Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures
Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures
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DOI：
10.1097/01.aids.0000166091.39317.99
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发表时间：
2005-04-29
期刊：
影响因子：
3.8
通讯作者：
Wilber, R
中科院分区：
文献类型：
--
作者：
Johnson, M;Grinsztejn, B;Wilber, R
目的：评价阿扎那韦/利托那韦 (ATV/RTV) (300/100 mg) 每日一次、阿扎那韦/沙奎那韦 (ATV/SQV) (400/1200 mg) 每日一次、洛匹那韦/利托那韦 (LPV/RTV) (400/100 mg) 每日两次，各联合替诺福韦 (300 mg) 每日一次和核苷逆转录酶抑制剂的治疗效果方法：对 358 名随机成人患者进行随机、开放、为期 48 周的多中心试验，这些患者之前接受过两种或多种 HAART 治疗方案失败，基线 HIV RNA >= 1000 拷贝/ml，CD4 细胞计数 >= 50 x 106 细胞/l。结果：主要疗效终点 [通过时间平均差 (TAD) 评估的血浆 HIV RNA 减少] 对于 ATV/RTV 和LPV/RTV [TAD 0.13； 48 周时，97.5% 置信区间，-0.12 至 0.39]。 ATV/RTV 和 LPV/RTV 相对于基线的平均减少量相当，分别为 1.93 和 1.87 log(10) 拷贝/ml。 ATV/RTV 和 LPV/RTV 的平均 CD4 细胞计数增加分别为 110 和 121 x 10(6) 细胞/升。从这两个参数来看，ATV/SQV 的功效均低于 LPV/RTV。 ATV/RTV 和 ATV/SQV 组总胆固醇和空腹甘油三酯的下降幅度大于 LPV/RTV 组（P
Objective: To evaluate atazanavir/ritonavir (ATV/RTV) (300/100mg) once daily, atazanavir/saquinavir (ATV/SQV) (400/1200 mg) once daily, and lopinavir/ritonavir (LPV/RTV) (400/100 mg) twice daily, each with tenofovir (300 mg) once daily and a nucleoside reverse transcriptase inhibitor in treatment-experienced HIV-infected patients.Methods: Randomized, open-label, 48-week multicenter trial of 358 randomized adult patients who had failed two or more prior HAART regimens with baseline HIV RNA >= 1000 copies/ml and CD4 cell count >= 50 x 106 cells/l.Results: The primary efficacy endpoint [plasma HIV RNA reduction assessed by time-averaged difference (TAD)] was similar for ATV/RTV and LPV/RTV [TAD 0.13; 97.5% confidence interval, -0.12 to 0.39] at 48 weeks. Mean reductions from baseline for ATV/RTV and LPV/RTV were comparable at 1.93 and 1.87 log(10) copies/ml, respectively. Mean CD4 cell count increases were 110 and 121 x 10(6) cells/l for ATV/RTV, and LPV/RTV, respectively. The efficacy of ATV/SQV was lower than LPV/RTV by both these parameters. Declines in total cholesterol and fasting triglycericles were greater with ATV/RTV and ATV/SQV than with LPV/RTV (P