NCT00469768已完成1 期
A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine
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
- 24
- 试验地点
- 1
研究概览
简要总结
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18 and 35 years of age
- •Willing and able to give written informed consent
- •Available for all visits and consent to follow all procedures scheduled for the study
- •Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
- •Willing to abstain from sexual activity for the duration of the study
- •Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
- •Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
- •Willing to refrain from use of vaginal products or objects 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 compliance with protocol requirements;
- •History of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
- •Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
- •Currently or within one month of participating in any other clinical research study
- •History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
- •History of genital tract surgery within the last month
- •Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
- •Current vulvar or vaginal symptoms / abnormalities that could influence the study results
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
- •Smoking more than 10 cigarettes per day
研究组 & 干预措施
A
Experimental
干预措施: dapivirine matrix intravaginal ring (Drug)
B
Experimental
干预措施: dapivirine reservoir intravaginal ring (Drug)
C
Placebo Comparator
干预措施: placebo intravaginal ring (Other)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal GelsHIV InfectionsNCT00613249International Partnership for Microbicides, Inc.36
Unknown
1 期
A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.Esophageal CancerNCT04460066Lee's Pharmaceutical Limited70
Unknown
1 期
A Study to Evaluate the Safety and Effect of STC314 Injection Continuous Infusion in Subjects With Acute Respiratory Distress SyndromeAcute Respiratory Distress SyndromeNCT05000671Grand Medical Pty Ltd.16
已完成
1 期
A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 VaccineCOVID-19 Respiratory InfectionCOVID-19 Vaccine Adverse ReactionNCT05685953Matti Sällberg16
已完成
3 期
Trial of Imatinib for Hospitalized Adults With COVID-19COVID-19NCT04394416University of Maryland, Baltimore21