ENTRY OF STAVUDINE INTO CEREBROSPINAL FLUID OF HIV INFECTED SUBJECTS

将司他夫定进入 HIV 感染者的脑脊液中

• 批准号: 6274547
• 负责人: ROB R MCGREGOR
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274547
• 关键词: AIDS therapy; HIV infections; cerebrospinal fluid; clinical research; clinical trial phase I; drug screening /evaluation; helper T lymphocyte; human subject; human therapy evaluation; lumbar puncture; pharmacokinetics; stavudine

Stavudine is a potent HIV-1 reverse transcriptase inhibitor licensed in 1994. No systematic evaluation of cerebrospinal fluid stavudine concentrations has been reported, either for single doses or under steady-state conditions. Improved understanding of stavudine penetration into CSF is important because of the desire for adequate inhibitory concentrations in the central nervous system to suppress HIV replication and hopefully to prevent or slow the development of the AIDS dementia complex. This protocol will examine the concentrations of stavudine (d4T) in cerebrospinal fluid (CSF) of HIV-infected subjects undergoing elective lumbar punctures (LP). Two groups of subjects will be studied: 1) those prescribed stavudine for clinical considerations, who will provide insight into CSF concentrations achieved under steady-state conditions; 2) those not receiving stavudine clinically, but agreeing to take a single dose prior to a scheduled LP, who will provide information on acute dynamics. This study will also determine whether or not a relationship exists between patient CD4 cell concentration and efficiency of CSF stavudine entry and whether or not a relationship exists between CSF white cell concentration or total protein and the efficiency of CSF stavudine entry.

司他夫定是一种有效的HIV-1逆转录酶抑制剂， 1994.未对脑脊液司他夫定进行系统评价 已报告浓度，无论是单次给药或 稳态条件。提高对司他夫定渗透性的认识 由于需要足够的抑制剂， 在中枢神经系统中的浓度，以抑制艾滋病毒复制 希望能预防或减缓艾滋病痴呆症的发展 复杂. 本方案将检查司他夫定（d4 T）在 接受择期手术的HIV感染者的脑脊液（CSF） 腰椎穿刺（LP）。 将研究两组受试者：1） 那些出于临床考虑而开司他夫定的人，他们将提供 了解稳态条件下达到的CSF浓度; 2)那些没有接受司他夫定临床，但同意采取 计划LP前单次给药，将提供以下信息 急性动力学。 这项研究还将确定是否存在关系 患者CD 4细胞浓度与CSF司他夫定的疗效之间的关系 条目以及CSF白色细胞之间是否存在关系 浓度或总蛋白和CSF司他夫定的效率 入境