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首页> 美国卫生研究院文献>Antimicrobial Agents and Chemotherapy >Efficacy of Zidovudine Compared to Stavudine Both in Combination with Lamivudine and Indinavir in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine Stavudine or Protease Inhibitors (Novavir Trial)
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Efficacy of Zidovudine Compared to Stavudine Both in Combination with Lamivudine and Indinavir in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine Stavudine or Protease Inhibitors (Novavir Trial)

机译：齐多夫定与司他夫定相比与拉米夫定和茚地那韦联合使用对未免疫拉米夫定司他夫定或蛋白酶抑制剂的人免疫缺陷病毒感染核苷经历的患者的疗效（Novavir试验）

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We compared the efficacy and the toxicity of zidovudine (AZT) versus stavudine (d4T), in combination with lamivudine (3TC) and indinavir, in AZT-, dideoxyinosine (ddI)-, and/or dideoxycytosine (ddC)-experienced patients in a randomized comparative multicenter trial. One hundred seventy human immunodeficiency virus type 1 (HIV-1)-infected patients, who had received AZT, ddI, and/or ddC for at least 6 months but were naive for d4T, 3TC, and protease inhibitors, were randomized to AZT at 250 to 300 mg twice daily, 3TC at 150 mg twice daily, and indinavir at 800 mg every 8 h or to d4T at 40 mg twice daily, 3TC at 150 mg twice daily, and indinavir at 800 mg every 8 h. The primary endpoint was time to virological failure, defined as plasma HIV-1 RNA levels of >5,000 copies/ml after at least 8 weeks of antiretroviral therapy. Additional endpoints were change from baseline in CD4 cell counts, AIDS-defining events and adverse events, and proportion of patients with HIV-1 RNA levels of <500 copies/ml and HIV-1 RNA levels of <50 copies/ml. At week 80, 15 patients in the AZT arm and 14 patients in the d4T arm had reached the primary endpoint, and time to virological failure did not differ between the two arms (P = 0.98). In the d4T and in the AZT arms, 67 and 73% of patients, respectively, had HIV-1 RNA levels of <500 copies/ml (P = 0.50). The median change from baseline in CD4 cell count was 195 × 106 and 175 × 106/liter for the d4T- and AZT-containing arms, respectively. The proportions of patients with HIV-1 RNA levels of <50 copies/ml at weeks 8, 16, and 24 were similar in the two arms. The occurrence of serious adverse events was not significantly different between arms. In conclusion, in these patients heavily pretreated with AZT, switching from AZT to d4T when initiating indinavir and 3TC did not bring any additional benefit compared to maintaining AZT.
机译：我们比较了齐多夫定（AZT）与司他夫定（d4T）联合拉米夫定（3TC）和茚地那韦在AZT，双脱氧肌苷（ddI）和/或双脱氧胞嘧啶（ddC）经历的患者中的疗效和毒性随机比较多中心试验。接受AZT，ddI和/或ddC至少6个月但未接受d4T，3TC和蛋白酶抑制剂治疗的一百七十个人感染1型人类免疫缺陷病毒（HIV-1）的患者被随机分组​​接受AZT治疗每天两次250至300毫克，每天3次150毫克的3TC和每8小时800毫克的茚地那韦或每天两次40毫克的d4T，每天150毫克两次的3TC以及每8小时800毫克的茚地那韦。主要终点是病毒学失败的时间，定义为抗逆转录病毒治疗至少8周后血浆HIV-1 RNA水平> 5,000拷贝/ ml。其他终点是CD4细胞计数，定义艾滋病的事件和不良事件的基线水平和基线以下的变化，以及HIV-1 RNA水平<500拷贝/ ml和HIV-1 RNA水平<50拷贝/ ml的患者比例。在第80周时，AZT组的15例患者和d4T组的14例患者已达到主要终点，并且两组之间的病毒学衰竭时间无差异（P = 0.98）。在d4T和AZT组中，分别有67％和73％的患者的HIV-1 RNA水平<500拷贝/ ml（P = 0.50）。含d4T和AZT的手臂的CD4细胞计数相对于基线的中位变化分别为195×10 6 /升和175×10 6 /升。两组的第8、16和24周HIV-1 RNA水平<50拷贝/ ml的患者比例相似。两组之间严重不良事件的发生率没有显着差异。总之，在这些接受AZT大量治疗的患者中，与维持AZT相比，开始使用茚地那韦和3TC时从AZT转换为d4T并没有带来任何其他好处。

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