A comparison of immediate with deferred zidovudine therapy for asymptomatic HIV-infected adults with CD4 cell counts of 500 or more per cubic millimeter. AIDS Clinical Trials Group.
A comparison of immediate with deferred zidovudine therapy for asymptomatic HIV-infected adults with CD4 cell counts of 500 or more per cubic millimeter. AIDS Clinical Trials Group.
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对 CD4 细胞计数为每立方毫米 500 或更多的无症状 HIV 感染成人进行立即治疗和延迟齐多夫定治疗的比较。
DOI：
10.1056/nejm199508173330701
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发表时间：
1995
期刊：
影响因子：
--
通讯作者：
Hirsch,MS
中科院分区：
文献类型：
--
作者：
Volberding,PA;Lagakos,SW;Grimes,JM;Stein,DS;Rooney,J;Meng,TC;Fischl,MA;Collier,AC;Phair,JP;Hirsch,MS
当CD4细胞计数超过500 /立方毫米时，齐多夫定对无症状人类免疫缺陷病毒（HIV）感染患者的临床益处尚未得到证实。我们比较了这些患者立即给予齐多夫定治疗和延期治疗。方法从1987年开始，无症状HIV感染者和每立方毫米CD4细胞500或更多的受试者随机分配接受安慰剂或齐多夫定（500或1500mg /天，立即开始）。1989年，这项研究进行了修改，当CD4细胞计数低于每立方毫米500个时，每天给予500毫克齐多夫定（延期治疗）的开放治疗。研究终点包括总生存期、无获得性免疫缺陷综合征（AIDS）生存期、毒性效应和CD4细胞计数变化。结果可评价对象1637例，延期治疗组547例，立即给予齐多夫定500 mg组549例，给予齐多夫定1500 mg组541例。受试者随访时间长达6.5年（组中位数分别为4.8、4.8和4.9年）。与低剂量组或高剂量组相比，延迟治疗组的无艾滋病生存期（分别为81例进展为艾滋病或死亡，分别为81例和74例；P = 0.95和P = 0.13）或总生存期（51例死亡，分别为47例和46例；P = 0.25和P = 0.16）无显著差异。两个立即治疗组的CD4细胞下降速度都比延迟治疗组慢（P<0.001）。不良反应不常见，在研究修改前，其发生率在治疗组之间相似，但1500 mg组的严重贫血和粒细胞减少症发生率高于延迟治疗组（P<0.001）。结论对于无症状、CD4细胞每立方毫米超过500个的hiv感染成人，齐多夫定治疗可以减缓CD4细胞计数的下降，但不能显著延长无艾滋病生存期或总生存期。这些结果不鼓励在这一人群中常规使用齐多夫定单药治疗。
BackgroundThe clinical benefits of zidovudine remain unproved in patients with asymptomatic human immunodeficiency virus (HIV) infection when CD4 cell counts exceed 500 per cubic millimeter. We compared zidovudine therapy given immediately with deferred therapy in such subjects.MethodsBeginning in 1987, subjects with asymptomatic HIV infection and 500 or more CD4 cells per cubic millimeter were randomly assigned to receive placebo or zidovudine (either 500 or 1500 mg per day, starting immediately). In 1989, the study was modified so that open-label treatment with 500 mg of zidovudine per day (deferred therapy) was offered when CD4 cell counts fell below 500 per cubic millimeter. The study end points included overall survival, survival free of the acquired immunodeficiency syndrome (AIDS), toxic effects, and changes in CD4 cell counts.ResultsThere were 1637 subjects who could be evaluated: 547 in the deferred-therapy group, 549 in the group receiving 500 mg of zidovudine immediately, and 541 in the 1500-mg group. The subjects were followed for up to 6.5 years (group medians, 4.8, 4.8, and 4.9, respectively). There was no significant difference in AIDS-free survival in the deferred-therapy group as compared with the low-dose or high-dose groups (81 cases of progression to AIDS or death vs. 81 and 74, respectively; P = 0.95 and P = 0.13) or in overall survival (51 deaths vs. 47 and 46; P = 0.25 and P = 0.16). The decline in CD4 cells was slower in both immediate-therapy groups than in the deferred-therapy group (P<0.001 for both). Adverse effects were uncommon, and before the study modification their incidence was similar among the treatment groups, but severe anemia and granulocytopenia were more frequent in the 1500-mg group than in the deferred-therapy group (P<0.001).ConclusionsIn asymptomatic, HIV-infected adults with 500 or more CD4 cells per cubic millimeter, treatment with zidovudine slows the decline in the CD4 cell count but does not significantly prolong either AIDS-free or overall survival. These results do not encourage the routine use of zidovudine monotherapy in this population.
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齐多夫定用于无症状 HIV 感染且 CD4 细胞计数大于 400 每立方毫米的患者
DOI：
--
发表时间：
1993
期刊：
影响因子：
--
作者：
D. Cooper;J. Gatell;S. Kroon;N. Clumeck;J. Millard;F. Goebel;J. Bruun;G. Stingl;R. Melville;J. González;J. Stevens;A. Fiddian
通讯作者：
A. Fiddian
临床试验中的替代终点。
影响因子：
--
作者：
S. Ellenberg
通讯作者：
S. Ellenberg
影响因子：
2
作者：
Lagakos,SW;Lim,LL;Robins,JM
通讯作者：
Robins,JM
大型、简单的试验在艾滋病治疗的评估中占有一席之地吗？
影响因子：
3.5
作者：
S. Ellenberg
通讯作者：
S. Ellenberg
影响因子：
158.5
作者：
KAHN, JO;LAGAKOS, SW;DOLIN, R
通讯作者：
DOLIN, R