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的一个 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。 这是一个NIH赞助的多中心方案。 假设：米诺环素治疗24周将改善HIV相关的认知障碍，并且安全且耐受性良好。 主要目的： 研究二甲胺四环素治疗24周是否能改善HIV相关的认知功能障碍。 次要目的：研究米诺环素治疗24周对HIV相关认知障碍患者是否安全且耐受良好。 研究二甲胺四环素治疗48周是否安全，对HIV相关认知障碍患者的耐受性是否良好。 研究米诺环素治疗24周是否改善功能障碍。 检测米诺环素治疗24周是否降低了HIV相关认知障碍的几种标志物的水平，包括但不限于HIV-1 RNA;免疫活化标志物[单核细胞趋化蛋白（MCP-1）];凋亡标志物（sFas）;血液和脑脊液（CSF）中的氧化应激标志物[神经酰胺、鞘磷脂、4-羟基壬烯醛（HNE）和3-硝基酪氨酸[3-NT]修饰蛋白]。 检测米诺环素是否降低阿扎那韦的血药浓度。