通用名称

maraviroc

儿科标签批准日期

2020/10/30 0:00:00

特定指示/秒

Treatment of HIV-1 infection in children from birth to 2 years and dosing recommendations for pediatric patients weighing 10 kg to less than 30 kg

标签更改摘要

- The recommendation of Selzentry for the treatment of HIV-1 infection in neonates from birth to 6 weeks is based on safety and pharmacokinetic data obtained from clinical trial IMPAACT P2007. - In IMPAACT P2007, the safety and pharmacokinetic profiles of Selzentry were evaluated in 38 full-term HIV-1–exposed neonates (born to HIV-1–infected mothers) from birth through 6 weeks. - There are insufficient data to make dosing recommendations for use of Selzentry in pediatric patients concomitantly receiving potent CYP3A inhibitors and weighing less than 10 kg, or in any pediatric patients concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor. - Selzentry is not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg.

治疗类别

Antivirals

立法类型

BPCA Only

产品说明书链接

书号

1.0

研究年龄

0 DAYS - 3 DAYS

学习类型

Safety,Pharmacokinetic

研究设计

Multicenter,Open-Label,Phase 1,Intensive PK

登记的患者

47

患者分析

47

中心的数量

9

国家数量

4

西班牙裔拉美裔/拉丁裔总计

5

非西班牙裔/非拉丁裔总人数

42

总数#种族不明

0

亚裔学生总数

3

黑人总数

38

白人总数

6

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

0

其他种族总计

0

未知种族总数

0

国家

United States,Kenya,South Africa,Thailand