NCT00006327已完成3 期
A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
VaxGen1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 1999年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
详细描述
Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior effects associated with study participation are assessed.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers may be eligible for this study if they:
- •Are 20 to 60 years old.
- •Are HIV-negative.
- •Have used intravenous drugs in the previous 12 months.
- •Are available and commit to 3 years of follow-up.
- •Have a Thai National ID or its equivalent such as government official ID or state enterprise ID.
- •Are able to understand the study and pass a test showing they understand it, and give written informed consent.
排除标准
- •Volunteers will not be eligible for this study if they:
- •Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study.
- •Are HIV-positive.
- •Have ever received an experimental HIV-1 vaccine.
- •Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation).
- •Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection.
- •Have received immunoglobulins for a long time.
- •Have received non-licensed, research agents within 4 weeks of the first study injection.
- •Expect to miss study visits or plan to move within 36 months.
- •Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period.
- •Are women who have sex with men and do not plan to use effective birth control.
研究者
研究点 (1)
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