HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Cumulative incidence of death and allograft rejection.
研究概览
简要总结
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
详细描述
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-).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HIV D+/R+
People living with HIV who receive kidneys from deceased donors with HIV
干预措施: HIV D+/R+ (Other)
HIV D-/R+
People living with HIV who receive kidneys from deceased donors without HIV
干预措施: HIV D-/R+ (Other)
结局指标
主要结局
Cumulative incidence of death and allograft rejection.
时间窗: From date of transplant to end of year 1
Proportion of participants who die or have graft rejection
次要结局
- Graft function over time measured by eGFR trajectory(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Type and severity of graft rejection(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Participant survival(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Rate of rejection events over time(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(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Time to first rejection(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Incidence of de novo donor specific antibody (DSA)(At month 12 post-transplant)
- Graft survival(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Incidence of HIV viremia post-transplant(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(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(In the first year post-transplant)
- Incidence of post-transplant malignancies(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))
- Incidence and causes of chronic kidney disease post-transplant(From transplant through end of follow up (at least 1 year, up to 4 years post-transplant))