Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)
HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes
研究概览
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Christine Durand, MD
- 电话号码:410-614-6702
- 邮箱:ChristineDurand@jhmi.edu
学习地点
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Arizona
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Phoenix、Arizona、美国、85054
- 尚未招聘
- Mayo Clinic, Arizona
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接触:
- Andrew Singer, MD, PhD
- 邮箱:Singer.Andrew@mayo.edu
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首席研究员:
- Andrew Singer, MD, PhD
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California
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Los Angeles、California、美国、90048
- 尚未招聘
- Cedars-Sinai Medical Center
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接触:
- Nicholas Nissen, MD
- 邮箱:Nicholas.Nissen@cshs.org
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首席研究员:
- Nicholas Nissen, MD
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San Francisco、California、美国、94143
- 尚未招聘
- University of California, San Francisco
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接触:
- Jennifer Price, MD
- 邮箱:Jennifer.Price@ucsf.edu
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首席研究员:
- Jennifer Price, MD
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Colorado
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Aurora、Colorado、美国、80045
- 尚未招聘
- University of Colorado Anschutz
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接触:
- Chia-Yu Chiu, MD
- 邮箱:chia-yu.chiu@cuanschutz.edu
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首席研究员:
- Chia-Yu Chiu, MD
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Florida
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Jacksonville、Florida、美国、32224
- 尚未招聘
- Mayo Clinic, Florida
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首席研究员:
- Shennen Mao, MD
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接触:
- Shennen Mao, MD
- 邮箱:Mao.Shennen@mayo.edu
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Miami、Florida、美国、33136
- 尚未招聘
- University of Miami, Miami Transplant Institute
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接触:
- Jacques Simkins-Cohen, MD
- 邮箱:jsimkins@med.miami.edu
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首席研究员:
- Jacques Simkins-Cohen, MD
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Georgia
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Atlanta、Georgia、美国、30322
- 尚未招聘
- Emory University
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接触:
- William Kitchens, MD, PhD
- 邮箱:william.henry.kitchens.jr@emory.edu
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首席研究员:
- William Kitchens, MD, PhD
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Illinois
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Chicago、Illinois、美国、60611
- 尚未招聘
- Northwestern University
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接触:
- Valentina Stosor, MD
- 邮箱:v-stosor@northwestern.edu
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首席研究员:
- Valentina Stosor, MD
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Louisiana
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Jefferson、Louisiana、美国、70121
- 尚未招聘
- Ochsner Clinic Foundation
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接触:
- Jonathan Hand, MD
- 邮箱:jonathan.hand@ochsner.org
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首席研究员:
- Jonathan Hand, MD
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Maryland
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Baltimore、Maryland、美国、21205
- 招聘中
- Johns Hopkins University
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首席研究员:
- Christine Durand, MD
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接触:
- Christine Durand, MD
- 邮箱:ChristineDurand@jhmi.edu
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Massachusetts
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Boston、Massachusetts、美国、02114
- 尚未招聘
- Massachusetts General Hospital
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首席研究员:
- Nahel Elias, MD
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接触:
- Nahel Elias, MD
- 邮箱:Elias.Nahel@mgh.harvard.edu
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New York
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New York、New York、美国、10029
- 招聘中
- Icahn School of Medicine at Mount Sinai
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接触:
- Sander Florman, MD
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首席研究员:
- Sander Florman, MD
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New York、New York、美国、10016
- 尚未招聘
- New York University School of Medicine
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首席研究员:
- Sapna Mehta, MD
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接触:
- Sapna Mehta, MD
- 邮箱:Sapna.Mehta@nyulangone.org
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New York、New York、美国、10065
- 尚未招聘
- Weill Cornell Medical College
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首席研究员:
- Catherine B Small, MD
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接触:
- Catherine B Small, MD
- 邮箱:cbs9003@med.cornell.edu
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Ohio
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Cincinnati、Ohio、美国、45229
- 尚未招聘
- University of Cincinnati
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首席研究员:
- Senu Apewokin, MD
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接触:
- Senu Apewokin, MD
- 邮箱:apewoksu@ucmail.uc.edu
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Columbus、Ohio、美国、43210
- 尚未招聘
- Ohio State University Medical Center
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接触:
- Nicholas Marschalk, DO
- 邮箱:Nicholas.Marschalk@osumc.edu
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首席研究员:
- Nicholas Marschalk, DO
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15224
- 尚未招聘
- University of Pittsburgh Medical Center
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首席研究员:
- Ghady Haidar, MD
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接触:
- Ghady Haidar, MD
- 邮箱:haidarg@upmc.edu
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Texas
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Dallas、Texas、美国、75390
- 尚未招聘
- University of Texas Southwestern Medical Center
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接触:
- David Wojciechowski, DO
- 邮箱:David.Wojciechowski@UTSouthwestern.edu
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首席研究员:
- David Wojciechowski, DO
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Houston、Texas、美国、77030
- 尚未招聘
- Houston Methodist Research Institute
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接触:
- Masayuki Nigo, MD MSc
- 邮箱:mnigo@houstonmethodist.org
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首席研究员:
- Masayuki Nigo, MD, MSc
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
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Receipt of liver transplant from a deceased donor with HIV
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实验性的:HIV D-/R+
People living with HIV who receive livers from deceased donors without HIV
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Receipt of liver transplant from a deceased donor without HIV
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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)
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Cumulative incidence of composite event of opportunistic infection or cancer
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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 |
|---|---|---|
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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)
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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)
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From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
|
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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
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From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
|
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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)
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Cumulative incidence of cancer determined by local pathology
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From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
|
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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)
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Cumulative incidence of serious adverse events
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From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
|
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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)
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Cumulative incidence of rejection events
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From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
|
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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
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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
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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)
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Cumulative incidence of new resistance and/or X4 tropic virus based on local testing
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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
大体时间:From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
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Cumulative incidence of complications
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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
调查人员
- 首席研究员:Christine Durand, MD、Johns Hopkins University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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))
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