NAFLD in HIV-infected Patients

NCT ID: NCT04215926

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-05

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-infection/Aids NAFLD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV-monoinfected outpatients

No intervention; cross-sectional study

No intervention; cross-sectional study

Intervention Type OTHER

No intervention; cross-sectional study

Interventions

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No intervention; cross-sectional study

No intervention; cross-sectional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hongzhou Lu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongzhou Lu, Ph.D

Role: CONTACT

+86-021-37990333 ext. 3222

Hongzhou Lu, PI

Role: CONTACT

+86-021-37990333 ext. 3222

References

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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.

Reference Type DERIVED
PMID: 40667432 (View on PubMed)

Other Identifiers

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20191126V2

Identifier Type: -

Identifier Source: org_study_id

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