NAFLD in HIV-infected Patients
NAFLDIH
The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study
1 other identifier
observational
400
1 country
1
Brief Summary
The prevalence of NAFLD (nonalcoholic fatty liver disease) in HIV-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. The investigators are planning to consecutively enroll 400 cases HIV-positive outpatients, and to detect NAFLD by ultrasound. The fecal and blood samples were also collected to explore the mechanism of NAFLD. The investigators aimed to determine the prevalence and risk factors of NAFLD in HIV infected patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2019
CompletedFirst Submitted
Initial submission to the registry
December 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedMarch 4, 2020
March 1, 2020
11 months
December 29, 2019
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
morbidity of nonalcoholic fatty liver disease
NAFLD was diagnosed using ultrasound
1 month
Study Arms (1)
HIV-monoinfected outpatients
No intervention; cross-sectional study
Interventions
No intervention; cross-sectional study
Eligibility Criteria
HIV-infected outpatients who was not coinfected with other form of viral hepatitis or drug induced liver disease, some severe systematic disease
You may qualify if:
- Age 18\~70 y;
- HIV-positive patients;
- written the informed consent
You may not qualify if:
- coinfected with HBV, HCV;
- secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and decompensated liver disease;
- significant alcohol consumption (\>20 g per day for man, \>10 g per day for woman);
- received antibiotics in preceding two months;
- autoimmune disease;
- severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
- pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
Related Publications (1)
Xu W, Liu D, Zhang R, Chen J, Shen Y. Prevalence and Risk Factors of Liver Fibrosis Among People With HIV and Metabolic Dysfunction-Associated Steatotic Liver Disease. Open Forum Infect Dis. 2025 Jul 2;12(7):ofaf369. doi: 10.1093/ofid/ofaf369. eCollection 2025 Jul.
PMID: 40667432DERIVED
Biospecimen
Blood and fecal sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 29, 2019
First Posted
January 2, 2020
Study Start
December 5, 2019
Primary Completion
October 30, 2020
Study Completion
November 30, 2020
Last Updated
March 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share