HIV-Positive livers for HIV-Positive patients: a new hope?
NCT ID NCT07665372
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This study looks at whether people with HIV who need a liver transplant can safely receive a liver from a donor who also had HIV. Researchers will compare infections and cancer rates between those who get an HIV-positive donor liver and those who get an HIV-negative donor liver. The goal is to see if using HIV-positive organs is a safe option to help more people get transplants faster.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liver transplant from a donor with HIV
- What this could lead to
- If successful, this could show that using livers from HIV-positive donors is safe and effective for people with HIV, expanding the donor pool and reducing wait times.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly improve health. There may be higher risks of infections or cancer in recipients of HIV-positive donor livers.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 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.
- 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: * Participant meets local criteria for liver or simultaneous liver kidney (SLK) transplant. * Participant or legally authorized representative (in accordance with Johns Hopkins Medicine Institutional Review Board (IRB) and local IRB policy) is able to understand and provide informed consent. * Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA. * Participant is ≥ 18 years old. * Most recent HIV-1 RNA \< 50 copies RNA/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described. Exclusion Criteria: * Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month duration, or prior primary Central Nervous System (CNS) lymphoma. * Participant is pregnant or breastfeeding. * Past or current medical problems or findings from medical history, physical examination, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
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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.
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The places running it
19 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cedars-Sinai Medical Center
NOT_YET_RECRUITINGLos Angeles, California, 90048, United States
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Emory University
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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Houston Methodist Research Institute
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21205, United States
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Massachusetts General Hospital
NOT_YET_RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic, Arizona
NOT_YET_RECRUITINGPhoenix, Arizona, 85054, United States
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Mayo Clinic, Florida
NOT_YET_RECRUITINGJacksonville, Florida, 32224, United States
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New York University School of Medicine
NOT_YET_RECRUITINGNew York, New York, 10016, United States
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Northwestern University
NOT_YET_RECRUITINGChicago, Illinois, 60611, United States
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Ochsner Clinic Foundation
NOT_YET_RECRUITINGJefferson, Louisiana, 70121, United States
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Ohio State University Medical Center
NOT_YET_RECRUITINGColumbus, Ohio, 43210, United States
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University of California, San Francisco
NOT_YET_RECRUITINGSan Francisco, California, 94143, United States
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University of Cincinnati
NOT_YET_RECRUITINGCincinnati, Ohio, 45229, United States
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University of Colorado Anschutz
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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University of Miami, Miami Transplant Institute
NOT_YET_RECRUITINGMiami, Florida, 33136, United States
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University of Pittsburgh Medical Center
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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University of Texas Southwestern Medical Center
NOT_YET_RECRUITINGDallas, Texas, 75390, United States
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Weill Cornell Medical College
NOT_YET_RECRUITINGNew York, New York, 10065, United States
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