NCT02732457终止不适用
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
研究概览
简要总结
The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.
详细描述
- To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally.
- To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue.
- To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells.
- To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.
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
- •HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
- •Over 18 years of age
- •Provision of written, informed consent
排除标准
- •In the opinion of the investigator that the patient is not able to provide informed consent
- •Hb < 9 (g/dL)
- •CD4+ T cell count <100 (cells/µl)
- •Serious coagulation abnormalities, platelet count <
- •Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)
- •History of allergy to local anaesthetics
- •Pregnancy
结局指标
主要结局
Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
时间窗: 3 years
HIV-1 DNA in CD4+ T cells will be measured by real-time PCR and reported as HIV-1 DNA copies in 10e6 CD4+ T cells
次要结局
- Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot(3 years)
研究者
研究点 (1)
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