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:
- 金额:$ 336.64万
- 依托单位:
- 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:
- 关键词:APOL1 geneAcquired Immunodeficiency SyndromeAgeAllograftingAnti-HIV AgentsAntibodiesAntiretroviral resistanceAntithymoglobulinBiologicalBiometryBiopsyBloodCD4 Lymphocyte CountCase Report FormCell CountCessation of lifeClinicalClinical TrialsCommunicable DiseasesCommunitiesConsentDatabasesDevelopmentDiseaseDonor personDrug resistanceEffectivenessElectron MicroscopyEnd stage renal failureEnrollmentEnsureEpidemiologyEventFailureFundingFutureGenderGeneticGenetic RiskGraft RejectionGrantHIVHealth BenefitImmuneImmunofluorescence MicroscopyImmunosuppressive AgentsIncidenceIndividualInfectionInfrastructureKidneyKidney DiseasesKidney TransplantationKnowledgeLeadMalignant NeoplasmsMeasuresMediatingMulti-Institutional Clinical TrialMulticenter StudiesNational Institute of Allergy and Infectious DiseaseNephrologyOpportunistic InfectionsOrganOrgan DonorOrgan ProcurementsOutcomeParticipantPathogenesisPathologicPathologyPatientsPharmaceutical PreparationsPilot ProjectsPoliciesPopulationPrevalenceProtocols documentationPublic HealthRaceResearchResistanceResourcesRiskSafety ManagementSavingsSeveritiesSirolimusSourceSouth AfricaSouth AfricanTestingTimeTissuesTransplant RecipientsTransplantationTransplantation SurgeryUnited Network for Organ SharingUnited States National Institutes of HealthVariantViralWait TimeWaiting Listsantiretroviral therapybiobankcohortcomorbiditydata managementdesigndetection assaydigital imagingdonor-specific antibodyexperiencefrailtygraft failurehealth care availabilityinterestliver transplantationliving kidney donormortalitynext generation sequencingnoveloperationpost-transplantprimary endpointprospectivepublic health relevancerecruitrepositorysafety and feasibilitysexsuperinfectiontransplant centerstrial designviral reboundvirologywhole 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:
- 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.
- DOI:10.1007/s40506-018-0144-1
- 发表时间:2018-03
- 期刊:
- 影响因子:2
- 作者:Shaffer AA;Durand CM
- 通讯作者:Durand CM
Donors with human immunodeficiency virus and hepatitis C virus for solid organ transplantation: what's new.
- DOI:10.1097/qco.0000000000000840
- 发表时间:2022-08-01
- 期刊:
- 影响因子:3.9
- 作者:
- 通讯作者:
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Christine Marie Durand其他文献
Christine Marie Durand的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Christine Marie Durand', 18)}}的其他基金
Kidney Transplantation from Donors with HIV: Impact on Rejection and Long-term Outcomes
艾滋病毒捐献者的肾移植:对排斥和长期结果的影响
- 批准号:
10704333 - 财政年份:2023
- 资助金额:
$ 336.64万 - 项目类别:
A Randomized Controlled Trial of Prophylaxis with Direct-acting Antivirals for Kidney Transplantation from Hepatitis C virus-infected donor to Uninfected Recipients (PREVENT-HCV)
直接作用抗病毒药物预防丙型肝炎病毒感染供者肾移植至未感染受者的随机对照试验 (PREVENT-HCV)
- 批准号:
10597168 - 财政年份:2022
- 资助金额:
$ 336.64万 - 项目类别:
A Randomized Controlled Trial of Prophylaxis with Direct-acting Antivirals for Kidney Transplantation from Hepatitis C virus-infected donor to Uninfected Recipients (PREVENT-HCV)
直接作用抗病毒药物预防丙型肝炎病毒感染供者肾移植至未感染受者的随机对照试验 (PREVENT-HCV)
- 批准号:
10405358 - 财政年份:2022
- 资助金额:
$ 336.64万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10492082 - 财政年份:2021
- 资助金额:
$ 336.64万 - 项目类别:
COVID Protection After Transplant (CPAT) Multicenter Adaptive Trial
移植后新冠肺炎保护 (CPAT) 多中心适应性试验
- 批准号:
10457200 - 财政年份:2021
- 资助金额:
$ 336.64万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10214504 - 财政年份:2018
- 资助金额:
$ 336.64万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
9753122 - 财政年份:2018
- 资助金额:
$ 336.64万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10459319 - 财政年份:2018
- 资助金额:
$ 336.64万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10622648 - 财政年份:2018
- 资助金额:
$ 336.64万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10681594 - 财政年份:2018
- 资助金额:
$ 336.64万 - 项目类别:
相似海外基金
RESEARCH SUPPORT SERVICES FOR THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME
获得性免疫缺陷综合症分类的研究支持服务
- 批准号:
10219039 - 财政年份:2020
- 资助金额:
$ 336.64万 - 项目类别:
RESEARCH SUPPORT SERVICES FOR THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME
获得性免疫缺陷综合症分类的研究支持服务
- 批准号:
9981476 - 财政年份:2019
- 资助金额:
$ 336.64万 - 项目类别:
IGF::OT::IGF RESEARCH SUPPORT SERVICES FOR THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME
IGF::OT::IGF 针对获得性免疫缺陷综合症分类的研究支持服务
- 批准号:
9364184 - 财政年份:2016
- 资助金额:
$ 336.64万 - 项目类别:
Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) in Saskatchewan- Where are we now and what does the future hold?
萨斯喀彻温省的人类免疫缺陷病毒(HIV)和获得性免疫缺陷综合症(艾滋病)——我们现在在哪里以及未来会怎样?
- 批准号:
236932 - 财政年份:2011
- 资助金额:
$ 336.64万 - 项目类别:
Miscellaneous Programs
ACQUIRED IMMUNODEFICIENCY SYNDROME RESEARCH REVIEW COMMI
获得性免疫缺陷综合症研究审查委员会
- 批准号:
3554155 - 财政年份:1991
- 资助金额:
$ 336.64万 - 项目类别:
ACQUIRED IMMUNODEFICIENCY SYNDROME RESEARCH REVIEW COMMI
获得性免疫缺陷综合症研究审查委员会
- 批准号:
3554156 - 财政年份:1991
- 资助金额:
$ 336.64万 - 项目类别:
ACQUIRED IMMUNODEFICIENCY SYNDROME RESEARCH REVIEW
获得性免疫缺陷综合症研究综述
- 批准号:
2063342 - 财政年份:1991
- 资助金额:
$ 336.64万 - 项目类别: