HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

Completed · Not applicable

Conditions studied: Hiv

In brief

The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications

Key facts

Study ID: NCT03734393
Run by: Johns Hopkins University
People needed: 80
Starts: 2019-01-04
Expected to finish: 2025-07-04
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Alabama, Birmingham — Birmingham, Alabama, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
University of California, San Diego — San Diego, California, United States
University of California, San Francisco — San Francisco, California, United States
Yale University School of Medicine — New Haven, Connecticut, United States
MedStar Georgetown Transplant Institute — Washington D.C., District of Columbia, United States
University of Miami — Miami, Florida, United States
Emory University — Atlanta, Georgia, United States
Northwestern University — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Illinois at Chicago — Chicago, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
Ochsner Clinic Foundation — New Orleans, Louisiana, United States
University of Maryland, Institute of Human Virology — Baltimore, Maryland, United States
Johns Hopkins University — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Columbia University Medical Center — New York, New York, United States
Weill Cornell Medical College — New York, New York, United States
New York University School of Medicine — New York, New York, United States
University of Cincinnati — Cincinnati, Ohio, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
UPMC - University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
University of Tennessee Health and Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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