Lamivudine in combination with zidovudine stavudine, or didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial
Lamivudine in combination with zidovudine stavudine, or didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial
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DOI：
10.1097/00002030-199904160-00009
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发表时间：
1999-04-16
期刊：
影响因子：
3.8
通讯作者：
Pettinelli, C
中科院分区：
文献类型：
--
作者：
Kuritzkes, DR;Marschner, I;Pettinelli, C
目的：研究拉米夫定（3TC）联合齐多夫定（ZDV）、二腺苷（ddl）、司他夫定（d4T）的抗病毒活性。设计：随机、安慰剂对照、部分双盲、多中心研究。单位：成人艾滋病临床试验单位。患者：未接受治疗的hiv感染成人，200-600 × 10(6) CD4 T淋巴细胞/l。干预措施：患者被公开随机分配到d4T或ddl肢体，然后以盲法随机分配接受：d4T（80毫克/天），d4T加3TC（300毫克/天），或ZDV（600毫克/天）加3TC，并伴有匹配的安慰剂；或ddl（400毫克/天），ddl加3TC（300毫克/天），或ZDV（600毫克/天）加3TC，与安慰剂相匹配。21周后，分配到单药治疗组的患者增加了3TC。主要结局指标：第24周和第48周血浆HIV-1 RNA水平降低。结果：299例患者入组。24周后平均减少血浆hiv - 1 RNA拷贝/毫升基线0.49日志(10)(而单一疗法)和1.03日志(10)(而+ 3 tc; P = 0.001),和0.68日志(10)(ddl单一疗法)和0.82日志(10)(ddl + 3 tc, P > 0.22), 38周后平均减少1.08日志(10)(而+ 3 tc)和1.01日志(10)(ZDV + 3 tc)而四肢(P = 0.66),和0.94日志(10)(ddl + 3 tc)日志(10)和0.88 (ZDV + 3 tc; P = 0.70)的ddl。结论：3TC显著增强了d4T的病毒学效应，而ddl没有，在首次治疗的患者中，3TC加d4T产生的病毒学变化与3TC加ZDV相当。这些结果支持使用3TC与ZDV或d4T作为初始联合抗逆转录病毒治疗的组成部分。(C) 1999 Lippincott Williams & Wilkins。
Objective: To study the antiviral activity of lamivudine (3TC) plus zidovudine (ZDV), didanosine (ddl), or stavudine (d4T).Design: Randomized, placebo-controlled, partially double-blinded multicenter study.Setting: Adult AIDS Clinical Trials Units.Patients: Treatment-naive HIV-infected adults with 200-600 x 10(6) CD4 T lymphocytes/l.Interventions: Patients were openly randomized to a d4T or a ddl limb, then randomized in a blinded manner to receive: d4T (80 mg/day), d4T plus 3TC (300 mg/day), or ZDV (600 mg/day) plus 3TC, with matching placebos; or ddl (400 mg/day), ddl plus 3TC (300 mg/day), or ZDV (600 mg/day) plus 3TC, with matching placebo. After 21 weeks 3TC was added for patients assigned to the monotherapy arms.Main outcome measure: The reduction in plasma HIV-1 RNA level at weeks 24 and 48.Results: Two hundred ninety-nine patients were enrolled. After 24 weeks the mean reduction in plasma HIV-1 RNA copies/ml from baseline was 0.49 log(10) (d4T monotherapy) versus 1.03 log(10) (d4T plus 3TC; P = 0.001), and 0.68 log(10) (ddl monotherapy) versus 0.82 log(10) (ddl plus 3TC; P > 0.22), After 38 weeks the mean reduction was 1.08 log(10) (d4T plus 3TC) versus 1.01 log(10) (ZDV plus 3TC) in the d4T limb (P = 0.66), and 0.94 log(10) (ddl plus 3TC) versus 0.88 log(10) (ZDV plus 3TC; P = 0.70) in the ddl limb.Conclusions: 3TC added significantly to the virologic effects of d4T, but not ddl, in treatment-naive patients 3TC plus d4T produced virologic changes comparable to those of 3TC plus ZDV. These results support the use of 3TC with either ZDV or d4T as a component of initial combination antiretroviral therapy. (C) 1999 Lippincott Williams & Wilkins.