COMPARISON OF THE VIROLOGIC EFFICACY OF NULFINAVIR/DMP 266 IN COMBINATION

这是一项随机、部分双盲的三臂多中心研究。 在长期接触核苷的艾滋病毒感染者中进行试验。 符合资格的受试者是继续参加ACTG 302或303的参与者 他们最初分配的核苷疗法。 血浆HIV RNA为500拷贝/毫升的受试者，在基线时确认为 或在其监测阶段，将被随机分配到(1)2个RTI 奈非那韦(NFV)，(2)2个RTIS DMP-266，或(3)2个非FV DMP-266。 这项研究将部分失明，因为受试者将接受开放的- 标记逆转录酶抑制剂。学习治疗的时间为 计划至少48周。 血浆HIV RNA和500拷贝/毫升在基线水平的受试者将继续 接受他们目前的302/303核苷方案，在开放标签中服用 能力，只要艾滋病毒RNA的连续测定仍然存在&500 拷贝/毫升。延迟随机化的受试者队列将是 单独分析；对A部分主题的分析不依赖于 B部分受试者完成研究。

This study is a randomized, partially double-blind three, arm multicenter trial in HIV-infected subjects with long-term nucleoside exposure. Eligible subjects are participants in ACTG 302 or 303 who continue on their initially assigned nucleoside therapy. Subjects with plasma HIV RNA > 500 copies/ml, confirmed either at baseline or during their monitoring phase, will be randomized to (1) 2 RTIs + Nelfinavir (NFV), (2) 2 RTIs + DMP-266, or (3) 2 RTIs + NFV + DMP-266. The study will be partially blinded in that subjects will receive open- label reverse transcriptase inhibitors. The duration of study treatment is planned to be at least 48 weeks. Subjects with plasma HIV RNA < 500 copies/ml at baseline will continue to receive their current 302/303 nucleoside regimen, taken in an open-label capacity, as long as serial determinations of HIV RNA remain < 500 copies/ml. The cohort of subjects with delayed randomization will be analyzed separately; analysis of Part A subjects will not depend on completion of the study by the Part B subjects.