Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,428
- 试验地点
- 5
- 主要终点
- Combined incidence of HIV-1 and HIV-2 in the study.
研究概览
简要总结
The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse. The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route.
The study hypothesis is that there will be no effect.
详细描述
Despite the availability of an effective HIV prevention method, i.e. the condom, the epidemic continues growing. There is thus an urgent need for additional HIV prevention methods. One of the possibilities is the use of microbicides, i.e. chemical products which may be used in the vagina or rectum with the potential to prevent HIV infection.
Cellulose sulfate is an HIV entry inhibitor with an in vitro effect on N. gonorrhoeae (NG) and C. trachomatis (CT) and other sexually transmitted organisms.
The study assess its effect on the vaginal transmission of HIV, NG and CT among women at high risk of heterosexual STI infection (defined as having had more than two partners in the last three months and an average of three sexual acts per week).
The study is randomized, triple-blinded, placebo controlled.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at least 18 years old
- •an average of at least three vaginal sex acts per week, at least three different partners in the last three months, expecting to continue this behavior
- •HIV negative
- •willing and able to comply with the protocol
排除标准
- •pregnancy
- •allergy to latex or spermicides
- •intravenous drug user
结局指标
主要结局
Combined incidence of HIV-1 and HIV-2 in the study.
时间窗: 1 year
次要结局
- Time-to-first incidental gonococcal or chlamydial infection.(1 year)