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HIV-Positive livers safe for HIV-Positive patients? landmark trial results

NCT ID NCT03734393

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This study looked at whether it is safe to transplant livers from deceased HIV-positive donors into HIV-positive recipients. Researchers followed 80 participants to track complications like graft failure, infections, and HIV breakthrough. The goal was to see if using HIV-positive organs could safely expand the donor pool for people with HIV.

What this could mean

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

Active substance
Liver from an HIV-infected deceased donor
What this could lead to
If successful, this could expand the donor pool for HIV-positive patients needing liver transplants, reducing wait times and saving lives.
What could go wrong
This is a completed study with 80 participants, but results may not apply to all patients. Risks include graft failure, infections, and HIV-related complications.

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

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

80 people

The number who actually took part.

Started

Jan 2019

Finished

Jul 2025

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.

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: * Participant meets the standard criteria for liver transplant at the local center. * Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs. * Participant is able to understand and provide informed consent. * Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria. * Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).\* * Participant is ≥ 18 years old. * Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible. * CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present. * HIV-1 RNA is below 50 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 anti-retroviral 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. * Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management. * Participant is willing to comply with all medications related to participant's transplant and HIV management. * For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease. * Agreement to use contraception. * Participant is not suffering from significant wasting (e.g. body mass index \< 21) thought to be related to HIV disease. Exclusion Criteria: * Participant has a history of progressive multifocal leukoencephalopathy (PML), or primary central nervous system (CNS) lymphoma.\* * Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.) * 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.

AIDS chronic liver failure HIV infectious disease

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Georgetown Transplant Institute

    Washington D.C., District of Columbia, 20007, United States

  • New York University School of Medicine

    New York, New York, 11016, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • UPMC - University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California, San Diego

    San Diego, California, 92103, United States

  • University of California, San Francisco

    San Francisco, California, 94193, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Maryland, Institute of Human Virology

    Baltimore, Maryland, 21201, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Tennessee Health and Science Center

    Memphis, Tennessee, 38104, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8022, United States

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