Vaginal Innate Immunity in Normal and HIV-Infected Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant and non-pregnant women who are HIV-negative.
研究概览
简要总结
The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection.
The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 40 years
- •Able to provide informed consent
排除标准
- •Women with the following conditions will be excluded:
- •Currently active Syphilis or Herpes simplex infection
- •Other (non-HIV) comorbid conditions causing acute or chronic inflammatory states or immunosuppression (i.e., transplant recipients, active systemic lupus)
- •Current use of hormonal birth control or with IUD in place
- •History of Hysterectomy or bilateral oophorectomy
- •Women with the following conditions will require rescheduling of the study visit:
- •Use of hot tub or pool, vaginal creams, douches, vaginal medications, or vaginal intercourse within 48 hours
- •Current vaginal bleeding
- •Recent treatment for vaginal infection will require 4 - 6 week delay in enrollment
- •Pregnant women with the following conditions at the time of examination will be excluded:
- •Active labor or other conditions of duress
- •Signs or symptoms of preterm labor
- •Vaginal bleeding
- •Placenta previa
- •History of prior preterm birth
- •Ruptured amniotic membranes
- •Multifetal gestation
- •Stillbirth or intrauterine fetal demise (IUFD)
结局指标
主要结局
To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant and non-pregnant women who are HIV-negative.
时间窗: up to 2 clinic visits in 10 weeks
Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). These antimicrobial host defense peptides are produced by genital tract mucosal epithelial cells and associated immune cells, and have a wide range of antiviral, antibacterial, antifungal and antiparasitic activities and modes of action. We hypothesize that changes in innate immunity markers take place during pregnancy, thereby changing native vaginal immunity.
次要结局
- To compare the vaginal concentrations of innate immunity markers (alpha and beta) interferon, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI)) in HIV-positive pregnant and non-pregnant women(up to 2 clinic visits in 10 weeks)
- To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant women who are HIV-negative to pregnant women who are HIV-positive.(up to 2 clinic visits in 10 weeks)
研究者
Joseph Politch
Faculty, OBGYN
Boston Medical Center