Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV

Starting soon

Conditions studied: MASLD, HIV (Human Immunodeficiency Virus)

In brief

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.

Key facts

Study ID

NCT07640880

Run by

Yinzhong Shen

People needed

120

Starts

2026-06-01

Expected to finish

2026-09-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-80 years
• Able to provide written informed consent and cooperate with blood sample collection and clinical data recording
• For Group 1 (Treatment-naive people with HIV and MASLD):
• 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
• For Group 2 (HIV-negative individuals with MASLD):
• HIV-negative
• Diagnosis of MASLD as defined above
• For Group 3 (Healthy Controls):
• HIV-negative
• Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis
• Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg/m²)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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