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

NCT07665372

Not Yet RecruitingNA

Sponsor: Johns Hopkins University

Conditions: HIV

Interventions: HIV D+/R+, HIV D-/R+

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (19)

Phoenix, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Jefferson, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States