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

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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-).

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HIV D+/R+
People living with HIV who receive livers from deceased donors with HIV
Autre: HIV D+/R+
Receipt of liver transplant from a deceased donor with HIV
Expérimental: HIV D-/R+
People living with HIV who receive livers from deceased donors without HIV
Autre: HIV D-/R+
Receipt of liver transplant from a deceased donor without HIV

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Participant survival
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Johns Hopkins University

Collaborateurs

National Institute of Allergy and Infectious Diseases (NIAID)

Les enquêteurs

  • Chercheur principal: Christine Durand, MD, Johns Hopkins University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 août 2030

Achèvement de l'étude (Estimé)

1 août 2031

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IRB00450882
  • U01AI138897 (Subvention/contrat des NIH des États-Unis)
  • RTB-024 (Autre identifiant: The National Institute of Allergy and Infectious Diseases (NIAID))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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