A Prospective Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Patient Survival
研究概览
简要总结
The primary objective of this study is to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients.
HIV-positive individuals who agree to accept and receive a solid organ transplant from and HIV-positive donor will be followed to determine the safety and efficacy of this practice.
详细描述
This is a prospective observational study of solid organ transplantation utilizing HIV-positive donors in HIV-positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney, liver) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney, liver) and living donors (liver) will be utilized in this protocol. No living kidney donors will be enrolled.
This study will evaluate overall survival and graft survival. In addition the study will assess potential complications of organ transplant using HIV+ donor organs, including but not limited to: HIV disease progression, development of antiretroviral resistance mutations, incidence of opportunistic infections, incidence of transplant complications, impacts of liver regeneration, incidence of viral-related malignancies, and incidence of HIV-superinfection.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Survival
时间窗: One Year
Patient survival at one year.
次要结局
- Incidence of other transplant complications (surgical and vascular)(Through study completion, up to three years)
- Incidence of bacterial, fungal, viral and other opportunistic infections(Through study completion, up to three years)
- HIV Disease Progression(Through study completion, up to three years)
- Incidence of tissue specific HIV-superinfection(Through study completion, up to three years)
- Liver transplant recipients: Impact on liver regeneration(Through study completion, up to three years)
- Incidence of systemic HIV-superinfection in blood(Through study completion, up to three years)
- Graft Survival(Months 3, 6, 9, Years 1, 2, 3)
- Incidence and Severity of Graft Rejection(Through study completion, up to three years)
- Development of antiretroviral resistance mutations and/or X4 tropic virus in blood and allograft(Through study completion, up to three years)
- Analysis of recurrent HIV associated nephropathy among kidney transplant recipients(Through study completion, up to three years)
- Incidence of other viral-related malignancies (HPV, EBV, HBV, HCV)(Through study completion, up to three years)