Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease
Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease
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DOI：
10.1016/s0140-6736(97)04161-5
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发表时间：
1998-02-21
期刊：
影响因子：
168.9
通讯作者：
Leonard, J
中科院分区：
文献类型：
--
作者：
Cameron, DW;Heath-Chiozzi, M;Leonard, J
利托那韦是一种有效的、口服生物可利用的HIV-1蛋白酶抑制剂。我们在HIV-1感染和CD 4-淋巴细胞计数≤ 100个细胞/μ L的患者中进行了一项利托那韦的国际、多中心、随机、双盲、安慰剂对照试验，方法将1090例患者随机分为口服利托那韦600 mg（n=543）和安慰剂（n=547）两组。同时继续使用最多两种许可的核苷药物治疗。主要研究结果是任何首次新发或特定复发的AIDS定义事件或死亡。开放标签利托那韦16周后，在研究中提供给任何患者谁有艾滋病定义events.Findings的基线中位CD 4-淋巴细胞计数为18（IQR 10-43）/μ L利托那韦组和22（10-47）/μ L安慰剂组。利托那韦组114例（21.1%）患者和安慰剂组45例（8.3%）患者主要由于初始不良症状而停用研究药物。利托那韦组119例（21.9%）和安慰剂组205例（37.5%）患者发生AIDS定义疾病或死亡结局（风险比0.53 [95%CI 0.42-0.66];对数秩和检验P <0.05）。
Background Ritonavir is a potent, orally bioavailable inhibitor of HIV-1 protease. We undertook an international, multicentre, randomised, double-blind, placebo-controlled trial of ritonavir in patients with HIV-1 infection and CD4-lymphocyte counts of 100 cells/mu L or less, who had previously been treated with antiretroviral drugs.Methods 1090 patients were randomly assigned twice-daily liquid oral ritonavir 600 mg (n=543) or placebo (n=547) while continuing treatment with up to two licensed nucleoside agents. The primary study outcome was any first new, or specified recurrent, AIDS-defining event or death. Open-label ritonavir was provided after 16 weeks in the study to any patient who had an AIDS-defining event.Findings The baseline median CD4-lymphocyte count was 18 (IQR 10-43)/mu L in the ritonavir group and 22 (10-47)/mu L in the placebo group. Study medication was discontinued in 114 (21.1%) ritonavir-group patients and 45 (8.3%) placebo-group patients mainly because of initial adverse symptoms. Outcomes of AIDS-defining illness or death occurred in 119 (21.9%) ritonavir-group patients and 205 (37.5%) placebo-group patients (hazard ratio 0.53 [95% CI 0.42-0.66]; log-rank p