PHASE III MULTICENTER TRIAL OF SAFETY AND EFFICACY OF 1592U89 IN HIV DEMENTIA

1592U89 治疗 HIV 痴呆的安全性和有效性的 III 期多中心试验

• 批准号: 6297512
• 负责人: NED SAKTOR
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6297512
• 关键词: 2'3' dideoxynucleoside; AIDS dementia complex; AIDS therapy; antiAIDS agent; clinical research; drug screening /evaluation; human subject; human therapy evaluation; neuropsychological tests; reverse transcriptase inhibitors

The study evaluates the safety and efficacy of 1592U89 (abacavir) in patients with HIV dementia. The study is a randomized, double-blind, placebo-controlled multicenter study, conducted at several centers in the United States, United Kingdom, Holland, and Australia. The study enrolled approximately 90 patients, The double-blind, placebo controlled phase of the study is 12 weeks. After this phase, patients are eligible to receive 40 weeks of open label 1592U89 600 mg every 12 hours followed by the option to extend open-label 1592U89 indefinitely. Screening, baseline, and maintenance evaluations include: medical and neurological history including AIDS defining diseases, physical examination, neurological and neuropsychological assessments, dementia severity rating, concomitant medication assessment, head MRI, laboratory tests including routine safety labs (plasma and urinalysis), pregnancy screen, plasma virology and lumbar puncture for routine CSF analysis, cultures, immunological markers, and virology.

该研究评估了1592U89（Abacavir）在 HIV痴呆症患者。 该研究是一项随机，双盲的 安慰剂控制的多中心研究，在几个中心进行 美国，英国，荷兰和澳大利亚。 研究 注册了约90名患者，双盲，安慰剂 研究的受控阶段为12周。 在此阶段之后，患者 有资格获得40周的打开标签1592U89 600毫克每12毫克 小时之后是无限期扩展开放标签1592U89的选项。 筛查，基线和维护评估包括：医疗和 神经病史，包括定义疾病的艾滋病，身体 检查，神经和神经心理学评估，痴呆症 严重程度评级，伴随药物评估，Head MRI，实验室 包括常规安全实验室（血浆和尿液分析），怀孕的测试 筛查，血浆病毒学和腰椎穿刺，用于常规CSF分析， 文化，免疫标记和病毒学。