Special Investigation of Kaletra in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Number of Patients With Adverse Drug Reactions (ADRs)
研究概览
简要总结
This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study
排除标准
- •Contraindications according to the Package Insert:
- •Patients with a history of hypersensitivity to any ingredient of Kaletra
- •Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol
研究组 & 干预措施
Lopinavir/ritonavir group
All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
干预措施: Lopinavir/ritonavir (Kaletra) (Drug)
结局指标
主要结局
Number of Patients With Adverse Drug Reactions (ADRs)
时间窗: During pregnancy and for one year after birth
The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
次要结局
未报告次要终点