Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Infected Patients
A Single Center Phase I Safety and Immunogenicity Study of Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) for Immunotherapy of HIV-1 Infected Individuals Receiving Highly Active Antiretroviral Therapy (HAART)
研究概览
详细说明
Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses contribute to the control and potential clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies have shown that the vaccine induces strong CTL responses in animal models. This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy (HAART) and have a CD4 count of 350 cells/mm3 or more and fully suppressed viral replication on stable HAART.
Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4, 8, and 16. Participants will be randomly assigned to receive either vaccine or placebo. Ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Colorado
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Denver、Colorado、美国、80262
- University of Colorado, Health Science Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Documented HIV-1 infection
- Taking HAART for 6 months or longer and on stable HAART for at least 4 weeks
- Plasma HIV-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry
- CD4 count of 350 cells/mm3 or more within 30 days of entry
Exclusion Criteria
- Immunomodulatory agents
- Prior receipt of experimental HIV vaccines in the 5 years prior to study entry
- Hepatitis B surface antigen or hepatitis C virus antibody positive
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：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
Immunization on Day 0 and Weeks 4, 8, and 16
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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 |
|---|---|
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Safety and efficacy of four intramuscular doses of EP HIV-1090 to HIV infected participants using highly active antiretroviral therapy (HAART), who have a viral load less than 400
大体时间：Throughout study
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Throughout study
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Peripheral blood CD8 T-cell (CTL) responses to vaccine, compared to placebo
大体时间：Throughout study
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Throughout study
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CD4 T-cell count and viral load in patients continuing HAART following vaccination or receipt of placebo
大体时间：Throughout study
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Throughout study
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Clinical signs and symptoms and development of AIDS-defining clinical events following vaccination or receipt of placebo in participants who remain on HAART
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
- 学习椅：Constance Benson, MD、University of California, San Diego
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
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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