Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents
Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents
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DOI：
10.1097/qad.0b013e328330abaa
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发表时间：
2009-09-24
期刊：
影响因子：
3.8
通讯作者：
Spinosa-Guzman, Sabrina
中科院分区：
文献类型：
--
作者：
Blanche, Stephane;Bologna, Rosa;Spinosa-Guzman, Sabrina
目的：评估地瑞那韦/利托那韦（DRV/r）和优化背景方案在有治疗经验患者中的药代动力学、安全性和疗效设计：48周，开放标签，两部分，II期研究。（1：1比例）接受体重调整的成人等效剂量（A组）或每日两次（b.i.d.）B组。药代动力学，安全性和有效性进行了评估后，2周给药（第一部分），确定第二部分的剂量（评估48周的安全性和有效性）。结果：在第一部分，两组符合方案规定的标准，药代动力学和表现出良好的耐受性和有效性。选择以下体重剂量：DRV/r 375/50 mg b.i.d.（20-
Objective: To assess pharmacokinetics, safety and efficacy of darunavir/ritonavir (DRV/r) and optimized background regimen in treatment-experienced patients (6-17 years).Design: Forty-eight-week, open-label, two-part, phase II study.Methods: In part I, 44 patients were randomized (1 : 1 ratio) to receive a body weight-adjusted, adult-equivalent dose (group A) or a 20-33% higher DRV/r twice daily (b.i.d.) dose (group B). Pharmacokinetics, safety and efficacy were assessed following 2-week dosing (part I), which determined dosing for part II (evaluated 48-week safety and efficacy).Results: In part I, both groups met the protocol-specified criteria for pharmacokinetics and showed favorable tolerability and efficacy. The following body-weight doses were selected: DRV/r 375/50 mg b.i.d. (20-