Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

23. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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-).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins University

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Ledende efterforsker: Christine Durand, MD, Johns Hopkins University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. august 2030

Studieafslutning (Anslået)

1. august 2031

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV

Kliniske forsøg med HIV D+/R+

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Papua New Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner