NCT03377608已完成不适用
Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cervical Tissue Concentrations
研究概览
简要总结
Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, or transgender female with a cervix, aged 18-35 years old
- •HIV-positive
- •Stable on antiretroviral regimen containing TDF 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
- •Currently pregnant or previous pregnancy within 3 months of enrollment
- •Currently breast feeding
- •Symptomatic vaginal infection within 2 weeks prior to enrollment
- •Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
- •History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
- •Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
研究组 & 干预措施
Depo-Provera
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Depo-Provera
干预措施: Depo-Provera (Drug)
Non-hormonal contraception
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
Cervical Tissue Concentrations
时间窗: Day 1
Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues
次要结局
- Gene expression of drug metabolizing enzymes and transporters(Day 1)
- Vaginal microbiome(Day 1)
- Proinflammatory cytokines(Day 1)
研究者
研究点 (1)
Loading locations...
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