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HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients | Clinical Trials | Clareo Health

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

HOPE in Action Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

NCT03734393•Johns Hopkins University

Summary

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

Detailed Description

This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a liver from an HIV-uninfected deceased liver donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant meets the standard criteria for liver transplant at the local center.
•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.
+4 more criteria

Exclusion Criteria

•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.

Locations (26)

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

Key Dates

Start Date

January 4, 2019

Primary Completion Date

June 12, 2025

Completion Date

April 30, 2026

Last Updated

March 9, 2026

Enrollment

ACTUAL participants

Conditions

Hiv

Interventions

HIVD+/R+

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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