health Clinical Center

Enrollment

320 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Antiretroviral therapy can effectively control the replication of HIV, prolong the lifespan of patients infected with HIV, and improve their quality of life.At the same time, non-AIDS-related diseases such as diabetes and chronic liver diseases are increasing day by day.Metabolic associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by overnutrition and insulin resistance in genetically susceptible individuals. It was formerly known as non-alcoholic fatty liver disease (NAFLD).With the continuous improvement of living standards and the constant change of lifestyles, the incidence of metabolic associated fatty liver disease is gradually increasing. Metabolic associated steatohepatitis (MASH) may further develop into liver cirrhosis, liver failure and hepatocellular carcinoma, and is the third most common cause of liver transplantation. In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance.However, due to the fact that the pathogenesis of liver fibrosis in HIV patients is more complex than that in the general population, it involves multiple factors such as the virus, reverse transcriptase drugs, chronic inflammation, and immune disorders.However, the current clinical research on metabolic-related fatty liver fibrosis in people with HIV is still rather limited.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Aged between 18 and 70 years old
  • HIV positive individuls
  • Had abdominal ultrasound and Fibroscan done between December 2019 and April 2020, with available data of LSM and CAP, and had routine follow - up at our hospital's outpatient department from April 2020 to April 2025.

Exclusion Criteria3

  • Men with excessive alcohol consumption (more than 210g/week) and women with excessive alcohol consumption (more than 140g/week).
  • Suffering from other liver diseases, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, decompensated liver cirrhosis, liver malignancy, or having had a liver transplantation.
  • Pregnant women and lactating women.

Interventions

OTHERAbdominal ultrasound , Fibroscan and body composition analysis examination

Abdominal ultrasound and Fibroscan examinations were conducted to obtain LSM, CAP, and calculate the FAST score. Bioelectrical impedance analysis was performed to obtain the content of subcutaneous and visceral fat.


Locations(2)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

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NCT06940375


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