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

8 september 2026 uppdaterad av: Johns Hopkins University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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-).

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85054
        • Har inte rekryterat ännu
        • Mayo Clinic, Arizona
        • Kontakt:
        • Huvudutredare:
          • Andrew Singer, MD, PhD
    • California
      • Los Angeles, California, Förenta staterna, 90048
        • Har inte rekryterat ännu
        • Cedars-Sinai Medical Center
        • Kontakt:
        • Huvudutredare:
          • Nicholas Nissen, MD
      • San Francisco, California, Förenta staterna, 94143
        • Har inte rekryterat ännu
        • University of California, San Francisco
        • Kontakt:
        • Huvudutredare:
          • Jennifer Price, MD
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Har inte rekryterat ännu
        • University of Colorado Anschutz
        • Kontakt:
        • Huvudutredare:
          • Chia-Yu Chiu, MD
    • Florida
      • Jacksonville, Florida, Förenta staterna, 32224
        • Har inte rekryterat ännu
        • Mayo Clinic, Florida
        • Huvudutredare:
          • Shennen Mao, MD
        • Kontakt:
      • Miami, Florida, Förenta staterna, 33136
        • Har inte rekryterat ännu
        • University of Miami, Miami Transplant Institute
        • Kontakt:
        • Huvudutredare:
          • Jacques Simkins-Cohen, MD
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Har inte rekryterat ännu
        • Northwestern University
        • Kontakt:
        • Huvudutredare:
          • Valentina Stosor, MD
    • Louisiana
      • Jefferson, Louisiana, Förenta staterna, 70121
        • Har inte rekryterat ännu
        • Ochsner Clinic Foundation
        • Kontakt:
        • Huvudutredare:
          • Jonathan Hand, MD
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21205
        • Rekrytering
        • Johns Hopkins University
        • Huvudutredare:
          • Christine Durand, MD
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Har inte rekryterat ännu
        • Massachusetts General Hospital
        • Huvudutredare:
          • Nahel Elias, MD
        • Kontakt:
    • New York
      • New York, New York, Förenta staterna, 10029
        • Rekrytering
        • Icahn School of Medicine at Mount Sinai
        • Kontakt:
          • Sander Florman, MD
        • Huvudutredare:
          • Sander Florman, MD
      • New York, New York, Förenta staterna, 10016
        • Har inte rekryterat ännu
        • New York University School of Medicine
        • Huvudutredare:
          • Sapna Mehta, MD
        • Kontakt:
      • New York, New York, Förenta staterna, 10065
        • Har inte rekryterat ännu
        • Weill Cornell Medical College
        • Huvudutredare:
          • Catherine B Small, MD
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229
        • Har inte rekryterat ännu
        • University of Cincinnati
        • Huvudutredare:
          • Senu Apewokin, MD
        • Kontakt:
      • Columbus, Ohio, Förenta staterna, 43210
        • Har inte rekryterat ännu
        • Ohio State University Medical Center
        • Kontakt:
        • Huvudutredare:
          • Nicholas Marschalk, DO
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15224
        • Har inte rekryterat ännu
        • University of Pittsburgh Medical Center
        • Huvudutredare:
          • Ghady Haidar, MD
        • Kontakt:
    • Texas
      • Dallas, Texas, Förenta staterna, 75390
        • Har inte rekryterat ännu
        • University of Texas Southwestern Medical Center
        • Kontakt:
        • Huvudutredare:
          • David Wojciechowski, DO
      • Houston, Texas, Förenta staterna, 77030
        • Har inte rekryterat ännu
        • Houston Methodist Research Institute
        • Kontakt:
        • Huvudutredare:
          • Masayuki Nigo, MD, MSc

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: HIV D+/R+
People living with HIV who receive livers from deceased donors with HIV
Övrig: HIV D+/R+
Receipt of liver transplant from a deceased donor with HIV
Experimentell: HIV D-/R+
People living with HIV who receive livers from deceased donors without HIV
Övrig: HIV D-/R+
Receipt of liver transplant from a deceased donor without HIV

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Participant survival
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Time to event (death)
From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft survival
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years 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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years 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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years 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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years 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
Tidsram: From transplant through end of follow up (at least 6 months, up to 4 years 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
Tidsram: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Cumulative incidence of complications
From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johns Hopkins University

Samarbetspartners

National Institute of Allergy and Infectious Diseases (NIAID)

Utredare

  • Huvudutredare: Christine Durand, MD, Johns Hopkins University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

1 augusti 2030

Avslutad studie (Beräknad)

1 augusti 2031

Studieregistreringsdatum

Först inskickad

18 juni 2026

Först inskickad som uppfyllde QC-kriterierna

18 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • IRB00450882
  • U01AI138897 (U.S.S. NIH-anslag/kontrakt)
  • RTB-024 (Annan identifierare: The National Institute of Allergy and Infectious Diseases (NIAID))

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