A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
研究概览
简要总结
The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.
详细描述
The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, HIV-1 seronegative women of child-bearing age.
排除标准
- •Current use of hormonal contraception
- •Pregnancy/Breast Feeding
- •Post-menopausal status
- •Hepatitis B or C
- •Psychiatric illness
- •Active Substance Abuse
研究组 & 干预措施
levonorgestrel, efavirenz
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
干预措施: levonorgestrel, efavirenz (Drug)
结局指标
主要结局
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
时间窗: 12 hour pharmacokinetic study
次要结局
- Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz(12 hour pharmacokinetic study)
- Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz(3 weeks)
- Changes in liver function tests before and during efavirenz(3 weeks)
- The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls(12 hour pharmacokinetic study)