Dataset from A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50
mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested
at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI
therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult
subjects.

本临床试验旨在评估每日一次给药50mg的GSK1349572，对比每日两次给药400mg的RAL（拉替拉韦，Raltegravir），在为期48周的疗程中的抗病毒活性非劣效性；同时亦将在第96周对其非劣效性进行验证。GSK1349572与RAL均将与固定剂量复方双核苷类反转录酶抑制剂（Nucleoside Reverse Transcriptase Inhibitors, NRTI）疗法（阿巴卡韦/拉米夫定[ABC/3TC]或替诺福韦酯/恩曲他滨[TDF/FTC]）联合给药。本研究的受试者为人类免疫缺陷病毒1型（HIV-1）感染且未接受过抗反转录病毒治疗（Antiretroviral Therapy, ART）的成年受试者。