About this trial
Metabolic dysfunction-associated steatotic liver disease (MASLD), commonly known as fatty liver disease, is increasingly prevalent worldwide. People living with HIV (PWH) face a higher risk of developing MASLD due to chronic immune activation and long-term antiretroviral therapy, yet whether the underlying biological changes differ from those in HIV-negative individuals with MASLD remains unknown.
This prospective observational study will enroll three groups: PWH with MASLD, HIV-negative individuals with MASLD, and healthy controls without liver disease. A single fasting blood sample will be collected from each participant. Using targeted lipidomics, proteomics, and transcriptomics platforms, researchers will compare plasma molecular profiles across the three groups to identify MASLD-specific lipid signatures, characterize metabolic pathway dysregulation, and discover potential blood-based biomarkers for non-invasive diagnosis of MASLD.
Findings from this study may help explain how HIV infection alters lipid metabolism in the context of MASLD and support the development of HIV-specific diagnostic tools for fatty liver disease.
Eligibility criteria
Qualifiers
Age 18-80 years
Able to provide written informed consent and cooperate with blood sample collection and clinical data recording
Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive)
Diagnosis of MASLD per the 2024 Chinese Guidelines: hepatic steatosis confirmed by imaging or histology (≥5% macrovesicular steatosis), exclusion of excessive alcohol consumption (>210 g/week for men, >140 g/week for women), and at least one metabolic cardiovascular risk factor
Disqualifiers
Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation
Pregnancy or lactation
Active severe infectious disease (other than HIV for Group 1)
Severe critical illness or major organ failure
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Yinzhong Shen
Lead sponsor
Shanghai Public Health Clinical Center
Sponsor institution