NCT03218085已完成不适用
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues
研究概览
简要总结
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, or transgender female with a cervix, age 18 years or older
- •HIV-positive
- •Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
- •Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
- •Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
- •Willing and able to give signed informed consent.
排除标准
- 未提供
结局指标
主要结局
Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues
时间窗: Day 1
次要结局
- To identify potential role of the vaginal microbiome in local drug disposition,(Day 1)
- To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue(Day 1)
- To determine relationship between local inflammation and drug disposition in the female genital tract(Day 1)
- To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues(Day 1)
- To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.(Day 1)
研究者
研究点 (1)
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