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

23 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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-).

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: HIV D+/R+
People living with HIV who receive livers from deceased donors with HIV
Altro: HIV D+/R+
Receipt of liver transplant from a deceased donor with HIV
Sperimentale: HIV D-/R+
People living with HIV who receive livers from deceased donors without HIV
Altro: HIV D-/R+
Receipt of liver transplant from a deceased donor without HIV

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Johns Hopkins University

Collaboratori

National Institute of Allergy and Infectious Diseases (NIAID)

Investigatori

  • Investigatore principale: Christine Durand, MD, Johns Hopkins University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 agosto 2030

Completamento dello studio (Stimato)

1 agosto 2031

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IRB00450882
  • U01AI138897 (Sovvenzione/contratto NIH degli Stati Uniti)
  • RTB-024 (Altro identificatore: The National Institute of Allergy and Infectious Diseases (NIAID))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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