NCT00213083已完成3 期
Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
Population Council6 个研究点 分布在 1 个国家目标入组 6,203 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,203
- 试验地点
- 6
- 主要终点
- Time to HIV seroconversion during trial participation (evaluated quarterly)
研究概览
简要总结
The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.
详细描述
This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.
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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV negative and agree to be tested for HIV and told their results at all visits during the study
- •Aged 16 - 40 years of age
- •Have had at least one vaginal intercourse within the last three months
- •Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
- •Provide locator information to study staff throughout the trial
- •Comply with all aspects of the study protocol, including random assignment to the Carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen
- •Citizen or permanent resident of South Africa
- •Resident for the past year and intends to reside in the catchment area of the site for the next two years
- •During the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician.
排除标准
- •Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
- •Within four weeks of last pregnancy outcome at the time of enrolment
- •Pap smear at screening is graded as carcinoma.
- •Injected illicit drugs in the 12 months prior to screening
- •Participating in any other clinical trial/HIV prevention study
结局指标
主要结局
Time to HIV seroconversion during trial participation (evaluated quarterly)
次要结局
- Determine long-term safety based on the incidence of sexually transmitted infections (STI), Chlamydia, gonorrhoeae, trichomoniasis, and syphilis tests and the number of adverse events and serious adverse events
- Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated
研究者
研究点 (6)
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