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Completed

NCT Number: NCT06940375

Incidence of Liver Disease-Related Outcomes in People With HIV

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.

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Key information

Conditions

MAFLD Digestive System Diseases Fatty Liver Fibrosis Glucose Metabolism Disorders HIV Hepatic Steatosis Hyperinsulinism Insulin Resistance Liver Cirrhosis Liver Diseases Liver Fibrosis MASH Metabolic Diseases Metabolic Syndrome Metabolic Syndrome (MetS) Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

About this study

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.

This study employed a retrospectively constructed cohort with prospective longitudinal follow-up. The investigators aim to Investigate the 5-year incidence and progression of hepatic steatosis and liver fibrosis in PWH using serial CAP and LSM. Additionally, the investigators intend to integrate this with metabolomics to construct prediction models for MAFLD that are suitable for HIV - infected individuals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Abdominal ultrasound , Fibroscan and body composition analysis examination

Other

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.

Other names: TE, BIA

Primary outcomes

  1. Number of patients who progress from non - MAFLD to MAFLD

    Time frame: Baseline

    Patients will be divided into three groups based on the different severity characteristics of metabolic-associated fatty liver disease (MAFLD).

    One group consists of patients with non - metabolic - associated fatty liver. Another group is composed of patients with metabolic - associated fatty liver but not at risk of metabolic (dysfunction) - associated steatohepatitis (MASH). The last group is the one at risk of MASH.

    The diagnosis of metabolic - associated fatty liver disease (MAFLD) is based on abdominal ultrasound, Fibroscan, and metabolic status.

    A cutoff of FAST>0.35 is used to define MASH at risk.

  2. Number of participants with hepatic steatosis progression

    Time frame: Baseline

    Count and proportion of participants who, among those with a baseline controlled attenuation parameter (CAP) value less than 292 decibels per meter (dB/m), either (a) newly develop hepatic steatosis of any grade-defined per the study protocol as CAP at or above the prespecified threshold for steatosis-or (b) transition to severe hepatic steatosis, defined as CAP at or above 292 dB/m. CAP will be measured using vibration-controlled transient elastography (FibroScan device) with concurrent CAP assessment at scheduled study visits, following standardized acquisition and quality control procedures.

  3. Number of participants with liver fibrosis progression

    Time frame: Baseline

    Count and proportion of participants who meet either of the following criteria, with all thresholds prespecified and liver stiffness measured in kilopascals using vibration-controlled transient elastography (VCTE; FibroScan device):

    • Incident significant liver fibrosis among those without significant fibrosis at baseline, defined as any follow-up liver stiffness measurement (LSM) ≥ 7.1 kPa (corresponding to fibrosis stages F2-F4 per protocol); or
    • Transition to cirrhosis among those with baseline LSM ≥ 7.1 kPa and < 12.5 kPa, defined as any follow-up LSM > 12.5 kPa (corresponding to fibrosis stage F4)

Secondary outcomes

  1. Number of participants with cardiovascular events

    Time frame: Baseline

    cardiovascular events include myocardial infarction, arrhythmia and heart failure

  2. Number of participants with extrahepatic tumors

    Time frame: Baseline

    these will be assessed as open-ended questions

  3. Lipidomic signature of MASLD-related significant fibrosis

    Time frame: baseline

    Plasma lipidomics-derived signature to discriminate ≥F2 fibrosis, reporting AUROC, sensitivity, specificity, and optimal decision threshold (Youden's J), using same-day LSM as the reference standard. Internal cross-validation and bootstrap confidence intervals will assess robustness.

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Registry information

Official study title

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

Acronym: PWH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Jun 2, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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