Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease

NCT05330923 | Recruiting

• 1 other identifier: PekingUMCH record HS-3401D
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Identifying patients at risk of NAFLD(Nonalcoholic fatty liver disease), especially severe disease with NASH(nonalcoholic steatohepatitis) and fibrosis, is critical. Prevalence of NAFLD in PLWH(People Living With HIV) evaluated by different imaging techniques including US (ultrasonography), elastography, CT(computed tomography ), and magnetic resonance varies from 13% to 58.6% in all published studies. In previous studies, the effect of ART(Anti-Retroviral Therapy) on NAFLD was limited. A cross-sectional analysis found that INSTI（Integrase strand transfer inhibitor） was associated with a higher prevalence of steatosis in AIDS (acquired immunodeficiency syndrome) patients. However, it is not clear whether there is a difference in the degree of nonalcoholic steatosis between AIDS patients receiving NNRTI(non-nucleoside reverse transcriptase inhibitors). Therefore, the investigators plan to conduct a prospective study to assess whether there is any difference in the degree of nonalcoholic steatosis and fibrosis between Chinese HIV(human immunodeficiency virus)/AIDS patients after initial treatment with NNRTI or INSTI, or switching from NNRTI to INSTI.

Conditions

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Fibrosis; HIV/AIDS

Keywords

integrase inhibitors; non-nucleoside reverse transcriptase inhibitors; transient elastography; iLivTouch

Outcome Measures

Primary Outcomes (1)

• The degree of hepatic steatosis and fibrosis

  The ultrasound attenuation parameter(UAP) and liver stiffness in HIV/AIDS patients treated with either of INSTI and NNRTI for at least 12 months.

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly treated or treated AIDS patients

You may qualify if:

• Newly treated or treated AIDS patients;
• Regular follow-up visits to the hospital, medication compliance is good;
• Patients or their family members were willing to participate in the study by understanding the study plan and providing written informed consent.

You may not qualify if:

• Unable to complete the position requirements of ultrasonic examination (lying flat) due to mobility difficulties;
• Patients have poor compliance and cannot follow up regularly or take medicine on time;
• Patients or family members cannot understand the conditions and objectives of the study;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Wuxi Hisky Medical Technology Co Ltd: collaborator

Study Sites (1)

Chinese Academy of Medical Sciences Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• WEI Lyu

  Department of Infectious Diseases, PekingUMCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

QING ZHANG

CONTACT

15001278131; zhangqingpumch@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-10

Locations

CN (1)