The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naive HIV-1-infected patients
The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naive HIV-1-infected patients
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DOI：
10.1310/hct0803-164
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发表时间：
2007-05-01
影响因子：
--
通讯作者：
Enejosa, Jeffrey
中科院分区：
文献类型：
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作者：
Cassetti, Isabel;Madruga, Jose Valdez R.;Enejosa, Jeffrey
背景资料：研究903是一项III期试验，包括一个已完成的144周双盲期，比较替诺福韦DF（TDF）与司他夫定（d4 T）联合拉米夫定（3 TC）和依法韦仑（EFV），以及一个正在进行的额外的336周开放标签扩展期。方法：巴西、阿根廷和多米尼加共和国完成144周双盲期TDF治疗的患者有资格转入扩展期（第144-480周）。提供了中期第288周分析的结果。结果如下：最初随机分配至TDF组的86名患者（62%男性，70%白色）继续接受TDF治疗。在144周双盲期结束时，86名患者中有85名携带HIV-1 RNA
Background: Study 903 is a phase 3 trial with a completed 144-week, doubleblind phase comparing tenofovir DF (TDF) to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) and an ongoing additional 336-week open-label extension phase. Method: Patients in Brazil, Argentina, and the Dominican Republic who completed the 144-week double-blind phase on TDF were eligible to roll over to the extension phase (weeks 144-480). Results from an interim week 288 analysis are presented. Results: Eighty-six patients (62% male, 70% white) initially randomized to the TDF arm continued treatment with TDF At the end of the 144-week, doubleblind phase, 85 of the 86 had HIV-1 RNA