Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
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 Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
Обзор
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs 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 their 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 their HIV. This study will look to better understand rejection in transplant recipients with HIV (HIVR+) who receive kidneys from donors with HIV (HIVD+) vs without HIV (HIVD-).
Вмешательства
- Другое HIV D+/R+
Receipt of kidney transplant from a deceased donor with HIV. - Другое HIV D-/R+
Receipt of kidney transplant from a deceased donor without HIV.
Первичные конечные точки
- Cumulative incidence of death and allograft rejection. [Срок оценки: From date of transplant to end of year 1]
Вторичные конечные точки (12)
- Participant survival [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Graft survival [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Type and severity of graft rejection [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Time to first rejection [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Rate of rejection events over time [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Graft function over time measured by eGFR trajectory [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of HIV viremia post-transplant [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of surgical and vascular transplant complications post-transplant [Срок оценки: In the first year post-transplant]
- Incidence and causes of chronic kidney disease post-transplant [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of post-transplant malignancies [Срок оценки: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
Критерии участия
Критерии включения
- Participant meets local criteria for kidney transplant.
- Participant 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.
- HIV-1 RNA < 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL.
- Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.
Критерии исключения
- Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month, or 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 · 18 центров
- University of Alabama at Birmingham — Birmingham
- University of California, Davis — Sacramento
- University of California, San Diego — San Diego
- University of California, San Francisco — San Francisco
- Mayo Clinic Florida — Jacksonville
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
- Ochsner Clinic Foundation — New Orleans
- … и ещё 10 центров
Идентификаторы
NCT: NCT06263426 · IRB00387066 · U01AI177211