Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.
研究概览
简要总结
We will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-40 years of age at the time of screening
- •Willing to be screened for HSV-2 using a rapid, FDA approved test
- •Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
排除标准
- •Pregnant or nursing mother
- •Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days
- •Presence of any intrauterine device
- •Allergy or hypersensitivity to valcyclovir or nucleoside analogues
- •Enrollment Inclusion Criteria:
- •Women 18-40 Years of age at the time of screening
- •HSV-2 seropositive as determined by rapid HSV-2 testing
- •Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
- •Willing to avoid use of any intravaginal products during study period
- •Capable of providing written informed consent
- •Capable of cooperating to the extent and degree required by this protocol
- •Enrollment Exclusion Criteria:
- •Pregnancy (all women will have a urine pregnancy test prior to randomization and treatment)
- •nursing mother
- •Menopausal women
- •Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment
- •Known immunocompromised state
- •Significant Medical disorder that precludes accurate evaluation of participants condition
- •Presence of any intrauterine device
- •History of significant hepatic or renal impairment
- •Sensitivity/allergy to valacyclovir or nucleoside analogues
- •history of acyclovir or valacyclovir resistant HSV infection
- •Participation in a study using an investigational product in the past 30 days
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
Valacyclovir 1 gm daily x number of days active in the study
干预措施: Valacyclovir (Drug)
结局指标
主要结局
The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.
时间窗: within 90 days of enrollment
次要结局
- The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.(within 90 days of enrollment)
研究者
Thomas L. Cherpes, MD
Assistant Professor
University of Pittsburgh