通用名称

darunavir/cobicistat

儿科标签批准日期

2020/7/31 0:00:00

特定指示/秒

HIV-1 infection in pediatric patients weighing at least 40 kg

标签更改摘要

- Safety and effectiveness for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg was established through a trial with components of PREZCOBIX. - Use in this group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and virologic data from a study of components of PREZCOBIX (Trial GS-US-216-0128) in pediatric subjects with HIV-1 infection ages 12 to less than 18 years. - Safety and effectiveness of PREZCOBIX have not been established in pediatric patients weighing less than 40 kg. Darunavir, a component of PREZCOBIX is not recommended in pediatric patients below 3 years of age because of toxicity and mortality observed in juvenile rats dosed with darunavir.

治疗类别

AIDS & AIDS Related Drugs

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

3 MONTHS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic

研究设计

Multicenter,Open-Label

登记的患者

28

患者分析

N/A

中心的数量

7

国家数量

2

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

United States,Thailand