Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)
8. september 2026 oppdatert 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.
Studieoversikt
Detaljert 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-).
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Christine Durand, MD
- Telefonnummer: 410-614-6702
- E-post: ChristineDurand@jhmi.edu
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Har ikke rekruttert ennå
- Mayo Clinic, Arizona
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Ta kontakt med:
- Andrew Singer, MD, PhD
- E-post: Singer.Andrew@mayo.edu
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Hovedetterforsker:
- Andrew Singer, MD, PhD
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California
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Los Angeles, California, Forente stater, 90048
- Har ikke rekruttert ennå
- Cedars-Sinai Medical Center
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Ta kontakt med:
- Nicholas Nissen, MD
- E-post: Nicholas.Nissen@cshs.org
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Hovedetterforsker:
- Nicholas Nissen, MD
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San Francisco, California, Forente stater, 94143
- Har ikke rekruttert ennå
- University of California, San Francisco
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Ta kontakt med:
- Jennifer Price, MD
- E-post: Jennifer.Price@ucsf.edu
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Hovedetterforsker:
- Jennifer Price, MD
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Har ikke rekruttert ennå
- University of Colorado Anschutz
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Ta kontakt med:
- Chia-Yu Chiu, MD
- E-post: chia-yu.chiu@cuanschutz.edu
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Hovedetterforsker:
- Chia-Yu Chiu, MD
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Har ikke rekruttert ennå
- Mayo Clinic, Florida
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Hovedetterforsker:
- Shennen Mao, MD
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Ta kontakt med:
- Shennen Mao, MD
- E-post: Mao.Shennen@mayo.edu
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Miami, Florida, Forente stater, 33136
- Har ikke rekruttert ennå
- University of Miami, Miami Transplant Institute
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Ta kontakt med:
- Jacques Simkins-Cohen, MD
- E-post: jsimkins@med.miami.edu
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Hovedetterforsker:
- Jacques Simkins-Cohen, MD
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Har ikke rekruttert ennå
- Emory University
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Ta kontakt med:
- William Kitchens, MD, PhD
- E-post: william.henry.kitchens.jr@emory.edu
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Hovedetterforsker:
- William Kitchens, MD, PhD
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Har ikke rekruttert ennå
- Northwestern University
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Ta kontakt med:
- Valentina Stosor, MD
- E-post: v-stosor@northwestern.edu
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Hovedetterforsker:
- Valentina Stosor, MD
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Louisiana
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Jefferson, Louisiana, Forente stater, 70121
- Har ikke rekruttert ennå
- Ochsner Clinic Foundation
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Ta kontakt med:
- Jonathan Hand, MD
- E-post: jonathan.hand@ochsner.org
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Hovedetterforsker:
- Jonathan Hand, MD
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Rekruttering
- Johns Hopkins University
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Hovedetterforsker:
- Christine Durand, MD
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Ta kontakt med:
- Christine Durand, MD
- E-post: ChristineDurand@jhmi.edu
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Har ikke rekruttert ennå
- Massachusetts General Hospital
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Hovedetterforsker:
- Nahel Elias, MD
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Ta kontakt med:
- Nahel Elias, MD
- E-post: Elias.Nahel@mgh.harvard.edu
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New York
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New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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Ta kontakt med:
- Sander Florman, MD
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Hovedetterforsker:
- Sander Florman, MD
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New York, New York, Forente stater, 10016
- Har ikke rekruttert ennå
- New York University School of Medicine
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Hovedetterforsker:
- Sapna Mehta, MD
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Ta kontakt med:
- Sapna Mehta, MD
- E-post: Sapna.Mehta@nyulangone.org
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New York, New York, Forente stater, 10065
- Har ikke rekruttert ennå
- Weill Cornell Medical College
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Hovedetterforsker:
- Catherine B Small, MD
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Ta kontakt med:
- Catherine B Small, MD
- E-post: cbs9003@med.cornell.edu
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Ohio
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Cincinnati, Ohio, Forente stater, 45229
- Har ikke rekruttert ennå
- University of Cincinnati
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Hovedetterforsker:
- Senu Apewokin, MD
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Ta kontakt med:
- Senu Apewokin, MD
- E-post: apewoksu@ucmail.uc.edu
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Columbus, Ohio, Forente stater, 43210
- Har ikke rekruttert ennå
- Ohio State University Medical Center
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Ta kontakt med:
- Nicholas Marschalk, DO
- E-post: Nicholas.Marschalk@osumc.edu
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Hovedetterforsker:
- Nicholas Marschalk, DO
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15224
- Har ikke rekruttert ennå
- University of Pittsburgh Medical Center
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Hovedetterforsker:
- Ghady Haidar, MD
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Ta kontakt med:
- Ghady Haidar, MD
- E-post: haidarg@upmc.edu
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Texas
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Dallas, Texas, Forente stater, 75390
- Har ikke rekruttert ennå
- University of Texas Southwestern Medical Center
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Ta kontakt med:
- David Wojciechowski, DO
- E-post: David.Wojciechowski@UTSouthwestern.edu
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Hovedetterforsker:
- David Wojciechowski, DO
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Houston, Texas, Forente stater, 77030
- Har ikke rekruttert ennå
- Houston Methodist Research Institute
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Ta kontakt med:
- Masayuki Nigo, MD MSc
- E-post: mnigo@houstonmethodist.org
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Hovedetterforsker:
- Masayuki Nigo, MD, MSc
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HIV D+/R+
People living with HIV who receive livers from deceased donors with HIV
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Receipt of liver transplant from a deceased donor with HIV
|
|
Eksperimentell: HIV D-/R+
People living with HIV who receive livers from deceased donors without HIV
|
Receipt of liver transplant from a deceased donor without HIV
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
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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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christine Durand, MD, Johns Hopkins University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. november 2026
Primær fullføring (Antatt)
1. august 2030
Studiet fullført (Antatt)
1. august 2031
Datoer for studieregistrering
Først innsendt
18. juni 2026
Først innsendt som oppfylte QC-kriteriene
18. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB00450882
- U01AI138897 (U.S. NIH-stipend/kontrakt)
- RTB-024 (Annen identifikator: The National Institute of Allergy and Infectious Diseases (NIAID))
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .