HIV-infection/AidsNAFLDIHNCT04215926
NAFLD in HIV-infected Patients
An observational study of HIV-infection/Aids and NAFLD, run by Shanghai Public Health Clinical Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV-infection/Aids, NAFLD
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2019to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected outpatients who was not coinfected with other form of viral hepatitis or drug induced liver disease, some severe systematic disease
Who may be able to join
- Age 18~70 y;
- HIV-positive patients;
- written the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
Official title: The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study
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.
- Conditions
- HIV-infection/Aids, NAFLD
- Being tested
- No intervention; cross-sectional study
- Keywords
- HIV infection, NAFLD
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Non-alcoholic Fatty Liver Disease, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; cross-sectional studyOther
No intervention; cross-sectional study
| Study group | Role | What they receive |
|---|---|---|
| HIV-monoinfected outpatients | No intervention; cross-sectional study Receives: Other: No intervention; cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity of nonalcoholic fatty liver disease
NAFLD was diagnosed using ultrasound
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start5 Dec 2019
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-infection/AidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215926
- Sponsor's protocol ID
- 20191126V2
- Acronym
- NAFLDIH
- Status last verified
- Mar 2020
- First submitted
- 29 Dec 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu W, Liu D, Zhang R, Chen J, Shen Y. Evaluation of ten diagnostic models for metabolic dysfunction-associated fatty liver disease in lean people living with HIV. BMC Infect Dis. 2025 Sep 26;25(1):1147. doi: 10.1186/s12879-025-11540-y.
PubMed 41013384Xu 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.
PubMed 40667432
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04215926
- Acronym / sponsor ID
- NAFLDIH / 20191126V2
- Conditions
- HIV-infection/Aids, NAFLD
- Keywords
- HIV infection, NAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-monoinfected outpatients | – | Other: No intervention; cross-sectional studyNo intervention; cross-sectional study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected outpatients who was not coinfected with other form of viral hepatitis or drug induced liver disease, some severe systematic disease
Key inclusion criteria (3 listed)
- Age 18~70 y;
- HIV-positive patients;
- written the informed consent
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; cross-sectional studyNo intervention; cross-sectional study | Other | HIV-monoinfected outpatients |
Primary outcome
morbidity of nonalcoholic fatty liver disease
Time frame: 1 month
NAFLD was diagnosed using ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 41013384Xu W, Liu D, Zhang R, Chen J, Shen Y. Evaluation of ten diagnostic models for metabolic dysfunction-associated fatty liver disease in lean people living with HIV. BMC Infect Dis. 2025 Sep 26;25(1):1147. doi: 10.1186/s12879-025-11540-y.
- Derived from this study: PubMed 40667432Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-infection/Aids and NAFLD, run by Shanghai Public Health Clinical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhou Lu, Ph.D (+86-021-37990333 ext. 3222, luhongzhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity of nonalcoholic fatty liver disease (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215926, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020; AzTrials last refreshed its copy on 1 Nov 2026.