A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter

A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter
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DOI:
10.1056/nejm199610103351501
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发表时间:
1996-10-10
影响因子:
158.5
通讯作者:
Salgo, M
Salgo, M
中科院分区:
医学1区
文献类型:
--
作者:
Hammer, SM;Katzenstein, DA;Salgo, M

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背景这项双盲研究评估了用单个核苷或两个核苷的治疗,在感染了人类免疫缺陷病毒1型(HIV-1)的成年人中,其CD4细胞计数从200至500毫米。每天四种方案之一:600 mg Zidovudine的1例感染患者(未经抗逆转录病毒治疗的43%); 600毫克的Zidovudine加400毫克的狄烷酮; 600毫克的Zidovudine加2.25毫克Zalcitabine;或400毫克的狄烷酮。主要终点大于或等于50%的CD4细胞计数,获得的免疫缺陷综合征(AIDS)的发展或死亡。单独使用Zidovudine(32%)的重新进展到主要终点更为频繁(32%)。比Zidovudine Plus Didanosine(18%;相对危险比,0.50; P
Background This double-blind study evaluated treatment with either a single nucleoside or two nucleosides in adults infected with human immunodeficiency virus type 1 (HIV-1) whose CD4 cell counts were from 200 to 500 per cubic millimeter.Methods We randomly assigned 2467 HIV-1-infected patients (43 percent without prior antiretroviral treatment) to one of four daily regimens: 600 mg of zidovudine; 600 mg of zidovudine plus 400 mg of didanosine; 600 mg of zidovudine plus 2.25 mg of zalcitabine; or 400 mg of didanosine. The primary end point was a greater than or equal to 50 percent decline in the CD4 cell count, development of the acquired immunodeficiency syndrome (AIDS), or death.Results Progression to the primary end point was more frequent with zidovudine alone (32 percent) than with zidovudine plus didanosine (18 percent; relative hazard ratio, 0.50; P