Open-label study of a twice-daily indinavir 800-mg/ritonavir 200-mg regimen in HIV-infected adults failing a protease inhibitor regimen.
Open-label study of a twice-daily indinavir 800-mg/ritonavir 200-mg regimen in HIV-infected adults failing a protease inhibitor regimen.
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对蛋白酶抑制剂治疗失败的 HIV 感染成人患者进行每日两次茚地那韦 800 毫克/利托那韦 200 毫克治疗方案的开放标签研究。
DOI：
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发表时间：
2002
期刊：
影响因子：
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通讯作者：
R. Zeldin
中科院分区：
文献类型：
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作者：
H. Katner;D. Paár;J. Nadler;E. Jensen;H. Wilson;Tyler S. Finn;R. Petruschke;R. Zeldin
对于蛋白酶抑制剂（PI）抗逆转录病毒治疗失败的HIV感染患者没有标准治疗。这项开放标签、非比较性24周研究（含24周扩展期）评价了茚地那韦/利托那韦800/200 mg每日两次加2种核苷逆转录酶抑制剂（NRTI）在该人群中的疗效、安全性和耐受性。以下是24周研究的结果。患者为既往病毒RNA（vRNA）抑制（<400拷贝/mL），随后抗逆转录病毒治疗失败（>或=400和<或= 100，000拷贝/mL），并且至少有一种新的NRTI可用于治疗的HIV感染成人。使用广义估计方程（GEE）或将未完成者计数为失败（NC = F），使用观察数据（DAO）和意向治疗（ITT）模型分析血浆vRNA <400和<50拷贝/mL的患者比例。使用DAO和ITT混合模型方法评价vRNA和CD 4细胞计数较基线的平均变化。入组了63例患者（87%为男性），平均年龄为42岁，平均基线vRNA和CD 4细胞计数分别为3.8 log（10）拷贝/mL和360个细胞/mm（3）。比例在第24周达到vRNA <400和<50拷贝/mL的患者中，对于DAO，分别为61%、87%和50%（35%、65%）;对于GEE，分别为64%、50%、75%和43%（30%、56%）;对于NC = F，分别为56%、43%、68%和37%（25%、50%）。在第24周，基线vRNA降低>1.0 log（10）拷贝/mL，CD 4细胞计数增加约90个细胞/mm（3）。3名患者（5%）发生了严重的药物相关不良事件。7例患者（11%）由于临床或实验室不良事件而停止治疗。在这项研究中，茚地那韦/利托那韦800/200 mg +2种NRTI的增强型每日两次方案在许多含PI方案失败的患者中抑制了HIV，并且通常耐受良好。
There is no standard treatment of HIV-infected patients who fail protease inhibitor (PI)-containing antiretroviral therapy. This open-label, noncomparative 24-week study with a 24-week extension evaluated the efficacy, safety, and tolerability of twice-daily indinavir/ritonavir 800/200 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) in this population. Presented here are the results of the 24-week study. Patients were HIV-infected adults who had prior viral RNA (vRNA) suppression (<400 copies/mL), subsequent failure (> or =400 and < or =100,000 copies/mL) on antiretroviral therapy, and at least one new NRTI available for treatment. The proportions of patients achieving plasma vRNA <400 and <50 copies/mL were analyzed with data as observed (DAO) and intention-to-treat (ITT) models using generalized estimating equations (GEE) or counting noncompleters as failures (NC = F). Mean changes from baseline in vRNA and CD4 cell count were evaluated using DAO and an ITT mixed-model approach. Sixty-three patients (87% male) with a mean age of 42 years and mean baseline vRNA and CD4 cell counts of 3.8 log(10) copies/mL and 360 cells/mm(3), respectively, were enrolled. The proportion (95% confidence interval) of patients achieving vRNA <400 and <50 copies/mL at week 24 were 76% (61%, 87%) and 50% (35%, 65%) for DAO, 64% (50%, 75%) and 43% (30%, 56%) for GEE, and 56% (43%, 68%) and 37% (25%, 50%) for NC = F, respectively. At Week 24, baseline vRNA decreased by >1.0 log(10) copies/mL and CD4 cell counts increased by approximately 90 cells/mm(3). Three patients (5%) experienced serious drug-related adverse events. Seven patients (11%) discontinued treatment due to clinical or laboratory adverse events. In this study, the enhanced, twice-daily regimen of indinavir/ritonavir 800/200 mg plus 2 NRTIs provided suppression of HIV in many patients who had failed a PI-containing regimen and was generally well tolerated.