A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
研究概览
简要总结
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, age 18-35 years
- •Willing and able to provide written informed consent
- •HIV-uninfected and otherwise healthy
- •Self-reported sexually active
- •On a stable hormonal contraceptive regimen
- •Regular menstrual cycle
- •Willing to refrain from use of vaginal products or objects during the study
排除标准
- •Currently pregnant or last pregnancy within 3 months prior to enrollment
- •Currently breast-feeding
- •Participated in any other research study within 30 days prior to enrollment;
- •Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
- •Presence of abnormal physical finding on the vulva, vaginal walls or cervix
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
- •Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
- •Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
- •Any serious acute, chronic or progressive disease
研究组 & 干预措施
A
vaginal ring first 12 weeks & observational safety last 12 weeks
干预措施: intravaginal ring (Device)
B
observational safety first 12 weeks & vaginal ring last 12 weeks
干预措施: intravaginal ring (Device)
结局指标
主要结局
The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
时间窗: 3 months
The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events
时间窗: 3 months
次要结局
未报告次要终点