NCT02602262已完成不适用
Observational Study of HIV+ Deceased Donor Solid Organ Transplant for HIV+ Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 18
- 主要终点
- Survival
研究概览
简要总结
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed.
详细描述
This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate overall survival and graft survival compared to transplantation with an HIV- organ.
In addition the study will assess potential complications of organ transplant using HIV+ deceased donors - including but not limited to - HIV superinfection, incidence and severity of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial infections, and opportunistic infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
- •Participant is able to understand and provide informed consent
- •Participant meets standard listing criteria for transplant.
- •Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable HIV-1 RNA).
- •Participant is > 18 years old.
- •Opportunistic Complications: None or previous history of protocol allowed opportunistic infections or neoplasms with appropriate acute and maintenance therapy and no evidence of active disease.
- •Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.
- •Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL) should be < 50 copies, but this result can be documented outside the 16 week window according to the judgement of the local clinical team and site investigator. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen to be used by the recipient once organ function is restored after transplantation.
- •Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.
排除标准
- •Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
- •Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary Central Nervous System (CNS) lymphoma.
- •Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease free state for 2 years. History of leukemia and disease-free duration will be per site policy.
- •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 clinical practice. Women that become pregnant should not breastfeed.
结局指标
主要结局
Survival
时间窗: One year
Patient survival at one year
次要结局
- Graft rejection(One year)
- HIV disease progression(through study completion, up to 4 years)
- Surgical complications(within the first 3 months)
- Incidence of bacterial, fungal, viral, and other opportunistic infection(through study completion, up to 4 years)
- Incidence of post-transplant Malignancy(through study completion, up to 4 years)
- Immune activation(measured at 3 months, 6 months, year 1, year 2, year 3, year 4)
- Graft survival(one year, two years, 3 years, 4 years)
- Incidence of HIV superinfection in blood and/or tissue(measured at 3 months, 6 months, year 1, year 2, year 3, year 4)
- Antiretroviral resistance and X4 tropic virus(through study completion, up to 4 years)
- HIV latent reservoir(measured at 3 months, 6 months, year 1, year 2, year 3, year 4)
- Recurrent HIV-associated nephropathy(through study completion, up to 4 years)
研究者
研究点 (18)
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