权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

HOPE in Action: A clinical trial of HIV-to-HIV deceased donor kidney transplantation

希望在行动：艾滋病毒转艾滋病毒死者供体肾移植的临床试验

基本信息

批准号：
10462020
负责人：
Christine Marie Durand
金额：
$ 336.64万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-31 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10462020
关键词：
APOL1 gene Acquired Immunodeficiency Syndrome Age Allografting Anti-HIV Agents Antibodies Antiretroviral resistance Antithymoglobulin Biological Biometry Biopsy Blood CD4 Lymphocyte Count Case Report Form Cell Count Cessation of life Clinical Clinical Trials Communicable Diseases Communities Consent Databases Development Disease Donor person Drug resistance Effectiveness Electron Microscopy End stage renal failure Enrollment Ensure Epidemiology Event Failure Funding Future Gender Genetic Genetic Risk Graft Rejection Grant HIV Health Benefit Immune Immunofluorescence Microscopy Immunosuppressive Agents Incidence Individual Infection Infrastructure Kidney Kidney Diseases Kidney Transplantation Knowledge Lead Malignant Neoplasms Measures Mediating Multi-Institutional Clinical Trial Multicenter Studies National Institute of Allergy and Infectious Disease Nephrology Opportunistic Infections Organ Organ Donor Organ Procurements Outcome Participant Pathogenesis Pathologic Pathology Patients Pharmaceutical Preparations Pilot Projects Policies Population Prevalence Protocols documentation Public Health Race Research Resistance Resources Risk Safety Management Savings Severities Sirolimus Source South Africa South African Testing Time Tissues Transplant Recipients Transplantation Transplantation Surgery United Network for Organ Sharing United States National Institutes of Health Variant Viral Wait Time Waiting Lists antiretroviral therapy biobank cohort comorbidity data management design detection assay digital imaging donor-specific antibody experience frailty graft failure health care availability interest liver transplantation living kidney donor mortality next generation sequencing novel operation post-transplant primary endpoint prospective public health relevance recruit repository safety and feasibility sex superinfection transplant centers trial design viral rebound virology whole slide imaging

项目摘要

There is a growing need for kidney transplantation in HIV-infected (HIV+) individuals as the prevalence of end- stage renal disease increases. Outcomes of transplant in HIV+ individuals with kidneys from HIV-uninfected (HIV-) donors are excellent. However, there is a profound organ shortage, with extremely long waiting times, and a higher waitlist mortality for HIV+ individuals in particular. Organs from HIV+ deceased donors (HIVD+) are a unique resource for HIV+ transplant candidates. By expanding the donor pool, use of organs from HIVD+ could have a significant public health impact and decrease wait times for everyone on the waitlist. This motivated the Congressional HOPE (HIV Organ Policy Equity) Act which now allows HIVD+ transplants for HIV+ recipients (R+) under research protocols. Potential risks of HIVD+ transplants include complications related to donor-to-recipient HIV superinfection (HIV-SI) and development of HIV-associated kidney disease after transplant. Preliminary experience with HIVD+ transplants in South Africa is encouraging, however, the experience cannot be generalized to the US due to population differences (race, age, sex, health care access), and disease differences (underlying kidney disease, HIV prevalence, subtype, opportunistic infections, access and resistance to antiretroviral therapy). To determine if HIVD+ kidney transplantation is safe and effective in the US, we propose HOPE in Action: A Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Kidney Transplants for HIV+ Recipients. We will compare transplant outcomes between HIV+ recipients who receive kidneys from HIV+ versus HIV- donors enrolling 80 in each group over 3 years at 16 transplant centers. Aim 1 is to compare differences in time to HIV-related complications and Aim 2 to compare incidence of HIV-related kidney disease. In Aim 3, we will characterize HIV-SI in blood and its association with clinical outcomes and in Aim 4 we will characterize changes in HIV reservoirs over time in participants receiving immunosuppressants of interest for HIV cure. Finally, establishment of a rich biorepository of tissue and blood from this unique cohort will provide an unprecedented opportunity for future mechanistic studies related to HIV persistence and pathogenesis. With support from NIAID (R34AI23023) over the past year, we have planned and designed the trial, assembling a team of experts in Transplant Surgery, HIV/Infectious Diseases, Nephrology, Epidemiology, Biostatistics, Pathology and Virology. We have partnered with the UNOS and OPTN in an ongoing study to identify and evaluate HIVD+ nationally (R01AI120938). In addition, we are coordinating a multicenter clinical pilot study and have performed the first-in-US HIVD+ kidney and liver transplants. The proposed clinical trial will determine whether the use of HIVD+ is safe and effective. If implemented, this practice could provide the largest expansion of the organ donor pool in the last decade, potentially saving thousands of lives of HIV+ and HIV-negative individuals.

随着艾滋病毒感染（HIV+）的流行，对肾移植的需求越来越大

项目成果

期刊论文数量（5）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Detectable plasma severe acute respiratory syndrome coronavirus 2 spike antigen is associated with poor antibody response following third messenger RNA vaccination in kidney transplant recipients.

在肾移植受者中，可检测到的血浆严重急性呼吸综合征冠状病毒 2 刺突抗原与第三信使 RNA 疫苗接种后抗体反应不佳有关。

DOI：
10.1111/tid.14281
发表时间：
2024
期刊：
Transplant infectious disease : an official journal of the Transplantation Society
影响因子：
0
作者：
Karaba,AndrewH;Swank,Zoe;Hussain,Sarah;Chahoud,Margaret;Durand,ChristineM;Segev,DorryL;Robien,MarkA;Heeger,PeterS;Larsen,ChristianP;Tobian,AaronAR;Walt,DavidR;Werbel,WilliamA
通讯作者：
Werbel,WilliamA

Solid Organ Transplantation for HIV-Infected Individuals.