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HIV and fatty liver: a hidden risk revealed?

NCT ID NCT04795219

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 often fatty liver disease occurs in people living with HIV. Researchers will measure liver fat in 1,250 adults with HIV who are on stable treatment. The goal is to understand the true scale of this liver condition in this group, which has been largely overlooked in past research.

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 1,250 people

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

Started

Jul 2021

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Clinically diagnosed HIV-1, historically documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 18 years of age or older * HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA. * On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry Exclusion Criteria: * Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in serum at any time prior to enrollment (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded) * Evidence of recent or current HCV as marked by the presence of anti-HCV antibody with detectable HCV RNA in serum within 3 years prior to enrollment. Participants with anti-HCV antibody positivity who have undetectable HCV RNA 3 years prior to enrollment (either due to spontaneous clearance or clearance with treatment) will be eligible to participate if HCV RNA at entry remains undetected. * Known other chronic liver disease, including but not limited to alpha-1- antitrypsin deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease is not exclusionary. * Disseminated or advanced malignancy * Pregnancy * Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures * Inability to complete a FibroScan® VCTE scan: * Use of implantable active medical device such as a pacemaker or defibrillator * Wound care near the application site of the FibroScan® * Pregnancy * Ascites (fluid in the abdominal area) * Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam * Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures * Inability to complete the informed consent process or comply with study procedures

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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.

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27701, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • John Hopkins University

    Baltimore, Maryland, 21287, United States

  • University of Alabama

    Tuscaloosa, Alabama, 35487, United States

  • University of California, San Diego

    La Jolla, California, 92037, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Texas

    Houston, Texas, 77030, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

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Other studies related to the condition(s) this trial covers.