NCT03734393已完成不适用
HOPE in Action Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
Johns Hopkins University51 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 51
- 主要终点
- Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure
研究概览
简要总结
The primary objective of this study is to determine if an HIV-infected donor liver (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 liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a liver from an HIV-uninfected deceased liver 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
- 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 liver transplant at the local center.
- •Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs.
- •Participant is able to understand and provide informed consent.
- •Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria.
- •Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).*
- •Participant is ≥ 18 years old.
- •Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.
- •CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present.
- •HIV-1 RNA is below 50 RNA/mL.* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. *Organ recipients who are unable to tolerate anti-retroviral therapy (ART) due to organ.
- •failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
- •Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.
- •Participant is willing to comply with all medications related to participant's transplant and HIV management.
- •For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease.
- •Agreement to use contraception.
- •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. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)
- •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
HIVD-/R+ (observational)
No Intervention
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120
HIV D+/R+
Experimental
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40
干预措施: HIVD+/R+ (Other)
HIVD-/R+
No Intervention
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and are randomized to participate in the full study arm, which includes research sample collection -enrollment 40
结局指标
主要结局
Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure
时间窗: From date of transplant through administrative censorship at study completion, up to 4 years
Time (in days) to first of any of the following events: death or graft failure or SAE or HIV breakthrough or opportunistic infection
次要结局
- 3-year acute liver rejection(From date of transplant to end of year 3)
- Number of Non-alcoholic fatty liver (NAFL)(From date of transplant through end of follow-up, up to 3 years)
- Trajectory of recipient Cluster of Differentiation (CD4) count over time(From date of transplant through end of follow up, up to 4 years)
- 2-year acute liver rejection(From date of transplant to end of year 2)
- Number of graft rejections in liver transplant(From date of transplant to end of year 3)
- Graft Failure as assessed by Time to first occurrence of mortality or re-transplant or return to maintenance dialysis(From date of transplant through administrative censorship at study completion, up to 4 years)
- 1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only(From date of transplant to end of year 1)
- Trajectory of recipient plasma HIV RNA over time(From date of transplant through end of follow-up, up to 4 years)
- Time to Pre-transplant mortality(From date of enrollment to date of transplant or death of any cause, whichever comes first, assessed up to 4 years)
- Average graft function as assessed by aspartate aminotransferase (AST)(1 year post-transplant)
- Graft function as assessed by Fibrosis-4 index(4 years post-transplant)
- Average graft function as assessed by AST(4 years post-transplant)
- 1-year acute liver rejection(From date of transplant to end of year 1)
- Number of steatohepatitis (NASH)(From date of transplant through end of follow-up, up to 3 years)
- Graft function as assessed by liver stiffness(3 years post-transplant)
- Average graft function as assessed by alanine aminotransferase (ALT)(1 year post-transplant)
- Average graft function as assessed by bilirubin(3 years post-transplant)
- Number of surgical complications(From date of transplant through year 1)
- 6-month acute kidney rejection in simultaneous liver/kidney transplant recipients(From date of transplant to 6 months post transplant)
- Graft function as assessed by incidence of fibrosis(From date of transplant through end of follow-up, up to 3 years)
- Average hemoglobin a1c among participants at 3 years(3 years post-transplant)
- Number of opportunistic infections(From date of transplant through end of follow-up, up to 4 years)
- Graft function as assessed by Mean calculated Model for End Stage Liver Disease (MELD) score(1 year post-transplant)
- Average hemoglobin a1c among participants at 4 years(4 years post-transplant)
- Hepatitis C (HCV) sustained viral response post-transplant(12 weeks HCV treatment)
- Average Graft function as assessed by ALT(3 years post-transplant)
- Average graft function as assessed by Bilirubin(4 years post-transplant)
- Average graft function as assessed by ALT(4 years post-transplant)
- Graft function as assessed by AST to Platelet Ratio (APRI) index(4 years post-transplant)
- Average hemoglobin a1c among participants at 1 year(1 years post-transplant)
- Average hemoglobin a1c among participants at 2 years(2 years post-transplant)
- Number of X4 tropic virus breakthroughs(From date of transplant through end of follow-up, up to 4 years)
- Time to first occurrence of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness as a composite measure(From date of transplant through end of follow-up, up to 4 years)
- Graft function as assessed by Mean calculated MELD score(4 years post-transplant)
- Metabolic Outcome as assessed by Body mass index (BMI)(4 years post-transplant)
- Number of HIV breakthroughs(From date of transplant through end of follow-up, up to 4 years)
- Number of vascular complications(From date of transplant through year 1)
- Number of viral-related malignancies(From date of transplant through end of follow-up, up to 4 years)
- Number of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies(From date of transplant through end of year 1)
- Graft function as assessed by Fibrosis-4 index(1 years post-transplant)
- Graft function as assessed by Fibrosis-4 index(2 years post-transplant)
- Graft function as assessed by Fibrosis-4 index(3 years post-transplant)
- Graft function as assessed by liver stiffness(1 year post-transplant)
- Graft function as assessed by liver stiffness(2 years post-transplant)
- Average graft function as assessed by AST(2 years post-transplant)
- Average graft function as assessed by AST(3 years post-transplant)
- Average graft function as assessed by ALT(2 years post-transplant)
- Average graft function as assessed by bilirubin(1 year post-transplant)
- Average graft function as assessed by bilirubin(2 years post-transplant)
- Graft function as assessed by Mean calculated MELD score(2 years post-transplant)
- Graft function as assessed by Mean calculated MELD score(3 years post-transplant)
- Graft function as assessed by AST to Platelet Ratio (APRI) index(1 year post-transplant)
- Graft function as assessed by AST to Platelet Ratio (APRI) index(2 years post-transplant)
- Graft function as assessed by AST to Platelet Ratio (APRI) index(3 years post-transplant)
- Metabolic Outcome as assessed by Body mass index (BMI)(1 year post-transplant)
- Metabolic Outcome as assessed by Body mass index (BMI)(2 years post-transplant)
- Metabolic Outcome as assessed by Body mass index (BMI)(3 years post-transplant)
研究者
研究点 (51)
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