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Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)

Recruiting

HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.

What is being tested

Sponsor: Johns Hopkins University · Participants: 80 · Started: 2026-11

Contact the study team

Official record on ClinicalTrials.gov — NCT07665372

Locations in the U.S.

ArizonaMayo Clinic, Arizona, Phoenix (Not yet recruiting)
CaliforniaCedars-Sinai Medical Center, Los Angeles (Not yet recruiting)
University of California, San Francisco, San Francisco (Not yet recruiting)
ColoradoUniversity of Colorado Anschutz, Aurora (Not yet recruiting)
FloridaMayo Clinic, Florida, Jacksonville (Not yet recruiting)
University of Miami, Miami Transplant Institute, Miami (Not yet recruiting)
GeorgiaEmory University, Atlanta (Not yet recruiting)
IllinoisNorthwestern University, Chicago (Not yet recruiting)
LouisianaOchsner Clinic Foundation, Jefferson (Not yet recruiting)
MarylandJohns Hopkins University, Baltimore
MassachusettsMassachusetts General Hospital, Boston (Not yet recruiting)
New YorkIcahn School of Medicine at Mount Sinai, New York
New York University School of Medicine, New York (Not yet recruiting)
Weill Cornell Medical College, New York (Not yet recruiting)
OhioUniversity of Cincinnati, Cincinnati (Not yet recruiting)
Ohio State University Medical Center, Columbus (Not yet recruiting)
PennsylvaniaUniversity of Pittsburgh Medical Center, Pittsburgh (Not yet recruiting)
TexasUniversity of Texas Southwestern Medical Center, Dallas (Not yet recruiting)
Houston Methodist Research Institute, Houston (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.