Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: Final results of two randomized phase III trials
Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: Final results of two randomized phase III trials
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DOI：
10.1016/j.jinf.2012.05.008
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发表时间：
2012-10-01
影响因子：
28.2
通讯作者：
Zeinecker, Jennifer
中科院分区：
文献类型：
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作者：
Caseiro, Marcos M.;Nelson, Mark;Zeinecker, Jennifer
背景：Vicriviroc是一种新型HIV CCR5拮抗剂，在有治疗经验的受试者的II期试验中显示出显著的疗效和良好的耐受性，支持在III期研究中进一步评估。方法：在对两种抗逆转录病毒药物耐药的ccr5阳性hiv感染者中进行了两项相同的双盲安慰剂（PBO）对照试验。受试者随机接受vicriviroc 30 mg QD （N = 571）或PBO （N = 286）和开放标签优化背景治疗（OBT），其中含有>= 2种完全有效的抗逆转录病毒药物。主要终点是在OBT中使用3种有效药物的受试者百分比。受试者的百分比
Background: Vicriviroc, a novel HIV CCR5 antagonist, demonstrated significant efficacy and favorable tolerability in phase II trials in treatment-experienced subjects, supporting further evaluation in phase III studies.Methods: Two identical double-blind, placebo (PBO)-controlled trials in CCR5-tropic HIV-infected subjects with documented resistance to two antiretroviral classes were conducted. Subjects were randomized to vicriviroc 30 mg QD (N = 571) or PBO (N = 286) with open-label optimized background therapy (OBT) containing >= 2 fully active antiretroviral drugs. The primary endpoint was percentage of subjects with = 3 active drugs in the OBT. The percentage of subjects with