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

ABT-538 加当前治疗与安慰剂在 HIV 患者中的试验

• 批准号: 5224985
• 负责人: CERYL L BESCH
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5224985
• 关键词: 2'3' dideoxycytidine; 2'3' dideoxyinosine; HIV infections; antiAIDS agent; clinical research; clinical trials; human subject; human therapy evaluation; oral administration; protease inhibitor; zidovudine

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.

HIV-1蛋白酶是病毒编码的酶， gag-pol-polyprotein。 抑制这种酶产生非感染性 未成熟的病毒体。 ABT-538是HIV蛋白酶的特异性抑制剂， 预防艾滋病毒感染者新一轮的逆转录病毒感染。 该方案是一项双盲、随机、双臂、平行、 在HIV感染者中进行的多中心、多国临床试验， CD 4细胞计数<100个细胞/mm 3。 合格患者将接受 既往接受过至少9个月的ZDV、ddI、ddC或d4 T治疗。 这 研究将比较口服ABT-538和安慰剂， 600 mg bid，当添加到患者现有的核苷治疗中时（如果 任何）。 将招募约700名患者，每组350名。 研究的双盲期（4个月）将在191例受试者 患者经历了疾病进展。 此时，可选， 将开始开放标签ABT-538持续治疗。