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

2026年9月8日 更新者: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.

研究概览

地位

招聘中

详细说明

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-).

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:HIV D+/R+
People living with HIV who receive livers from deceased donors with HIV
Receipt of liver transplant from a deceased donor with HIV
实验性的: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Participant survival
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Christine Durand, MD、Johns Hopkins University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2030年8月1日

研究完成 (估计的)

2031年8月1日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00450882
  • U01AI138897 (美国 NIH 拨款/合同)
  • RTB-024 (其他标识符:The National Institute of Allergy and Infectious Diseases (NIAID))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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