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

8 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Aún no reclutando
        • Mayo Clinic, Arizona
        • Contacto:
        • Investigador principal:
          • Andrew Singer, MD, PhD
    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Aún no reclutando
        • Cedars-Sinai Medical Center
        • Contacto:
        • Investigador principal:
          • Nicholas Nissen, MD
      • San Francisco, California, Estados Unidos, 94143
        • Aún no reclutando
        • University of California, San Francisco
        • Contacto:
        • Investigador principal:
          • Jennifer Price, MD
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Aún no reclutando
        • University of Colorado Anschutz
        • Contacto:
        • Investigador principal:
          • Chia-Yu Chiu, MD
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Aún no reclutando
        • Mayo Clinic, Florida
        • Investigador principal:
          • Shennen Mao, MD
        • Contacto:
      • Miami, Florida, Estados Unidos, 33136
        • Aún no reclutando
        • University of Miami, Miami Transplant Institute
        • Contacto:
        • Investigador principal:
          • Jacques Simkins-Cohen, MD
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Aún no reclutando
        • Emory University
        • Contacto:
        • Investigador principal:
          • William Kitchens, MD, PhD
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Aún no reclutando
        • Northwestern University
        • Contacto:
        • Investigador principal:
          • Valentina Stosor, MD
    • Louisiana
      • Jefferson, Louisiana, Estados Unidos, 70121
        • Aún no reclutando
        • Ochsner Clinic Foundation
        • Contacto:
        • Investigador principal:
          • Jonathan Hand, MD
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Reclutamiento
        • Johns Hopkins University
        • Investigador principal:
          • Christine Durand, MD
        • Contacto:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Aún no reclutando
        • Massachusetts General Hospital
        • Investigador principal:
          • Nahel Elias, MD
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10029
        • Reclutamiento
        • Icahn School of Medicine at Mount Sinai
        • Contacto:
          • Sander Florman, MD
        • Investigador principal:
          • Sander Florman, MD
      • New York, New York, Estados Unidos, 10016
        • Aún no reclutando
        • New York University School of Medicine
        • Investigador principal:
          • Sapna Mehta, MD
        • Contacto:
      • New York, New York, Estados Unidos, 10065
        • Aún no reclutando
        • Weill Cornell Medical College
        • Investigador principal:
          • Catherine B Small, MD
        • Contacto:
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Aún no reclutando
        • University of Cincinnati
        • Investigador principal:
          • Senu Apewokin, MD
        • Contacto:
      • Columbus, Ohio, Estados Unidos, 43210
        • Aún no reclutando
        • Ohio State University Medical Center
        • Contacto:
        • Investigador principal:
          • Nicholas Marschalk, DO
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Aún no reclutando
        • University of Pittsburgh Medical Center
        • Investigador principal:
          • Ghady Haidar, MD
        • Contacto:
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • Aún no reclutando
        • University of Texas Southwestern Medical Center
        • Contacto:
        • Investigador principal:
          • David Wojciechowski, DO
      • Houston, Texas, Estados Unidos, 77030
        • Aún no reclutando
        • Houston Methodist Research Institute
        • Contacto:
        • Investigador principal:
          • Masayuki Nigo, MD, MSc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HIV D+/R+
People living with HIV who receive livers from deceased donors with HIV
Otro: HIV D+/R+
Receipt of liver transplant from a deceased donor with HIV
Experimental: HIV D-/R+
People living with HIV who receive livers from deceased donors without HIV
Otro: HIV D-/R+
Receipt of liver transplant from a deceased donor without HIV

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant survival
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Johns Hopkins University

Colaboradores

National Institute of Allergy and Infectious Diseases (NIAID)

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de agosto de 2030

Finalización del estudio (Estimado)

1 de agosto de 2031

Fechas de registro del estudio

Enviado por primera vez

18 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB00450882
  • U01AI138897 (Subvención/contrato del NIH de EE. UU.)
  • RTB-024 (Otro identificador: The National Institute of Allergy and Infectious Diseases (NIAID))

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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