NCT01952561已完成1 期
An Open-label, Parallel-group Pharmacokinetic Trial in Healthy HIV-negative Women to Characterize the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring 004), Containing 25 mg of Dapivirine, Over Various Ring Use Periods
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
- 40
- 主要终点
- dapivirine pharmacokinetics in plasma
研究概览
简要总结
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
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
- None
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 18 and ≤ 40 years of age who can give written informed consent
- •Available for all visits and consent to follow all procedures scheduled for the trial
- •Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections, and laboratory evaluations for haematology and chemistry
- •HIV-negative as determined by an HIV test at the time of enrolment
- •On a stable form of contraception, defined as:
- •A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR
- •Transdermal contraceptive patch for at least 3 months prior to enrolment, OR
- •Long-acting progestins for at least 6 months prior to enrolment, OR
- •An IUD inserted at least 3 months prior to enrolment, OR
- •Have undergone surgical sterilisation at least 3 months prior to enrolment AND willing to use oral contraceptives if necessary to delay menstruation during the vaginal sampling period
- •Upon pelvic examination at the time of enrolment, the cervix and vagina appear normal as determined by the Investigator/Physician
- •Asymptomatic for genital infections at the time of enrolment
- •Willing to refrain from the use of topical vaginal medications, vaginal products or objects
- •Documentation of no abnormality on cervical cytology, including grossly bloody smear, within 90 days prior to screening
- •Willing to refrain from participation in any other research trial for the duration of this trial
- •Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures, e.g. by home visit or telephone, or via family or close neighbour contacts
- •Willing to agree to abstain from all the following for a total of 2 days (48 hours) prior to each trial visit:
- •Penile-vaginal intercourse
- •Oral contact with her genitalia
- •Hepatitis B and C negative at the time of enrolment.
排除标准
- •Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
- •Currently breast-feeding
- •Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening
- •Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment
- •Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
- •Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
- •Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
- •Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
- •Any Grade 2, 3 or 4 haematology, biochemistry or urinalysis laboratory abnormality at baseline (screening) according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
- •Unexplained, abnormal 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
- •Any serious acute, chronic or progressive or signs of cardiac disease, renal failure, or severe malnutrition
- •Have undergone a hysterectomy
- •Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
研究组 & 干预措施
2 weeks
Experimental
干预措施: dapivirine ring (Drug)
1 week
Experimental
干预措施: dapivirine ring (Drug)
4 weeks
Experimental
干预措施: dapivirine ring (Drug)
8 weeks
Experimental
干预措施: dapivirine ring (Drug)
12 weeks
Experimental
干预措施: dapivirine ring (Drug)
结局指标
主要结局
dapivirine pharmacokinetics in plasma
时间窗: 1,2,4,8 or 12 weeks
次要结局
未报告次要终点
研究者
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