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HIV and fatty liver: scientists hunt for hidden clues in the blood

NCT ID NCT07640880

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how HIV might change the way the body handles fats in the liver, leading to fatty liver disease. Researchers will collect one blood sample from 120 adults: people with HIV and fatty liver, people without HIV but with fatty liver, and healthy controls. By analyzing fats, proteins, and genetic material in the blood, they hope to find unique markers that could lead to better diagnosis for fatty liver in people with HIV.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how HIV changes fat metabolism in the liver and lead to better, non-invasive blood tests for fatty liver disease in people with HIV.
What could go wrong
This is an early observational study, not a treatment trial. It only looks at blood samples at one time point, so it cannot prove cause and effect or lead directly to a new therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants are recruited from a single tertiary hospital (Shanghai Public Health Clinical Center): (1) treatment-naive people with HIV and MASLD from the outpatient Department of Infection and Immunity; (2) HIV-negative individuals with MASLD identified through the hospital's Health Management Center; and (3) healthy controls without liver disease from the same Health Management Center, matched to MASLD groups by age, sex, and BMI.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-80 years * Able to provide written informed consent and cooperate with blood sample collection and clinical data recording For Group 1 (Treatment-naive people with HIV and MASLD): * Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive) * Diagnosis of MASLD per the 2024 Chinese Guidelines: hepatic steatosis confirmed by imaging or histology (≥5% macrovesicular steatosis), exclusion of excessive alcohol consumption (\>210 g/week for men, \>140 g/week for women), and at least one metabolic cardiovascular risk factor For Group 2 (HIV-negative individuals with MASLD): * HIV-negative * Diagnosis of MASLD as defined above For Group 3 (Healthy Controls): * HIV-negative * Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis * Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg/m²) Exclusion Criteria: * Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation * Pregnancy or lactation * Active severe infectious disease (other than HIV for Group 1) * Severe critical illness or major organ failure

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 201508, China

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