NCT03500315已完成不适用
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 54
- 主要终点
- Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
研究概览
简要总结
The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.
详细描述
This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.
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 the standard criteria for kidney transplant at the local center.
- •Participant is able to understand and provide informed consent.
- •Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards.
- •Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).
- •Participant is ≥18 years old.
- •Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease.
- •Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.
- •HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements >200 copies/mL.
- •Participant is willing to comply with all medication related to their transplant and HIV management.
- •For participant with a history of aspergillus colonization or disease, no evidence of active disease.
- •The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management.
- •All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control.
- •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 a history of progressive multifocal leukoencephalopathy (PML) 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 or may impact the quality or interpretation of the data obtained from the study.
研究组 & 干预措施
HIV D-/R+
No Intervention
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100
HIV D+/R+
Experimental
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100
干预措施: HIV D+/R+ (Other)
HIV D-/R+ (observational)
No Intervention
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200
结局指标
主要结局
Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
时间窗: From date of transplant through administrative censorship at study completion, up to 4 years
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
Composite Event, Time to First Death or Graft Failure or Serious Adverse Event (SAE) or HIV Breakthrough or Opportunistic Infection
时间窗: From date of transplant through administrative censorship at study completion, up to 4 years
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
次要结局
- Pre-transplant mortality(From date of enrollment to date of transplant or death of any cause, whichever comes first, assessed up to 4 years)
- Rate of serious adverse events(From date of transplant through graft failure or administrative censorship at study completion, up to year 4)
- 6-month acute rejection(From date of transplant to end of month 6)
- Incidence of HIV-related renal disease(1 year post-transplant)
- Donor and recipient apolipoprotein L1 (APOL1)(Baseline)
- Trajectory of recipient plasma HIV RNA over time(From date of transplant through end of follow-up, up to 4 years)
- Graft failure(From date of transplant through administrative censorship at study completion, up to 4 years)
- Graft function -mean eGFR(3 months post-transplant)
- Graft function - Proportion eGFR <60 mL/min/1.73 m2(3 years post-transplant)
- 1-year acute rejection(From date of transplant to end of year 1)
- Incidence of graft rejection(From date of transplant through administrative censorship, up to 4 years)
- Incidence of non-HIV renal disease(1 year post-transplant)
- Composite event, time to first(From date of transplant through end of follow-up, up to 4 years)
- Graft function-mean eGFR(3 years post-transplant)
- Graft function - slope eGFR(From date of transplant to end of follow-up, up to 4 years)
- Incidence of viral-related malignancies(From date of transplant through end of follow-up, up to 4 years)
- HIV infection of renal allografts(6 months post-transplant)
- Trajectory of recipient Cluster of Differentiation (CD4) count over time(From date of transplant through end of follow up, up to 4 years)
- Incidence of antiretroviral resistance(From date of transplant through end of follow-up, up to 4 years)
- Incidence of surgical complications(From date of transplant through year 1)
- Incidence of vascular complications(From date of transplant through year 1)
- Incidence of X4 tropic virus(From date of transplant through end of follow-up, up to 4 years)
- Incidence of opportunistic infection(From date of transplant through end of follow-up, up to 4 years)
- Incidence of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies(From date of transplant through end of year 1)
- Pre-transplant Mortality(At 1 and 2 years post-consent, prior to transplant)
- Graft Failure(At 1 and 3 years post transplant)
- Rate of Serious Adverse Events(From date of transplant through graft failure or administrative censorship at study completion, up to year 4)
- 6-month Acute Rejection(At 6 months post-transplant)
- 1-year Acute Rejection(From date of transplant to end of year 1)
- Incidence of Graft Rejection(At 1 and 3 years post transplant)
- Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2(At 3 months post-transplant)
- Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2(At 6 months post-transplant)
- Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2(9 months post-transplant)
- Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2(At year 1 post-transplant)
- Graft Function Number of Participants With eGRF<60 mL/Min/1.73 m^2(At year 2 post-transplant)
- Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2(At year 3 post-transplant)
- Graft Function -Mean eGFR(3 months post-transplant)
- Graft Function-mean eGFR(6 months post-transplant)
- Graft Function-mean eGFR(9 months post-transplant)
- Graft Function-mean eGFR(1 year post-transplant)
- Graft Function-mean eGFR(2 years post-transplant)
- Graft Function-mean eGFR(3 years post-transplant)
- Graft Function - Slope eGFR(From date of transplant to end of follow-up, up to 4 years)
- Donor and Recipient Apolipoprotein L1 (APOL1)(Baseline)
- Participants With Undetectable HIV RNA(From date of transplant through end of follow-up, up to 4 years)
- Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time(From date of transplant through end of follow up, up to 4 years)
- Incidence of Antiretroviral Resistance(From date of transplant through end of follow-up, up to 4 years)
- Incidence of X4 Tropic Virus(From date of transplant through end of follow-up, up to 4 years)
- Incidence of Opportunistic Infection(From date of transplant through end of follow-up, up to 4 years)
- Incidence of Surgical Complications(From date of transplant through year 1)
- Incidence of Vascular Complications(From date of transplant through year 1)
- Incidence of Viral-related Malignancies(From date of transplant through end of follow-up, up to 4 years)
- Participants With Formation of de Novo Donor-specific Human Leukocyte Antigen(HLA) Antibodies(From date of transplant through end of year 1)
- Composite Event, Cumulative Incidence(At 6 months, 1 and 3 years post-transplant)
研究者
研究点 (54)
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