Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients
Procedure for Initiation, Administration, and Discontinuation of Interleukin-2 (IL-2) Therapy in Conjunction With Highly Active Antiretroviral Therapy
The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection.
IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.
研究概览
详细说明
At the time of initial HIV infection, CD4 cells are susceptible to infection, and the virus infects many T cells during the first 4 to 6 weeks. Many of these infected cells subsequently maintain the virus in a latent state. Immune reconstitution with daily low-dose IL-2 therapy is intended to correct or improve the deficiency in CD4 cells, while maintaining a high frequency of CD8+ HIV-specific CTL and increasing natural killer (NK) cells. After a year of HAART plus IL-2, it may be possible to discontinue HAART while maintaining IL-2 stimulatory therapy, and the immune reactivity repaired and stimulated by IL-2 should be able to contain the virus and maintain latency.
Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on their current HAART regimen. IL-2 therapy is initiated at Month 3 of HAART. IL-2 is injected subcutaneously daily for 9 months, in addition to HAART. After completion of this 1-year treatment period, patients are evaluated for discontinuation of HAART. Patients with a viral load below 50 copies/ml throughout HAART plus IL-2, a CD4 count of at least 500 cells/mm3, and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as monotherapy for an additional 6 months. After completing 6 months of IL-2 monotherapy, eligible patients may have IL-2 therapy discontinued.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins Hosp
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Patients may be eligible for this study if they:
- HIV-infected.
- Viral load of 5,000 copies/ml or less within 3 months.
- Completed at least 3 months of anti-HIV medications.
- Have a refrigerator to store the needles for IL-2 shots.
Exclusion Criteria
- Glucocorticoids or other drugs that affect the immune system such as INF-alpha, G-CSF, or GM-CSF.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:A
Patients will recieve a daily, self-administered subcutaneous injection of IL-2 while continuing treatment with their current oral anti-HIV medications
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Subcutaneous injection of IL-2 in the amount of 2.0 X 10^6 mIU per day for the entire duration of therapy
其他名称:
Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met
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有源比较器:B
Patients will only follow their current oral anti-HIV medication regimen.
No additional IL-2 injection will be given.
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Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Augmentation and extention of HTL response
大体时间:Throughout study
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Throughout study
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Reduction in extent of damage and acceleration of immune system recovery
大体时间:Throughout study
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Throughout study
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Delay of and reduction in recurrent viremia compared to historical controls
大体时间:Throughout study
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Throughout study
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合作者和调查者
调查人员
- 首席研究员:Joseph B Margolick
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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