Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- FHI 360
- 入组人数
- 2,160
- 试验地点
- 2
- 主要终点
- Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
研究概览
简要总结
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
详细描述
This is a Phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at high risk for HIV infection. Eligible participants who are HIV negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos, Nigeria. The enrollment phase will last until 2,160 women have enrolled. It is anticipated that the enrollment will be completed within 12 months.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent
- •At least 18 years old and not more than 35 years old
- •Average of three vaginal coital acts per week with a male partner
- •More than one male sexual partner in the last 3 months
- •Willing to use study product as directed
- •Willing to adhere to follow-up schedule
- •Willing to participate in the study for 12 months
- •Willing to report self-medication during study participation
- •Willing to give urine for pregnancy testing; self-administered vaginal swabs for GC/CT testing; OMT for HIV monthly; finger prick for HIV confirmation if required; and blood draw for syphilis and HIV at baseline, and for HIV at the final visit
- •Willing to not use a spermicide, other vaginal contraceptive, or vaginal lubricant during the study
- •At least 3 months since end of the last pregnancy
排除标准
- •History of adverse reactions to the study products, including latex
- •Pregnant or desire a pregnancy during the 12 months of participation
- •Injection drug user
- •Gynecological abnormality that may have an impact on the safety and/or response to the study gel according to the investigator
- •HIV positive as diagnosed by OraQuick® rapid test
- •Participation in any other microbicide research
- •Discontinued from the CS study previously
- •Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
结局指标
主要结局
Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
次要结局
- Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.