NAFLD in HIV-infected Patients

NAFLD Clinical Trial

— NAFLDIH  

Official title:

The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215926
• Other study ID #: 20191126V2
• Status: Recruiting
• Start date: December 5, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2020
• Source: Shanghai Public Health Clinical Center
• Contact: Hongzhou Lu, Ph.D
• Phone: +86-021-37990333
• Email: luhongzhou[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18~70 y;

• HIV-positive patients;

• written the informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• HIV Infections
• HIV-infection/Aids
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• No intervention; cross-sectional study
No intervention; cross-sectional study

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity of nonalcoholic fatty liver disease	NAFLD was diagnosed using ultrasound	1 month