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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Johns Hopkins University
Study ID
NCT07665372
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HIV D+/R+ — OTHER
    Receipt of liver transplant from a deceased donor with HIV
  • HIV D-/R+ — OTHER
    Receipt of liver transplant from a deceased donor without HIV

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HIV D+/R+
    People living with HIV who receive livers from deceased donors with HIV
  • Experimental: HIV D-/R+
    People living with HIV who receive livers from deceased donors without HIV

Primary Outcome Measure

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

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Mayo Clinic, ArizonaPhoenixArizona85054
Andrew Singer, MD, PhD
Andrew Singer, MD, PhD (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Nicholas Nissen, MD
Nicholas Nissen, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Jennifer Price, MD
Jennifer Price, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado AnschutzAuroraColorado80045
Chia-Yu Chiu, MD
Chia-Yu Chiu, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic, FloridaJacksonvilleFlorida32224
Shennen Mao, MD
Shennen Mao, MD (PRINCIPAL_INVESTIGATOR)
University of Miami, Miami Transplant InstituteMiamiFlorida33136
Jacques Simkins-Cohen, MD
Jacques Simkins-Cohen, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
William Kitchens, MD, PhD
William Kitchens, MD, PhD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Valentina Stosor, MD
Valentina Stosor, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Clinic FoundationJeffersonLouisiana70121
Jonathan Hand, MD
Jonathan Hand, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21205
Christine Durand, MD
Christine Durand, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Nahel Elias, MD
Nahel Elias, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Sander Florman, MD
Sander Florman, MD (PRINCIPAL_INVESTIGATOR)
New York University School of MedicineNew YorkNew York10016
Sapna Mehta, MD
Sapna Mehta, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10065
Catherine B Small, MD
Catherine B Small, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45229
Senu Apewokin, MD
Senu Apewokin, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Medical CenterColumbusOhio43210
Nicholas Marschalk, DO
Nicholas Marschalk, DO (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15224
Ghady Haidar, MD
Ghady Haidar, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
David Wojciechowski, DO
David Wojciechowski, DO (PRINCIPAL_INVESTIGATOR)
Houston Methodist Research InstituteHoustonTexas77030
Masayuki Nigo, MD MSc
Masayuki Nigo, MD, MSc (PRINCIPAL_INVESTIGATOR)

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