Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: HIV D+/R+, HIV D-/R+.
- Кому может быть актуально
- Состояния в реестре: HIV. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes
Обзор
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.
Подробное описание
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-).
Вмешательства
- Другое HIV D+/R+
Receipt of liver transplant from a deceased donor with HIV - Другое HIV D-/R+
Receipt of liver transplant from a deceased donor without HIV
Первичные конечные точки
- Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT [Срок оценки: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)]
Вторичные конечные точки (10)
- Participant survival [Срок оценки: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)]
- Graft survival [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)]
- Serious adverse events post-transplant [Срок оценки: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)]
- Incidence of rejection events post-transplant [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 19 центров
- Mayo Clinic, Arizona — Phoenix
- Cedars-Sinai Medical Center — Los Angeles
- University of California, San Francisco — San Francisco
- University of Colorado Anschutz — Aurora
- Mayo Clinic, Florida — Jacksonville
- University of Miami, Miami Transplant Institute — Miami
- Emory University — Atlanta
- Northwestern University — Chicago
- … и ещё 11 центров
Идентификаторы
NCT: NCT07665372 · IRB00450882 · U01AI138897 · RTB-024