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: 6245455
• 负责人: NED SAKTOR
• 金额: $ 2.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-05 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6245455
• 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

This study evaluates the safety and efficacy of the Glaxo-Wellcome drug, 1592U89, (abacavir), in combination with other approved anti-retroviral agents in patients with HIV dementia. It is a randomized, double-blind, placebo-controlled multi-center study, enrolling approximately 90 patients. Patients are recruited from the Johns Hopkins AIDS Clinic or from direct referral to the HIV Neurology Consultation Service. Informed, witnessed, signed consent is obtained from all participants or from the person with durable power of attorney. The double-blind, placebo-controlled phase of the study is 12 weeks. After this phase, patients will be eligible to receive 40 weeks of open label 1592U89 200 mg every 8 hours. Evaluations include neurological and neuro- psychological assessments, concurrent medications, concurrent AIDS- defining illnesses, adverse experiences, activities of daily living assessment, routine safety labs, lymphocyte subset, and plasma virology. The primary efficacy measure is the comparison of standardized neuropsychological tests between standard therapy with and without concurrent 1592U89 therapy. Safety analyses will examine adverse experiences, clinical laboratory abnormalities and vital signs over time. To date, 6 subjects are in the double-blind, placebo-controlled phase of the study, and 2 subjects are in the pre-screen phase of the study (1 subject was screened and did not meet criteria). No significant adverse events have occurred. Efficacy evaluations are currently in progress.

这项研究评估了葛兰素 - 孔隙药物的安全性和功效， 1592U89，（Abacavir），结合其他批准的抗逆转录病毒 HIV痴呆症患者的药物。 这是一个随机的双盲， 安慰剂控制的多中心研究，约90个 患者。 患者是从约翰·霍普金斯艾滋病诊所招募的 从直接推荐到HIV神经病学咨询服务。 从所有参与者那里获得了知情，见证，已签署的同意 或来自具有持久授权书的人。 双盲， 该研究的安慰剂对照阶段为12周。 在此阶段之后， 患者有资格获得40周的开放标签1592U89 200 每8小时毫克。 评估包括神经和神经 - 心理评估，并发药物，并发艾滋病 - 定义疾病，不利经历，日常生活活动 评估，常规安全实验室，淋巴细胞子集和血浆病毒学。 主要功效措施是标准化的比较 有和没有的标准疗法之间的神经心理测试 并发1592U89治疗。 安全分析将检查不利 经验，临床实验室异常和生命体征 时间。 迄今为止，有6个受试者是双盲，安慰剂对照 研究的阶段和2个受试者处于屏幕前阶段 研究（对1个受试者进行了筛选，不符合标准）。 不 发生了重大不良事件。 功效评估是 目前正在进行中。