NCT00700284已完成1 期
Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
研究概览
简要总结
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 18-50 years, inclusive
- •Willing and able to provide written informed consent
- •HIV-uninfected and otherwise healthy
- •Willing to abstain from sexual activity and use of vaginal products while participating in the trial
- •Currently using oral contraceptives for pregnancy prevention
- •Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial
排除标准
- •History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
- •History of allergy to TMC120 or to the constituents of the vaginal ring.
- •History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
- •History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
- •History of genital tract surgery within the last month
- •Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
- •Currently or within one month of participating in any other clinical research trial
- •Current (during screening) diagnosis of any genital infection
- •Current vulvar of vaginal symptoms
- •Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
研究组 & 干预措施
A
Placebo Comparator
干预措施: placebo vaginal ring (Drug)
B
Experimental
干预措施: TMC120 (dapivirine) vaginal ring (Drug)
结局指标
主要结局
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
时间窗: 7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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