NCT01048372已完成不适用
An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.
研究概览
简要总结
Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.
详细描述
The initial phase of this in vitro study regarding the potential mechanisms of action of Cytolin was completed in January 2011. Given the data set to date, a decision has been made to extend the study. The extension will allow the Company to further confirm and extend the initial findings regarding the potential mechanism of action of Cytolin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV seropositive
- •viral load < 100,000 copies/ml
- •CD4+ > 350 cells/ul
- •Ability and willingness to give written informed consent.
- •Control Group
- •Inclusion Criteria:
- •HIV seronegative subjects identified as HIV uninfected by a nonreactive HIV 1/2 ELISA.
- •Ability and willingness to give written informed consent.
排除标准
- •Presentation with an opportunistic infection or AIDS-defining illness.
- •Receipt of investigational research agent within 30 days prior to study entry.
- •Prior receipt of experimental HIV vaccine, sham vector or adjuvant.
- •Receipt of immunosuppressive medications or immune modulators within the past six months. Individuals taking corticosteroid nasal spray for allergic rhinitis, topical steroid or over the counter medications for acute, uncomplicated dermatitis for a period no longer than 14 days will not be excluded.
- •Active drug or alcohol use, dependence or psychiatric illness that in the opinion of the study investigator would interfere with adherence to study protocol.
- •Serious illness requiring hospitalization.
结局指标
主要结局
T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.
时间窗: Entry, 3 months, 6 months
次要结局
- In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.(Entry, 3 months, 6 months)
研究者
研究点 (1)
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