NCT00304642已完成1 期
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.
研究概览
简要总结
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.
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
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 and informed consent form.
- •Willing to be tested for HIV and to use an experimental vaginal gel.
- •Willing to use a reliable form of contraception during the study.
- •Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study.
- •Normal cervical assessment.
- •Willing to abstain from using any vaginal product (other than the study product).
- •Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10.
排除标准
- •Currently pregnant or breast-feeding.
- •Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix.
- •Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test.
- •Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.
- •Current use of injection drugs.
结局指标
主要结局
To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.
次要结局
未报告次要终点
研究者
研究点 (1)
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