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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV
• Intervention / Treatment: Other: HIV D+/R+; Other: HIV D-/R+

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-).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Durand, MD; Phone Number: 410-614-6702; Email: ChristineDurand@jhmi.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic, Arizona
      • Contact: Andrew Singer, MD, PhD; Email: Singer.Andrew@mayo.edu
      • Principal Investigator: Andrew Singer, MD, PhD
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
      • Contact: Nicholas Nissen, MD; Email: Nicholas.Nissen@cshs.org
      • Principal Investigator: Nicholas Nissen, MD
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Contact: Jennifer Price, MD; Email: Jennifer.Price@ucsf.edu
      • Principal Investigator: Jennifer Price, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz
      • Contact: Chia-Yu Chiu, MD; Email: chia-yu.chiu@cuanschutz.edu
      • Principal Investigator: Chia-Yu Chiu, MD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic, Florida
      • Principal Investigator: Shennen Mao, MD
      • Contact: Shennen Mao, MD; Email: Mao.Shennen@mayo.edu
    • Miami, Florida, United States, 33136
      • University of Miami, Miami Transplant Institute
      • Contact: Jacques Simkins-Cohen, MD; Email: jsimkins@med.miami.edu
      • Principal Investigator: Jacques Simkins-Cohen, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
      • Contact: William Kitchens, MD, PhD; Email: william.henry.kitchens.jr@emory.edu
      • Principal Investigator: William Kitchens, MD, PhD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
      • Contact: Valentina Stosor, MD; Email: v-stosor@northwestern.edu
      • Principal Investigator: Valentina Stosor, MD
  • Louisiana
    • Jefferson, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
      • Contact: Jonathan Hand, MD; Email: jonathan.hand@ochsner.org
      • Principal Investigator: Jonathan Hand, MD
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
      • Principal Investigator: Christine Durand, MD
      • Contact: Christine Durand, MD; Email: ChristineDurand@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Principal Investigator: Nahel Elias, MD
      • Contact: Nahel Elias, MD; Email: Elias.Nahel@mgh.harvard.edu
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
      • Principal Investigator: Catherine B Small, MD
      • Contact: Catherine B Small, MD; Email: cbs9003@med.cornell.edu
    • New York, New York, United States, 10016
      • New York University School of Medicine
      • Principal Investigator: Sapna Mehta, MD
      • Contact: Sapna Mehta, MD; Email: Sapna.Mehta@nyulangone.org
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
      • Contact: Sander Florman, MD
      • Principal Investigator: Sander Florman, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati
      • Principal Investigator: Senu Apewokin, MD
      • Contact: Senu Apewokin, MD; Email: apewoksu@ucmail.uc.edu
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
      • Contact: Nicholas Marschalk, DO; Email: Nicholas.Marschalk@osumc.edu
      • Principal Investigator: Nicholas Marschalk, DO
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • University of Pittsburgh Medical Center
      • Principal Investigator: Ghady Haidar, MD
      • Contact: Ghady Haidar, MD; Email: haidarg@upmc.edu
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Contact: David Wojciechowski, DO; Email: David.Wojciechowski@UTSouthwestern.edu
      • Principal Investigator: David Wojciechowski, DO
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
      • Contact: Masayuki Nigo, MD MSc; Email: mnigo@houstonmethodist.org
      • Principal Investigator: Masayuki Nigo, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV D+/R+; People living with HIV who receive livers from deceased donors with HIV	Other: HIV D+/R+; Receipt of liver transplant from a deceased donor with HIV
Experimental: HIV D-/R+; People living with HIV who receive livers from deceased donors without HIV	Other: HIV D-/R+; Receipt of liver transplant from a deceased donor without HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT	Cumulative incidence of composite event of opportunistic infection or cancer	From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant survival	Time to event (death)	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft survival	Time to event (graft loss)	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant	Cumulative incidence of infections	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence and type of post-transplant cancer as determined by local pathology	Cumulative incidence of cancer determined by local pathology	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Serious adverse events post-transplant	Cumulative incidence of serious adverse events	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of rejection events post-transplant	Cumulative incidence of rejection events	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft function over time measured by fibrosis-4 index and Aspartate Aminotransferase (AST) to Platelet Ratio Index	Mean value of graft function	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant	Cumulative incidence of HIV-breakthrough and HIV persistent viral failure	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant	Cumulative incidence of new resistance and/or X4 tropic virus based on local testing	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of surgical and vascular transplant complications during the first year post-transplant	Cumulative incidence of complications	From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Kaposi Sarcoma Herpesvirus (KSHV) serology and Polymerase Chain Reaction (PCR) over time	Count of positive KSHV serology and PCR	From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Christine Durand, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB00450882; U01AI138897 (U.S. NIH Grant/Contract); RTB-024 (Other Identifier: The National Institute of Allergy and Infectious Diseases (NIAID))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No