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NCT07665372NARecruiting

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

Johns Hopkins University

Start Date

11/1/2026

Completion Date

8/1/2031

Summary

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.

Detailed Description

Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study. Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

HIV D+/R+

OTHER

HIV D-/R+

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Conditions

HIV

Locations

Mayo Clinic, Arizona

Phoenix, Arizona 85054

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of California, San Francisco

San Francisco, California 94143

United States

University of Colorado Anschutz

Aurora, Colorado 80045

United States

Mayo Clinic, Florida

Jacksonville, Florida 32224

United States

University of Miami, Miami Transplant Institute

Miami, Florida 33136

United States

Emory University

Atlanta, Georgia 30322

United States

Northwestern University

Chicago, Illinois 60611

United States

Ochsner Clinic Foundation

Jefferson, Louisiana 70121

United States

Johns Hopkins University

Baltimore, Maryland 21205

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

New York University School of Medicine

New York, New York 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Weill Cornell Medical College

New York, New York 10065

United States

University of Cincinnati

Cincinnati, Ohio 45229

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15224

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Houston Methodist Research Institute

Houston, Texas 77030

United States