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

NCT07665372 | Not Yet Recruiting DMC

• 3 other identifiers: IRB00450882U01AI138897RTB-024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Participant survival

  From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)

• Graft survival

  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

  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

  From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)

• Serious adverse events post-transplant

  From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)

Study Arms (2)

HIV D+/R+

EXPERIMENTAL

People living with HIV who receive livers from deceased donors with HIV

Other: HIV D+/R+

HIV D-/R+

EXPERIMENTAL

People living with HIV who receive livers from deceased donors without HIV

Other: HIV D-/R+

Interventions

HIV D-/R+ OTHER

Receipt of liver transplant from a deceased donor without HIV

HIV D-/R+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (19)

Mayo Clinic, Arizona

Phoenix, Arizona, 85054, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Mayo Clinic, Florida

Jacksonville, Florida, 32224, United States

Location

University of Miami, Miami Transplant Institute

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Ochsner Clinic Foundation

Jefferson, Louisiana, 70121, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Study Officials

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Durand, MD

CONTACT

410-614-6702; ChristineDurand@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

US (19)