CLINICAL TRIAL: A5235 - MINOCYCLINE IN THE TREATMENT OF HIV-ASSOCIATED COGNITIVE

临床试验：A5235 - 米诺环素治疗 HIV 相关认知障碍

• 批准号: 7716911
• 负责人: DAVID A WOHL
• 金额: $ 0.3万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716911
• 关键词: Anti-Retroviral Agents; Clinical Trials; Cognitive; Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Funding; Grant; HIV-1; Hour; Impaired cognition; Impairment; Institution; Label; Methods; Minocycline; Neurocognitive; Participant; Phase; Placebos; Procedures; Purpose; Randomized; Research; Research Personnel; Resources; Source; Treatment Protocols; United States National Institutes of Health; Upper arm; Week; improved

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: To examine whether Minocycline treatment for 24 weeks improves HIV-associated cognitive impairment. Participants: 100 subjects (50 subjects per arm) who are HIV-1 infected and are on a stable antiretroviral regimen with progressive neurocognitive impairment. Procedures (methods): Step 1: Double-Blind At entry, subjects will be randomized to one of two arms in the 24-week double-blind phase. Arm 1: Minocycline 100 mg, orally every 12 hours. Arm 2: Matching placebo, orally every 12 hours. Step 2: Open-Label Subjects who complete the 24-week double-blind phase (Step 1) will be offered the option to enter Step 2 and participate in the open-label minocycline phase for an additional 24 weeks. The open-label participation is optional. Minocycline 100 mg, orally every 12 hours.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目的：检测米诺环素治疗24周是否改善HIV相关的认知功能障碍。 参会人员：100例受试者（每组50例受试者），HIV-1感染，正在接受稳定的抗逆转录病毒治疗方案，伴有进行性神经认知障碍。 程序（方法）： 第1步：双盲入组时，受试者将被随机分配至24周双盲期的两个治疗组之一。 第1组：米诺环素100 mg，每12小时口服一次。 第2组：匹配安慰剂，每12小时口服一次。 第二步：完成24周双盲期（第1步）的开放标签受试者将可选择进入第2步并参加额外24周的开放标签米诺环素治疗期。开放标签参与是 可选的. 米诺环素100 mg，每12小时口服一次。