Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Quantification of donor-derived HIV-1-specific immune responses following HCT
研究概览
简要总结
This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.
详细描述
PRIMARY OBJECTIVES:
I. Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients.
II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.
OUTLINE:
Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive
- •Treatment with highly active antiretroviral therapy (HAART) for at least 1 month
- •Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy
- •Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated
- •Approval for allogenic regimen given at Patient Care Conference
- •DONOR: Autologous or allogeneic gene modified cells allowed
排除标准
- •A medical history of noncompliance with HAART or medical therapy
- •Inability to provide informed consent
- •DONOR: Allogeneic donors must not have HIV infection
结局指标
主要结局
Quantification of donor-derived HIV-1-specific immune responses following HCT
时间窗: Up to 1 year
HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
Quantification of latently infected CD4+ cells in HIV+ patients
时间窗: Up to 7 years
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.
次要结局
未报告次要终点