NCT02140944已完成不适用
IMPAACT P1107: Cord Blood Transplantation With CCR5Δ32 Donor Cells in HIV-1 Infected Subjects Who Require Bone Marrow Transplantation for Any Indication and Its Observed Effects on HIV-1 Persistence
International Maternal Pediatric Adolescent AIDS Clinical Trials Group1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年2月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older, who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer, hematopoietic disease, or other underlying disease.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV-1 infection
- •12 months of age or older
- •Willing to provide written informed consent
- •Pre-Transplant Cohort: Underlying disease appropriate for stem cell transplant, as determined by the transplant team as part of standard of care.
- •Pre-Transplant Cohort: Availability of an appropriately matched (as determined by the transplant center) CCR5Δ32 cord blood unit (homozygous or heterozygous) and intention to proceed with transplantation. NOTE: Double cord transplants are allowed. If a double cord is used, at least one cord blood unit should be CCR5∆32 (homozygous or heterozygous).
- •Pre-Transplant Cohort: Received a CCR5Δ32 homozygous cord blood or bone marrow transplant within the last two years.
排除标准
- •Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.
结局指标
主要结局
Survival
时间窗: Through 5 years post-transplant
Survival and event-free survival at 100 days, Week 26, Week 52, and then every six months until five years post-transplant
Graft versus host disease
时间窗: Through 5 years post-transplant
Graft versus host disease
Engraftment
时间窗: Through 5 years post-transplant
Chimerism (≥ 98% of blood cells bearing CCR5∆32) and time to hematopoietic cell and immune recovery
HIV DNA level
时间窗: Through 5 years post-transplant
HIV-1 proviral DNA levels in peripheral blood
次要结局
未报告次要终点
研究者
研究点 (1)
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