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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是NIH赞助的多中心协议。 假设：米诺环素治疗24周将改善与HIV相关的认知障碍，并且安全且耐受性良好。 主要目标：检查米诺环素治疗24周是否可以改善与HIV相关的认知障碍。 次要目标：检查与HIV相关的认知障碍患者的24周米诺环素治疗是否安全且耐受性良好。 检查米诺环素治疗48周是否在患有艾滋病毒相关的认知障碍的患者中安全且耐受性良好。 检查24周的米诺环素治疗是否会改善功能障碍。 检查24周的米诺环素治疗是否会降低与HIV相关的认知障碍的几种标记水平，包括但不限于HIV-1 RNA；免疫激活的标记，[单核细胞趋化剂蛋白（MCP-1）]；凋亡的标记（SFA）；在血液和脑脊液（CSF）中，氧化应激[神经酰胺，鞘磷脂，4-羟基诺纳尔（HNE）和3-硝基酪氨酸[3-NT]改性蛋白]。 检查米诺环素是否会降低阿扎那韦的血浆浓度。