Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 Versus Optimized Background Regimen Only 1 and 2 clinical trials
Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 Versus Optimized Background Regimen Only 1 and 2 clinical trials
复制标题
DOI：
10.1097/01.qai.0000185314.56556.c3
复制
发表时间：
2005-12-01
影响因子：
3.6
通讯作者：
Salgo, MP
中科院分区：
文献类型：
--
作者：
Nelson, M;Arastéh, K;Salgo, MP
背景：T-20 与仅优化背景方案 (TORO) I 和 TORO 2 临床试验是开放标签、对照、平行组、3 期研究，在经历过治疗的 HIV-1 感染患者中比较恩夫韦肽加抗逆转录病毒药物优化背景 (OB) (n = 661) 与单独 OB (n = 334)。 方法：第 48 周的主要目标是调查 疗效，以第 24 周维持反应或改善的患者百分比来衡量。疗效分析使用意向治疗人群。结果：随机分配到恩夫韦肽组的总共 73.7% 的患者在第 48 周仍继续接受治疗，而最初随机分配到对照组的患者为 21.3%。在第 48 周，在每个应答者类别中，恩夫韦肽组中第 24 周应答者维持应答或成为新应答者的比例高于对照组：HIV-1 RNA 水平相对于基线的变化 >= 1.0 log(10)，
Background: The T-20 Versus Optimized Background Regimen Only (TORO) I and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretroviral s (n = 661) with OB alone (n = 334) in treatment-experienced HIV-1-infected patients.Methods: The primary objective at week 48 was to investigate durability of efficacy, as measured by the percentage of patients maintaining their week 24 response or improving. Efficacy analyses used the intent-to-treat population.Results: A total of 73.7% of patients randomized to the enfuvirtide group remained on treatment through week 48 versus 21.3% originally randomized to the control group. At week 48, a higher proportion of week 24 responders maintained their response or were new responders in the enfuvirtide group than in the control group in each responder category: HIV-1 RNA level >= 1.0 log(10) change from baseline,