Incidence of Liver Disease-Related Outcomes in People With HIV (PWH)

May 30, 2026 updated by: Yinzhong Shen, Shanghai Public Health Clinical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Observational

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201508
        • Shanghai Public Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinically diagnosed HIV

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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):

  1. 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
  2. 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)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with cardiovascular events
Time Frame: Baseline
cardiovascular events include myocardial infarction, arrhythmia and heart failure
Baseline
Number of participants with extrahepatic tumors
Time Frame: Baseline
these will be assessed as open-ended questions
Baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

February 26, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GKT1190
  • SHDC22024317 (Other Grant/Funding Number: Shanghai Hospital Development Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient Privacy Issues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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