ZIDOVUDINE PLUS INTERFERON-ALPHA VERSUS ZIDOVUDINE ALONE IN HIV-INFECTED SYMPTOMATIC OR ASYMPTOMATIC PERSONS WITH CD4+ CELL COUNTS GREATER-THAN-150X10(6)/I

DOI：

10.1097/00002030-199509000-00007

发表时间：

1995-09-01

期刊：

AIDS

影响因子：

3.8

通讯作者：

中科院分区：

医学2区

文献类型：

作者：

FERNANDEZCRUZ, E;LANG, JM;YEO, J

目的：评估齐多夫定 (ZDV) 和淋巴母细胞干扰素 (IFN)-α 联合治疗与 ZDV 单药治疗相比，在 CD4+ 细胞计数在 150 至 500 x 10(6)/l 之间的 HIV 感染受试者中的疗效和安全性。设计：开放、随机对照试验，受试者按美国疾病控制与预防中心 (CDC) 1986 年 HIV 疾病分类（II/III 或 IV 组）进行分层。该研究于 1992 年 2 月修改为序贯设计，以便进行中期分析。地点：欧洲、澳大利亚和加拿大 45 家医院的门诊诊所。参与者：总共 402 名先前未经治疗的有症状 HIV 感染者（CDC IV 组）且 CD4+ 计数为 150-500x10(6)/l 或无症状 HIV 感染者（CDC II/III 组）且 CD4+ 计数的受试者150-350 x 10(6)/l。干预措施：ZDV 250 mg，每天两次，伴或不伴 3 MU 皮下注射淋巴母细胞 IFN-α，每周 3 次。主要结果指标：达到研究终点的时间，定义为：从 CDC II/III 组进展到 IV 组，IV 组非 AIDS 进展到 AIDS，或 IV 组 AIDS 进展到第二种 AIDS 定义条件； CD4+也算

Objective: To evaluate the efficacy and safety of zidovudine (ZDV) and lymphoblastoid interferon (IFN)-alpha combination therapy compared with ZDV monotherapy in HIV-infected subjects with CD4+ cell counts between 150 and 500 x 10(6)/l.Design: Open, randomized controlled trial with subjects stratified by the Centers for Disease Control and Prevention (CDC) 1986 classification of HIV disease (group II/III or IV). The study was amended to a sequential design in February 1992 to allow interim analyses to be conducted.Setting: Outpatient clinics in 45 hospitals in Europe, Australia and Canada.Participants: A total of 402 previously untreated subjects with symptomatic HIV infection (CDC group IV) and CD4+ count 150-500x10(6)/l or asymptomatic HIV infection (CDC group II/III) with CD4+ count 150-350 x 10(6)/l.Interventions: ZDV 250 mg twice daily with or without 3 MU subcutaneous injections of lymphoblastoid IFN-alpha three times per week.Main outcome measures: Time to development of a study endpoint defined as: progression from CDC group II/III to group IV, group IV non-AIDS to AIDS, or group IV AIDS to a second AIDS-defining condition; also CD4+ count to

ZIDOVUDINE PLUS INTERFERON-ALPHA VERSUS ZIDOVUDINE ALONE IN HIV-INFECTED SYMPTOMATIC OR ASYMPTOMATIC PERSONS WITH CD4+ CELL COUNTS GREATER-THAN-150X10(6)/I - RESULTS OF THE ZIDON TRIAL

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