Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- PK parameters
研究概览
简要总结
Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not yet been determined. The primary purpose of this study is to examine whether a pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.
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
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV positive females between 21-40 years of age.
- •Subjects must be receiving anti-HIV regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study.
- •Subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days.
排除标准
- •Subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study.
- •Subjects may not have the intrauterine device (IUD), Mirena, in place to prevent pregnancy.
研究组 & 干预措施
HIV+ Female
HIV infected women between 21-40 years of age, not receiving oral contraceptives.
干预措施: Tenofovir, Emtricitabine, Atazanavir, Ritonavir (Drug)
结局指标
主要结局
PK parameters
时间窗: 28 days
The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir
次要结局
未报告次要终点
研究者
Jennifer King
Assistant Professor
University of Alabama at Birmingham