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
調査の概要
詳細な説明
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-).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Christine Durand, MD
- 電話番号:410-614-6702
- メール:ChristineDurand@jhmi.edu
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85054
- まだ募集していません
- Mayo Clinic, Arizona
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コンタクト:
- Andrew Singer, MD, PhD
- メール:Singer.Andrew@mayo.edu
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主任研究者:
- Andrew Singer, MD, PhD
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California
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Los Angeles、California、アメリカ、90048
- まだ募集していません
- Cedars-Sinai Medical Center
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コンタクト:
- Nicholas Nissen, MD
- メール:Nicholas.Nissen@cshs.org
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主任研究者:
- Nicholas Nissen, MD
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San Francisco、California、アメリカ、94143
- まだ募集していません
- University of California, San Francisco
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コンタクト:
- Jennifer Price, MD
- メール:Jennifer.Price@ucsf.edu
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主任研究者:
- Jennifer Price, MD
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Colorado
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Aurora、Colorado、アメリカ、80045
- まだ募集していません
- University of Colorado Anschutz
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コンタクト:
- Chia-Yu Chiu, MD
- メール:chia-yu.chiu@cuanschutz.edu
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主任研究者:
- Chia-Yu Chiu, MD
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Florida
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Jacksonville、Florida、アメリカ、32224
- まだ募集していません
- Mayo Clinic, Florida
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主任研究者:
- Shennen Mao, MD
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コンタクト:
- Shennen Mao, MD
- メール:Mao.Shennen@mayo.edu
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Miami、Florida、アメリカ、33136
- まだ募集していません
- University of Miami, Miami Transplant Institute
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コンタクト:
- Jacques Simkins-Cohen, MD
- メール:jsimkins@med.miami.edu
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主任研究者:
- Jacques Simkins-Cohen, MD
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Georgia
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Atlanta、Georgia、アメリカ、30322
- まだ募集していません
- Emory University
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コンタクト:
- William Kitchens, MD, PhD
- メール:william.henry.kitchens.jr@emory.edu
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主任研究者:
- William Kitchens, MD, PhD
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Illinois
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Chicago、Illinois、アメリカ、60611
- まだ募集していません
- Northwestern University
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コンタクト:
- Valentina Stosor, MD
- メール:v-stosor@northwestern.edu
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主任研究者:
- Valentina Stosor, MD
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Louisiana
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Jefferson、Louisiana、アメリカ、70121
- まだ募集していません
- Ochsner Clinic Foundation
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コンタクト:
- Jonathan Hand, MD
- メール:jonathan.hand@ochsner.org
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主任研究者:
- Jonathan Hand, MD
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Maryland
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Baltimore、Maryland、アメリカ、21205
- 募集
- Johns Hopkins University
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主任研究者:
- Christine Durand, MD
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コンタクト:
- Christine Durand, MD
- メール:ChristineDurand@jhmi.edu
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- まだ募集していません
- Massachusetts General Hospital
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主任研究者:
- Nahel Elias, MD
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コンタクト:
- Nahel Elias, MD
- メール:Elias.Nahel@mgh.harvard.edu
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New York
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New York、New York、アメリカ、10029
- 募集
- Icahn School of Medicine at Mount Sinai
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コンタクト:
- Sander Florman, MD
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主任研究者:
- Sander Florman, MD
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New York、New York、アメリカ、10016
- まだ募集していません
- New York University School of Medicine
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主任研究者:
- Sapna Mehta, MD
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コンタクト:
- Sapna Mehta, MD
- メール:Sapna.Mehta@nyulangone.org
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New York、New York、アメリカ、10065
- まだ募集していません
- Weill Cornell Medical College
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主任研究者:
- Catherine B Small, MD
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コンタクト:
- Catherine B Small, MD
- メール:cbs9003@med.cornell.edu
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Ohio
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Cincinnati、Ohio、アメリカ、45229
- まだ募集していません
- University of Cincinnati
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主任研究者:
- Senu Apewokin, MD
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コンタクト:
- Senu Apewokin, MD
- メール:apewoksu@ucmail.uc.edu
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Columbus、Ohio、アメリカ、43210
- まだ募集していません
- Ohio State University Medical Center
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コンタクト:
- Nicholas Marschalk, DO
- メール:Nicholas.Marschalk@osumc.edu
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主任研究者:
- Nicholas Marschalk, DO
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15224
- まだ募集していません
- University of Pittsburgh Medical Center
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主任研究者:
- Ghady Haidar, MD
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コンタクト:
- Ghady Haidar, MD
- メール:haidarg@upmc.edu
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Texas
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Dallas、Texas、アメリカ、75390
- まだ募集していません
- University of Texas Southwestern Medical Center
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コンタクト:
- David Wojciechowski, DO
- メール:David.Wojciechowski@UTSouthwestern.edu
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主任研究者:
- David Wojciechowski, DO
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Houston、Texas、アメリカ、77030
- まだ募集していません
- Houston Methodist Research Institute
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コンタクト:
- Masayuki Nigo, MD MSc
- メール:mnigo@houstonmethodist.org
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主任研究者:
- Masayuki Nigo, MD, MSc
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
時間枠: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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant survival
時間枠:From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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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)
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Graft survival
時間枠:From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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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
時間枠:From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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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
時間枠: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
時間枠: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
時間枠: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
時間枠:From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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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)
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Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant
時間枠:From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
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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)
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Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant
時間枠: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
時間枠: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)
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Christine Durand, MD、Johns Hopkins University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00450882
- U01AI138897 (米国 NIH グラント/契約)
- RTB-024 (その他の識別子:The National Institute of Allergy and Infectious Diseases (NIAID))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。