The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
研究概览
简要总结
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
详细描述
It is generally accepted that HIV-infected pregnant women should receive treatment to prevent the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs during pregnancy make a PI based regimen the most rational choice. Based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV infected woman
- •18 - 40 years of age
- •able and willing to sign Informed Consent
- •pregnant for a maximum of 31 weeks
排除标准
- •history of sensitivity/idiosyncrasy to the drug
- •relevant history of interference with drug metabolism
- •inability to understand trial procedures
- •abnormal specific serum levels
- •use of specific concomitant medications
- •active hepatobiliary or hepatic disease
- •previous failure of saquinavir/ritonavir regimen
结局指标
主要结局
pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
次要结局
- antiviral activity
- safety