TRIAL OF ABT-538 PLUS CURRENT THERAPY VS PLACEBO IN HIV PATIENTS

HIV-1蛋白酶是病毒编码的酶，是加工过程中所必需的 Gag-Poll-PolyProtein。抑制这种酶产生无污染的 未成熟的病毒粒子。艾滋病毒蛋白水解酶的特异性抑制剂ABT-538可能 预防新一轮艾滋病毒感染者的逆转录病毒感染。 该方案是一种双盲、随机、双臂、并行 艾滋病病毒感染者的多中心、多国家临床试验 CD_4细胞计数为100个/mm~3。符合条件的患者将收到 至少九个月以前用ZDV、ddi、ddC或d4T治疗。这 研究将比较ABT-538和口服安慰剂的剂量 在患者现有的核苷治疗中加入600毫克，每日2次(如果 任何)。将有大约700名患者入选，每支手臂350名。这个 研究的双盲阶段(4个月)将在191结束 患者经历了疾病的进展。此时，可选， 开启标签ABT-538将开始延续。

HIV-1 protease is the virus encoded enzyme necessary for the processing of the gag-pol-polyprotein. Inhibition of this enzyme yields nonfectious immature virions. ABT-538, a specific inhibitor of HIV protease, may prevent new rounds of retroviral infection in HIV-infected individuals. This protocol is a double blind, randomized, two arm, parallel, multicenter, multicountry, clinical trial in HIV infected patients with CD4 cell counts of <100 cells/mm3. Eligible patients will have received at least nine months of previous therapy with ZDV, ddI, ddC or d4T. This study will compare ABT-538 and placebo administered orally at a dose of 600 mg bid when added to the patient's existing nucleoside therapy (if any). About 700 patients will be enrolled, 350 per arm. The double-blind phase of the study (4 months) will terminate when 191 patients have experienced disease progression. At this time, optional, open label ABT-538 continuation will be initiated.