CClinicalTrials.gg
Status unknownNCT04215926NAFLDIHUpdated Mar 4, 2020

NAFLD in HIV-infected Patients

An observational study in HIV-infection/Aids and NAFLD, sponsored by Shanghai Public Health Clinical Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Shanghai Public Health Clinical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • HIV-infection/Aids
  • NAFLD

Keywords

  • HIV infection
  • NAFLD
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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Shanghai Public Health Clinical Center is the lead sponsor of 37 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HIV-infected outpatients who was not coinfected with other form of viral hepatitis or drug induced liver disease, some severe systematic disease

Inclusion criteria

  • Age 18\~70 y;
  • HIV-positive patients;
  • written the informed consent

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HIV-monoinfected outpatients

    No intervention; cross-sectional study

    Other: No intervention; cross-sectional study

Interventions

  • OtherNo intervention; cross-sectional study

    No intervention; cross-sectional study

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What researchers measure

Primary outcomes

  1. morbidity of nonalcoholic fatty liver disease

    NAFLD was diagnosed using ultrasound

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
  • Shanghai Public Health Clinical Center
    Shanghai, Shanghai 201508, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04215926
Lead sponsor
Shanghai Public Health Clinical Center
Responsible party
Hongzhou Lu (professor, Shanghai Public Health Clinical Center) — Principal investigator
First posted
Jan 2, 2020
Start date
Dec 5, 2019
Primary completion
Oct 30, 2020 (estimated)
Completion
Nov 30, 2020 (estimated)
Last update
Mar 4, 2020

Study contacts

Hongzhou Lu, Ph.D
Contact
luhongzhou@fudan.edu.cn
+86-021-37990333 ext. 3222
Hongzhou Lu, PI
Contact
luhongzhou@fudan.edu.cn
+86-021-37990333 ext. 3222

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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