Clinical trial NCT06940375: Prevelence of Liver Disease-Related Outcomes in People With HIV
Official title: Construction of Prediction Models for Metabolic - Associated Fatty Liver Disease and Liver Fibrosis in HIV - Infected Individuals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: MAFLD
Liver Fibrosis
MASH
HIV
Metabolic Syndrome X
Hepatic Steatosis
Keywords: people with HIV
metabolic associated fatty liver disease
liver fibrosis
prognosis
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2025-04-23
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically diagnosed HIV

Brief 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.

Detailed description: Chronic liver injury caused by various etiologies can lead to liver fibrosis. Liver fibrosis refers to the imbalance between the synthesis and degradation of extracellular matrix in the liver under the influence of various pathogenic factors (viruses, ethanol, autoimmunity, steatosis). For HIV patients, the causes of liver fibrosis are more complex. Firstly, the impact of HIV infection itself, including chronic inflammation and immune activation caused by HIV.Secondly, the liver toxicity side effects of antiretroviral drugs and the immune reconstitution inflammatory syndrome that occurs in some patients at the beginning of treatment, causing liver inflammation and fibrosis.Third, combine various liver diseases-induced fibrosis, including metabolic associated fatty liver fibrosis, etc.In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance. APRI and FIB-4 are currently widely used non-invasive methods for assessing the severity of liver fibrosis.However, due to the more complex pathogenesis of liver fibrosis in HIV patients compared to the general population, the accuracy of APRI and FIB-4 in diagnosis may be affected. Recently, the Fibroscan - aspartate aminotransferase (FAST) score was established to identify high-risk patients with significant liver fibrosis (F2-F4) associated with metabolic associated steatohepatitis (MASH). The FAST score was calculated using the controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and aspartate aminotransferase (AST) level. Moreover, the FAST score has been validated in global clinical trials targeting metabolic associated steatohepatitis.However, in HIV-infected individuals, clinical trials targeting metabolic-associated fatty liver fibrosis are still lacking, and there is a lack of prognostic data for patients with HIV combined with MAFLD.

The investigators aim to explore the prevalence of the progression of MAFLD, evaluate the prognostic value of the FASTscore in predicting liver - related and extra - hepatic outcomes among PWH. Additionally, the investigators intend to integrate this with metabolomics to construct prediction models for MAFLD that are suitable for HIV - infected individuals.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 70 years old
2. HIV positive individuls
3. 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 Criteria:

1. Men with excessive alcohol consumption (more than 210g/week) and women with excessive alcohol consumption (more than 140g/week).
2. 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.
3. Pregnant women and lactating women.

Primary outcomes:
measure: Number of patients who progress from non - MAFLD to MAFLD
timeFrame: Baseline
measure: Number of patients who progress from non - MASH at risk to MASH at risk
timeFrame: Baseline
Secondary outcomes:
measure: Number of participants with cardiovascular events
timeFrame: Baseline
measure: Number of participants with extrahepatic tumors
timeFrame: Baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
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