HIV and fatty liver: a hidden risk revealed?
NCT ID NCT04795219
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
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About 1,250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Duke University
Durham, North Carolina, 27701, United States
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Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
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John Hopkins University
Baltimore, Maryland, 21287, United States
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University of Alabama
Tuscaloosa, Alabama, 35487, United States
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University of California, San Diego
La Jolla, California, 92037, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Texas
Houston, Texas, 77030, United States
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Virginia Commonwealth University
Richmond, Virginia, 23284, United States
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Other studies related to the condition(s) this trial covers.
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