Virologic, Pharmacologic, and Immunologic Characterization of the Female Upper Genital Tract in HIV-infected Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Immune characteristics
研究概览
简要总结
The female upper genital tract is a unique compartment involved in HIV pathogenesis.
详细描述
The persistent detection of HIV in the female genital tract in spite of ART is unexplained, and it is possible the uterine endometrium serve as a reservoir. There are limited data regarding the interaction between HIV expression, antiretroviral therapy (ART) and host immune system in the uterine endometrium.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regularly menstruating women (between 21-42 days)
- •between ages 25-50 years
- •Fully suppressed by antiretroviral therapy with plasma HIV RNA < 40 copies/mL within the last 6 months.
排除标准
- •Pregnant or planning pregnancy
- •Unwilling to use 2 forms of contraception (condoms + hormonal) if they did not have previous bilateral tubal ligation procedure
- •Intrauterine device in place
- •Untreated cervical infection (N. gonnorhea, C. trachomatis)
- •Taking immunosuppressive medications
结局指标
主要结局
Immune characteristics
时间窗: Single visit approximately 14-42 days after the first day of the last menstrual period.
Endometrial lavage (EML) and biopsy (EMB) samples were compared to cervicovaginal lavage (CVL) and fluid (CVF) samples from HIV-negative healthy women (N=x) and HIV-infected women (n=x) taking ART with plasma HIV RNA \<40 copies/mL. All participants were in the luteal phase of the menstrual cycle. Immunologic study was completed using Luminex and flow cytometry. Concentrations of tenofovir (TFV), emtricitabine (FTC) and their active intracellular metabolites (TFVdp and FTCtp) were measured using LC-MS/MS in 11 HIV-infected women. HIV RNA was measured in plasma, EML and CVL using the Abbott RealTime HIV-1 assay (lower limit of detection 40 copies/mL).
次要结局
未报告次要终点
研究者
Lisa Rahangdale, MD, MPH
Assistant Professor
University of North Carolina, Chapel Hill