STUDY A5235: A PHASE II, RANDOMIZED, DOUBLE-BLIND STUDY OF MINOCYCLINE IN THE

研究 A5235：米诺环素的 II 期、随机、双盲研究

• 批准号: 8166560
• 负责人: DANIEL W NIXON
• 金额: $ 1.02万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166560
• 关键词: 3-nitrotyrosine; 4 hydroxynonenal; Apoptosis; Atazanavir; Blood; CCL2 gene; Ceramides; Cerebrospinal Fluid; Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Funding; Grant; HIV-1; Impaired cognition; Individual; Institution; Minocycline; Monocyte Chemoattractant Proteins; Oxidative Stress; Phase; Plasma; Proteins; Protocols documentation; RNA; Randomized; Research; Research Personnel; Resources; Source; Sphingomyelins; United States National Institutes of Health; functional disability; immune activation; 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. This is a NIH sponsored, multi-center protocol. Hypothesis: Minocycline treatment for 24 weeks will improve HIV-associated cognitive impairment and will be safe and well-tolerated. Primary Objective: To examine whether minocycline treatment for 24 weeks improves HIV-associated cognitive impairment. Secondary Objectives: To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment. To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment. To examine whether minocycline treatment for 24 weeks improves functional impairment. To examine whether minocycline treatment for 24 weeks decreases levels of several markers of HIV-associated cognitive impairment including, but not limited to, HIV-1 RNA; a marker of immune activation, [monocyte chemoattractant protein (MCP-1)]; a marker of apoptosis (sFas); markers of oxidative stress [ceramide, sphingomyelin, 4-hydroxynonenal (HNE), and 3-nitrotyrosine [3-NT] modified proteins] in blood and cerebrospinal fluid (CSF). To examine whether minocycline decreases the plasma concentration of atazanavir.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项由NIH赞助的多中心协议。 假设：米诺环素治疗24周将改善艾滋病毒相关的认知损害，并且将是安全和耐受性良好的。 主要目的：研究米诺环素治疗24周是否能改善HIV相关的认知功能障碍。 次要目标：研究米诺环素治疗HIV相关认知障碍患者24周是否安全且耐受性良好。检查米诺环素治疗48周对HIV相关认知障碍患者是否安全和耐受性良好。检查米诺环素治疗24周是否改善功能障碍。研究米诺环素治疗24周是否降低了HIV相关认知障碍的几个标志物的水平，这些标志物包括但不限于HIV-1RNA、免疫激活的标志物[单核细胞趋化蛋白(MCP-1)]、细胞凋亡的标志物(SFAS)、氧化应激的标志物[神经酰胺、神经鞘磷脂、4-羟基二十二烯(HNE)和3-硝基酪氨酸[3-NT]修饰蛋白]。观察米诺环素是否降低阿扎那韦的血药浓度。