NCT00304668撤回1 期
A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel (TMC120 Gel-002) vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Local and systemic safety and tolerability.
研究概览
简要总结
Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •HIV-negative
- •Willing to participate and sign an informed consent form
- •Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
- •Willing to use two forms of contraception during the study
- •Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
- •Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses
排除标准
- •Currently pregnant or breast-feeding
- •Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
- •Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
- •Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
- •Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
- •Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
结局指标
主要结局
Local and systemic safety and tolerability.
次要结局
未报告次要终点
研究者
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