Liver Transplant from HIV+ Donors: See if HIV+ Recipients Do as Well

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines liver transplant outcomes in adults living with HIV who receive livers from donors with HIV compared to donors without HIV. It builds on the HOPE Act, allowing research use of HIV-positive donor organs. The trial follows recipients to monitor opportunistic infections, cancer risk, and long-term health while maintaining HIV control on ART. Participants must be able to consent, have documented HIV, and be eligible for liver or double-organ (liver-kidney) transplant. Sites include Johns Hopkins, Mayo Clinic, Cedars-Sinai, and UCSF.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• Mayo Clinic, Arizona
  Phoenix, Arizona, United States Not yet recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Not yet recruiting
• University of California, San Francisco
  San Francisco, California, United States Not yet recruiting
• University of Colorado Anschutz
  Aurora, Colorado, United States Not yet recruiting

Study contacts

• Principal investigator: Christine Durand, MD — Johns Hopkins University
• Study coordinator: Christine Durand, MD
• Email: ChristineDurand@jhmi.edu
• Phone: 410-614-6702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.