NCT00195234已完成1 期
A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.
Wyeth is now a wholly owned subsidiary of Pfizer10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
研究概览
简要总结
The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.
A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
- •CD4 T-cell count greater than and equal to 350/mm3 at screening
- •No reported CD4 T-cell count less than 350/mm3 at any time before screening
- •Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening
排除标准
- •Any chronic symptomatic infection other than HIV
- •Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
- •Any malignancy that may require systemic therapy
- •Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG
结局指标
主要结局
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
次要结局
- To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
研究者
研究点 (10)
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