NCT03408106已完成不适用
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
详细描述
This is a prospective study to evaluate the safety of donor nephrectomy in HIV+ individuals who donate kidneys to HIV+ candidates in need of transplant . The study will assess potential complications of HIV + living donors - including adverse events related to nephrectomy, development of chronic kidney disease, hypertension, and HIV-related complications.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide consent
- •Age 21 years or older
- •Meets standard clinical criteria for living donation per Johns Hopkins University (JHU) Comprehensive Transplant Center Policy
- •Documented HIV infection (by any licensed Enzyme-linked Immunosorbent Assay (ELISA) and confirmation by Western Blot, positive HIV Ab Immunofluorescent Assay (IFA), or documented history of detectable HIV-1 RNA)
- •CD4+ T-cell count ≥ 500/µL for 6 months prior to donation
- •HIV-1 RNA below 50 copies RNA/mL (viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements >200 copies/mL)
排除标准
- •Two high risk alleles of APOL1 (G1 or G2 variants)
- •Hypertension
- •Chronic active hepatitis C (detectable HCV RNA in plasma)
- •Evidence of invasive opportunistic complications from HIV infection
- •Mentally incompetent and/or inability to provide informed consent
- •Other medical conditions, as determined by the provider, that would preclude donation
结局指标
主要结局
Adverse events
时间窗: at 1 year
incidence of adverse events related to nephrectomy
次要结局
- change in antiretroviral therapy(through to study completion, up to 4 years)
- hypertension(through to study completion, up to 4 years)
- chronic kidney disease(through to study completion, up to 4 years)
- HIV virologic control(through to study completion, up to 4 years)
研究者
研究点 (2)
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