A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety assessed by grade 2 or higher adverse event.
研究概览
简要总结
Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.
详细描述
The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
- •Able and willing to provide adequate locator information and comply with all study procedural requirements.
排除标准
- 未提供
研究组 & 干预措施
Vaginal Matrix Ring
Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month.
干预措施: Dapivirine (Drug)
Oral Emtricitanbine/Tenofovir Disoproxil
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily
干预措施: Truvada (Drug)
结局指标
主要结局
Safety assessed by grade 2 or higher adverse event.
时间窗: 12 months
To compare the safety profiles of FTC/TDF oral tablet administered daily and dapivirine vaginal matrix ring (25 mg) inserted for use of each study product in an adolescent and young adult female population
次要结局
未报告次要终点