A PHASE 2B/3, RANDOMIZED, DOUBLE-BLIND, DOSE CONFIRMING STUDY OF THE SAFETY,

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 联合抗逆转录病毒疗法(ART)的出现大大降低了与艾滋病毒疾病相关的发病率和死亡率。然而，许多在治疗后达到无法检测到的血浆HIV-1RNA水平的患者最终经历了病毒学失败，需要改变他们的ART。显然需要更新的药物，特别是那些对现有药物具有抗药性的病毒分离株的药物，以扩大可用于治疗艾滋病毒-1感染患者的产品的武器库。核苷逆转录酶抑制剂(NRTI)是目前控制HIV-1感染策略的重要组成部分。一种新的耐受性良好的胞苷类似物具有更好的耐药性、有效性和安全性，将大大增加治疗经验丰富的HIV-1感染患者的治疗选择。该研究的目的是比较ATC和拉米夫定(3TC)对逆转录酶M184V/I突变的HIV-1感染患者的抗逆转录病毒疗效。比较ATC和拉米夫定(3TC)治疗HIV-1感染患者的安全性和耐受性。患者将被随机分配到3个ARM中的一个，以1：1：1的比例接受最长48周的治疗： 答：阿普利他滨800毫克，每日2次(加拉米夫定安慰剂)，口服 B组：阿普利他滨1200 mg，每日2次(加拉米夫定安慰剂)，口服 C：拉米夫定150毫克，每日2次(加安慰剂)，口服 这项研究将有助于确定这种治疗方案是否有效。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The advent of combination antiretroviral therapy (ART) has significantly decreased the morbidity and mortality associated with HIV disease. However, many patients who achieve undetectable plasma HIV-1 RNA levels following treatment ultimately experience virologic failure requiring a change in their ART. Newer agents, particularly those with activity against viral isolates with resistance to currently available drugs, are clearly needed in order to extend the armory of products available to treat patients with HIV-1 infection. The nucleoside reverse transcriptase inhibitors (NRTIs) are important components of the current strategies to control HIV-1 infection. A new, well tolerated cytidine analog with an improved resistance, efficacy and safety profile would make a substantial addition to the therapeutic options for treatment experienced patients with HIV-1 infection. The objective of the study is to compare the antiretroviral efficacy of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients with the M184V/I mutation in reverse transcriptase.? To compare the safety and tolerability of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients. Patients will be randomized to one of 3 Arms to receive for up to 48 weeks in a 1:1:1 ratio: A: apricitabine 800mg BID (plus lamivudine placebo), orally B: apricitabine 1200mg BID (plus lamivudine placebo), orally C: lamivudine 150mg BID (plus apricitabine placebo), orally This study will help determine if this treatment option is effective.