NCT02858037已完成3 期
A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,456
- 试验地点
- 21
- 主要终点
- The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
研究概览
简要总结
HIV Open-label Prevention Extension (HOPE).
详细描述
A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 must meet all of the following criteria to be eligible for inclusion in the study
- •Previously enrolled in MTN-020 (ASPIRE)
- •Able and willing to provide written informed consent to be screened for and to take part in the study
- •Able and willing to provide adequate locator information, as defined in site SOPs
- •HIV-uninfected based on testing performed by study staff at Screening and Enrollment
- •Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs)
- •At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation
排除标准
- •Women who meet any of the following criteria will be excluded from the study
- •Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial
- •Per participant report at Screening:
- •Plans to relocate away from the study site during study participation
- •Plans to travel away from the study site for more than three consecutive months during study participation
- •Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP)
- •With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment
- •Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period
- •Currently breastfeeding
- •Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines
- •At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
- •Has any of the following laboratory abnormalities at Screening Visit:
- •Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3*
- •Creatinine > Grade 3*
- •Hemoglobin > Grade 3*
- •Platelet count > Grade 3*
- •Pap result ≥ Grade 3 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)
- •Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
结局指标
主要结局
The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
时间窗: 13 months
Number of participants Grade 2, Grade 3, and all serious Adverse Events.
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
时间窗: 13 months
By measuring the residual levels of dapivirine in returned used vaginal rings.
次要结局
- Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.(13 months)
- Incidence of HIV-1 Infection(13 months)
研究者
研究点 (21)
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