A Phase I/II Study Of the Safety, Survival, and Trafficking of Autologous CD4-ZETA Gene-Modified T Cells With and Without Extension Interleukin-2 in HIV Infected Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART
研究概览
简要总结
The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).
详细描述
The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2). The treatments that the investigators are studying try to improve the immune system by changing some of your T cells so they can find and destroy HIV infected cells (HIV is usually able to hide from your T cells). In this study, the investigators are also trying to find out if giving you more IL-2 at the same time as gene changed T cells will help the T cells to live longer or fight HIV better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •DOD beneficiary with HIV-1 infection
- •Greater than or equal to 200 CD4 cells/mm3
- •Undetectable viral load, for at least the previous 8 weeks
- •Stable anti-retroviral regimen for greater than or equal to 8 weeks
- •Venous access sufficient for apheresis
- •Karnofsky performance > 80%
排除标准
- •Inadequate organ function
- •Lifetime history of CD4 count less than 200 cells/mm3 on 2 consecutive measurements over at least an 8 week period
- •Any previous history of gene therapy
- •Recent IL-2 therapy or other treatment with an investigational agent
- •Pregnancy
- •some medications (hydroxyurea, corticosteroids and other immunosuppressants, chemotherapy, etc.)
研究组 & 干预措施
ARM 1
Arm I (N=5) received antiretroviral therapy (ART) plus low dose IL-2 (1.2 million units/m2) subcutaneously daily for 56 days
干预措施: HAART (Drug)
ARM 2
Arm 2 (N=5) received ART plus a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.
干预措施: T cells (Biological)
ARM 3
Arm 3 (n=5) received ART plus IL-2 (1.2 million units/m2) and a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.
干预措施: HAART (Drug)
ARM 3
Arm 3 (n=5) received ART plus IL-2 (1.2 million units/m2) and a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.
干预措施: T cells (Biological)
结局指标
主要结局
Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART
时间窗: Through study completion, an average of 1 year
To assess and compare the safety of each arm when comparing related adverse events reported of subjects on study through the end of study (week 54).
To compare the viral load of subjects from baseline to the end of study.
时间窗: Through study completion, an average of 1 year
Determine the effect of CD4-zeta infusions with and without IL-2 on viral load (plasma HIV-1 RNA, tissue HIV-1 RNA, and frequency of latent replication-competent HIV-1 in PBMC) at study specific timepoints.
Effect of IL-2 on the Persistence of CD4-zeta T cells
时间窗: Through study completion, an average of 1 year
Subjects who received IL-2 plus gene-modified cells versus those who received cells alone will have greater numbers gene-modified cells in both PBMCs and rectal lymphoid tissue. This will be done by quantifying residual virus in the reservoir using more modern techniques that permit quantification of small amounts of virus in the rectal lymphoid tissue and to quantify specifically replication competent HIV (versus total HIV).
次要结局
未报告次要终点