Incidence of Liver Disease-Related Outcomes in People With HIV

NCT06940375 | Recruiting

• 2 other identifiers: GKT1190SHDC22024317
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

MAFLD; Liver Fibrosis; MASH; HIV; Hepatic Steatosis; Metabolic Syndrome (MetS)

Keywords

people with HIV; metabolic associated fatty liver disease; liver fibrosis; prognosis

Outcome Measures

Primary Outcomes (3)

• Number of patients who progress from non - MAFLD to MAFLD

  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

  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

  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 Outcomes (3)

• Number of participants with cardiovascular events

  Baseline

• Number of participants with extrahepatic tumors

  Baseline

• Lipidomic signature of MASLD-related significant fibrosis

  baseline

Interventions

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.

Also known as: TE, BIA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically diagnosed HIV

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (2)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

NOT YET RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

Related Publications (8)

• Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.

  PMID: 32027858 RESULT

• Cervo A, Shengir M, Patel K, Sebastiani G. NASH in HIV. Curr HIV/AIDS Rep. 2020 Dec;17(6):601-614. doi: 10.1007/s11904-020-00531-0.

  PMID: 32984925 RESULT

• Kaspar MB, Sterling RK. Mechanisms of liver disease in patients infected with HIV. BMJ Open Gastroenterol. 2017 Oct 26;4(1):e000166. doi: 10.1136/bmjgast-2017-000166. eCollection 2017.

  PMID: 29119002 RESULT

• Rivera CG, Otto AO, Zeuli JD, Temesgen Z. Hepatotoxicity of contemporary antiretroviral drugs. Curr Opin HIV AIDS. 2021 Nov 1;16(6):279-285. doi: 10.1097/COH.0000000000000706.

  PMID: 34545037 RESULT

• Fan JG, Xu XY, Yang RX, Nan YM, Wei L, Jia JD, Zhuang H, Shi JP, Li XY, Sun C, Li J, Wong VW, Duan ZP; Chinese Society of Hepatology, Chinese Medical Association. Guideline for the Prevention and Treatment of Metabolic Dysfunction-associated Fatty Liver Disease (Version 2024). J Clin Transl Hepatol. 2024 Nov 28;12(11):955-974. doi: 10.14218/JCTH.2024.00311. Epub 2024 Nov 4.

  PMID: 39544247 RESULT

• Navarro J. HIV and liver disease. AIDS Rev. 2022;25(2):87-96. doi: 10.24875/AIDSRev.M22000052.

  PMID: 35901073 RESULT

• Acquired Immunodeficiency Syndrome Professional Group, Society of Infectious Diseases, Chinese Medical Association; Chinese Center for Disease Control and Prevention. Chinese guidelines for the diagnosis and treatment of human immunodeficiency virus infection/acquired immunodeficiency syndrome (2024 edition). Chin Med J (Engl). 2024 Nov 20;137(22):2654-2680. doi: 10.1097/CM9.0000000000003383. Epub 2024 Nov 18.

  PMID: 39602327 RESULT

• European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.

  PMID: 38851997 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Ten milliliters of fasting blood samples will be collected for the extraction of whole blood, plasma and peripheral blood mononuclear cells (PBMCs) to meet research requirements.

MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yinzhong Shen, PhD

CONTACT

+8618916113951; shenyinzhong@shphc.org.cn

Wei Xu, PhD

CONTACT

+86 13660308971; 24111300008@m.fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 23, 2025
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)