NCT01549119已完成1 期
Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients
InnaVirVax4 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年2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
- 33
- 试验地点
- 4
- 主要终点
- Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
研究概览
简要总结
The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected patient
- •Age between 18 and 55 years
- •ART (AntiRetroviral Therapy) initiation 1 year ago
- •Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months
- •CD4 T cell count above or equal to 200 cells per mm3,
- •Nadir CD4 T cell count above or equal to 100 cells per mm3,
- •Contraception in women with child-bearing potential
排除标准
- •Any ART change within a month preceding screening.
- •Chronic active liver disease, HIV-Hepatitis Coinfection.
- •Immunotherapy in the past year, immunosuppressive treatment within the past month.
- •History of auto-immune disease
结局指标
主要结局
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
时间窗: from D0 to week 24
Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
次要结局
- NKp44L expression on the surface of CD4+ T lymphocytes(from D0 to week 60)
- Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.(from week 24 to week 60)
- Anti-3S antibody titers(from D0 to week 60)
- Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation.(from D0 to week 60)
研究者
研究点 (4)
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