A Safety Study of Dapivirine Vaginal Ring in Africa
2011年8月1日 更新者：International Partnership for Microbicides, Inc.
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.
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.
研究概览
研究类型
介入性
注册 (实际的)
280
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kwazulu Natal
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Edendale、Kwazulu Natal、南非
- Reproductive Health and HIV Research Unit (RHRU)
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Ladysmith、Kwazulu Natal、南非
- Qhakaza Mbokodo
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Pinetown、Kwazulu Natal、南非
- Prevention for HIV and AIDS Project (PHIVA)
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North West
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Brits、North West、南非
- Madibeng Centre for Research
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Western Cape
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Cape Town、Western Cape、南非
- Desmond Tutu HIV Foundation Masiphumelele
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Cape Town、Western Cape、南非
- Desmond Tutu HIV Foundation Nyanga
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Paarl、Western Cape、南非
- Be Part Yoluntu Centre Mbekweni
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Moshi、坦桑尼亚
- Kilimanjaro Christian Medical Centre (KCMC)
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Kisumu、肯尼亚
- Kenya Medical Research Institute (KEMRI)
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Lilongwe、马拉维
- University of North Carolina Project
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Placebo Ring
Vaginal Ring containing no drug substance
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不含药物的阴道环
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实验性的：Dapivirine Ring
Dapivirine Vaginal Ring 25mg
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Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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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.
大体时间：16 weeks
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16 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Acceptability of the product determined by questionnaire.
大体时间：16 weeks
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16 weeks
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Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.
大体时间：12 weeks
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12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Dr Annalene Nel、IPM
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年4月1日
初级完成 (实际的)
2011年5月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2010年2月17日
首先提交符合 QC 标准的
2010年2月18日
首次发布 (估计)
2010年2月19日
研究记录更新
最后更新发布 (估计)
2011年8月2日
上次提交的符合 QC 标准的更新
2011年8月1日
最后验证
2011年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.