Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions
研究概览
简要总结
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.
详细描述
A new approach to HIV prevention currently being studied is the use of topical microbicides. This study will measure the mucosal response to daily intravaginal applications of 1% tenofovir gel versus placebo in two groups of women at low risk for HIV infection.
The duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply 1% tenofovir gel daily for 14 consecutive days between menses. Group 2 participants will apply placebo gel for 14 consecutive days between menses.
Study visits will occur on Days 3, 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 30 days of screening. Medical and sexual history, a pelvic exam, cervicovaginal lavage sample collection, blood collection, vaginal pH testing, STI testing, and adverse effect reporting will occur at all visits. All participants will be asked to complete a diary throughout the study; this diary will be reviewed at all study visits. A Pap smear will be obtained at screening if documentation of a negative Pap smear result within the last year is not available.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal menstrual history with regular cycles and with a minimum of 21 days between menses
- •Sexually abstinent or in a stable, mutually monogamous relationship with a partner who is HIV uninfected
- •Agree to abstain from sexual intercourse and to not use vaginal products within 48 hours of study entry and for the duration of the study
排除标准
- •HIV infected
- •Sexually transmitted infection within 6 months of study entry
- •Use of nontherapeutic intravenous drugs within 12 months of study entry
- •Menopausal
- •Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
- •Menstruating at screening or enrollment visits
- •Positive urine culture
- •Positive chlamydia, gonorrhea, or trichomonas result at screening
- •Abnormal Pap smear
- •Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.
- •History of toxic shock syndrome or a history of symptoms suggesting toxic shock syndrome
- •History of intermenstrual bleeding within 3 months of study entry
- •Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months of study entry
- •Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month of study entry
- •Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours of study entry
- •Acute or chronic hepatitis B virus infection
- •Liver or kidney abnormalities
- •Oral antibiotics within 7 days of study entry
- •Pregnant, less than 6 months postpartum, or breastfeeding
研究组 & 干预措施
1
Application of 1% tenofovir gel for 14 consecutive days between menses
干预措施: Tenofovir gel (Drug)
2
Application of 1% tenofovir placebo gel for 14 consecutive days between menses
干预措施: Tenofovir gel placebo (Drug)
结局指标
主要结局
Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions
时间窗: At Days 3, 7, 14, and 21
次要结局
- Changes in antimicrobial activity of cervicovaginal secretions(At Day 14)