Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy
Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy
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DOI：
10.1056/nejm199709113371102
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发表时间：
1997-09-11
影响因子：
158.5
通讯作者：
Chodakewitz, JA
中科院分区：
文献类型：
--
作者：
Gulick, RM;Mellors, JW;Chodakewitz, JA
新的蛋白酶抑制剂是人类免疫缺陷病毒（HIV）的有效抑制剂，与其他抗逆转录病毒药物联合使用，它们可能能够引起对HIV复制的深刻和持续的抑制。方法：在这项双盲研究中，97名接受齐多夫定治疗至少6个月，每立方毫米有50至400个CD4细胞和每毫升至少20,000个HIV RNA拷贝的HIV感染患者被随机分配到三种治疗方法中的一种，长达52周：每8小时800毫克英地那韦；每8小时200毫克齐多夫定联合150毫克拉米夫定，每天两次；或者三种药都有。对患者进行随访，监测不良事件的发生以及病毒载量和CD4细胞计数的变化。结果前24周，三药组HIV RNA的下降幅度大于其他两组（P < 0.001）。在第24周，三药组的31名患者中有28名（90%）的RNA水平下降到每毫升500拷贝以下，因地那韦组的28名患者中有12名（43%），齐多夫定-拉米夫定组的30名患者中没有。治疗前24周内，两组患者CD4细胞计数的增加均大于齐多维亚定-拉米夫定组（P均小于等于0.01）。病毒载量和CD4细胞计数的变化持续了52周。总的来说，所有的治疗方案都具有良好的耐受性。在大多数先前接受抗逆转录病毒治疗的HIV感染患者中，英地那韦、齐多夫定和拉米夫定联合治疗可将HIV RNA水平降低至每毫升500拷贝以下长达一年。(C) 1997年，马萨诸塞州医学会。
Background The new protease inhibitors are potent inhibitors of the human immunodeficiency virus (HIV), and in combination with other antiretroviral drugs they may be able to cause profound and sustained suppression of HIV replication.Methods In this double-blind study, 97 HIV-infected patients who had received zidovudine treatment for at least 6 months and had 50 to 400 CD4 cells per cubic millimeter and at least 20,000 copies of HIV RNA per milliliter were randomly assigned to one of three treatments for up to 52 weeks: 800 mg of indinavir every eight hours; 200 mg of zidovudine every eight hours combined with 150 mg of lamivudine twice daily; or all three drugs. The patients were followed to monitor the occurrence of adverse events and changes in viral load and CD4 cell counts.Results The decrease in HIV RNA over the first 24 weeks was greater in the three-drug group than in the other groups (P < 0.001 for each comparison). RNA levels decreased to less than 500 copies per milliliter at week 24 in 28 of 31 patients in the three-drug group (90 percent), 12 of 28 patients in the indinavir group (43 percent), and none of 30 patients in the zidovudine-lamivudine group. The increase in CD4 cell counts over the first 24 weeks was greater in the two groups receiving indinavir than in the zidoviadine-lamivudine group (P less than or equal to 0.01 for each comparison). The changes in the viral load and the CD4 cell count persisted for up to 52 weeks. All the regimens were generally well tolerated.Conclusions In most HIV-infected patients with prior antiretroviral therapy, the combination of indinavir, zidovudine, and lamivudine reduces levels of HIV RNA to less than 500 copies per milliliter for as long as one year. (C) 1997, Massachuselts Medical Society.