Safety of Acidform Lubricant (Amphora) 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
- 35
- 试验地点
- 1
- 主要终点
- Measured endogenous antimicrobial activity
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 pathogens. 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 compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.
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 Acidform lubricant and HEC gel in two groups of healthy women at low risk for HIV infection.
The duration of this study for each participant is 3 weeks. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply Acidform lubricant twice daily for 14 consecutive days between menses. Group 2 participants will apply HEC gel for 14 consecutive days between menses.
After screening and study entry, study visits will occur on Days 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 45 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. Cytobrush collection, vaginal swab, and cervical biopsy will occur at selected 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
- Treatment
- 盲法
- None
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
- •Low risk for HIV/STI infection. More information on this criterion can be found in the protocol.
- •Agree to abstain from vaginal and anal intercourse and to not use vaginal products within 48 hours prior to study entry and for the duration of the study
排除标准
- •HIV-infected
- •Menopausal
- •Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
- •Menstruating at screening or enrollment visits
- •Urinary tract infection at screening
- •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.
- •Currently participating in a research study of other vaginal products
- •History of intermenstrual bleeding within 3 months prior to study entry
- •Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months prior to study entry
- •Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month prior to study entry
- •Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours prior to study entry
- •Vaginal or anal intercourse during the 48 hours prior to study entry
- •Oral antibiotics within 7 days of study entry
- •Pregnant, less than 6 months postpartum, or breastfeeding
研究组 & 干预措施
1
Participants will apply Acidform lubricant twice daily for 14 consecutive days between menses
干预措施: Acidform Lubricant (Drug)
2
Participants will apply HEC gel twice daily for 14 consecutive days between menses
干预措施: HEC gel (Drug)
结局指标
主要结局
Measured endogenous antimicrobial activity
时间窗: Throughout study
Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL
时间窗: Throughout study
次要结局
- Changes in vaginal flora following Acidform and HEC application(Throughout study)
- Antiviral activity in CVL following Acidform and HEC application(Throughout study)
- Changes in epithelial integrity after Acidform and HEC application(Throughout study)
- Extent and duration of buffering measured by vaginal pH(Prior to and 2 hours after first application)