A Double-Blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5g and Dapivirine Gel 4789, 0.05%, 2.5g Formulations and to Assess the Safety as Compared to the Intravaginal HEC-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples
研究概览
简要总结
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal HEC-based universal placebo gel.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18 and 40 years of age, inclusive
- •Willing and able to give written informed consent
- •Available for all visits and consent to follow all procedures
- •Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function
- •HIV-negative as determined by a HIV-1 ELISA test at enrollment
- •Willing to abstain from sexual activity for the duration of the study
- •On stable oral contraceptive regimen for 2 months prior to enrollment and willing to continue
- •Upon pelvic/speculum examination, the cervix and vagina appear normal
- •Willing to refrain from the use of vaginal products from 14 days prior to enrollment and for the duration of the study
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 adherence with protocol requirements
- •History of sensitivity/allergy to any component of the study product or to latex
- •Currently pregnant or breast-feeing, or within 3 months of last pregnancy outcome
- •Currently or within one month of participating in any other clinical research study
- •History or current diagnosis and/or treatment for a STD within the last three months prior to enrollment
- •Current vulvar, vaginal or cervical symptoms/abnormalities as determined by pelvic/speculum exam or colposcopy that could influence the study results
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months
- •Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
- •Smoking more than 10 cigarettes a day
研究组 & 干预措施
B
干预措施: Dapivirine Gel 4789, 0.05%, 2.5g (Drug)
A
干预措施: Dapivirine Gel 4750, 0.05%, 2.5g (Drug)
C
干预措施: HEC-based Placebo Gel (Drug)
结局指标
主要结局
Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples
时间窗: 11 days
Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events
时间窗: 14 days
次要结局
未报告次要终点