NCT01071174已完成1 期
A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.
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, Care Provider, Investigator)
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 who can provide informed consent
- •Available for all visits and consent to follow all procedures scheduled for the study
- •Healthy and self-reported sexually active
- •HIV-negative
- •On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
- •In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses
- •Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator
- •Asymptomatic for genital infections at the time of enrolment
- •Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study
- •Willing to answer to acceptability, adherence and behavioural assessments throughout the study
- •Willing to refrain from participation in any other research study for the duration of their participation
- •Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures
排除标准
- •Currently pregnant or last pregnancy within 3 months prior to enrolment
- •Currently breast-feeding
- •Participated in any other research study within 60 days prior to screening
- •Previously participated in any HIV vaccine study
- •Untreated urogenital infections within 2 weeks prior to enrolment
- •Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence
- •Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation
- •Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events
- •Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
- •Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer
- •Any serious acute, chronic or progressive disease
- •Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives
研究组 & 干预措施
Placebo Ring
Placebo Comparator
Vaginal Ring containing no drug substance
干预措施: Placebo (Other)
Dapivirine Ring
Experimental
Dapivirine Vaginal Ring 25mg
干预措施: Dapivirine (Other)
结局指标
主要结局
Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.
时间窗: 16 weeks
次要结局
- Acceptability of the product determined by questionnaire.(16 weeks)
- Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.(12 weeks)
研究者
研究点 (10)
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