Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine
Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine
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DOI：
10.1056/nejm199604183341602
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发表时间：
1996-04-18
影响因子：
158.5
通讯作者：
Corey, L
中科院分区：
文献类型：
--
作者：
Collier, AC;Coombs, RW;Corey, L
背景。在人类免疫缺陷病毒（HIV）感染患者中，几种药物联合治疗可能会提高抗病毒治疗的效果。我们研究了HIV蛋白酶抑制剂沙奎那韦与一种或两种核苷类抗逆转录病毒药物联合使用的安全性和疗效，并与两种核苷类药物单独联合使用的安全性和疗效进行了比较。
方法。在这项双盲试验中，HIV感染患者被随机分配接受沙奎那韦（每天1800毫克）加上齐多夫定（每天600毫克）和扎西他滨（每天2.25毫克），或者齐多夫定加上沙奎那韦或扎西他滨。纳入的302名患者的CD4⁺细胞计数为每立方毫米50 - 300个细胞，且之前接受齐多夫定治疗的中位时间为27个月。该研究持续24周，另有可选择的双盲延长期12 - 32周。
结果。96%的患者完成了24周的研究。在所有三个治疗组中，CD4⁺细胞计数起初上升，然后逐渐下降。三药联合使用时CD4⁺细胞计数曲线下面积标准化值大于沙奎那韦和齐多夫定（P = 0.017）或扎西他滨和齐多夫定（P未完整给出）。
Background. In patients with human immunodeficiency virus (HIV) infection, combined treatment with several agents may increase the effectiveness of antiviral therapy. We studied the safety and efficacy of saquinavir, an HIV-protease inhibitor, given with one or two nucleoside antiretroviral agents, as compared with the safety and efficacy of a combination of two nucleosides alone.Methods. In this double-blind trial, patients with HIV infection were randomly assigned to receive either saquinavir (1800 mg per day) plus both zidovudine (600 mg per day) and zalcitabine (2.25 mg per day) or zidovudine plus either saquinavir or zalcitabine. The 302 patients enrolled had CD4+ counts of 50 to 300 cells per cubic millimeter and had previously received zidovudine for a median of 27 months. The study lasted 24 weeks, with an optional double-blind extension period of an additional 12 to 32 weeks.Results. Ninety-six percent of the patients completed the 24-week study. In all three treatment groups, CD4+ cell counts rose at first and then fell gradually. The normalized area under the curve for the CD4+ cell count was greater with the three-drug combination than with either saquinavir and zidovudine (P=0.017) or zalcitabine and zidovudine (P