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.

Stavudine是获得许可的有效HIV-1逆转录酶抑制剂 1994。没有系统评估脑脊液stavudine 已经报道了单剂量或以下的浓度 稳态条件。提高了对Stavudine渗透的理解 进入CSF很重要，因为有足够的抑制作用 中枢神经系统中的浓度抑制HIV复制 希望预防或减慢艾滋病痴呆的发展 复杂的。 该协议将检查Stavudine（D4T）在 接受选修的受试者的脑脊液（CSF） 腰穿点（LP）。 将研究两组受试者：1） 那些开处方的Stavudine供临床注意事项，谁将提供 深入了解在稳态条件下达到的CSF浓度； 2）那些未在临床上接受Stavudine的人，但同意接受 单剂量在预定的LP之前，他将提供有关 急性动力学。 这项研究还将确定是否存在关系 CSF Stavudine的患者CD4细胞浓度与效率之间 进入以及是否存在CSF白细胞之间的关系 浓度或总蛋白质以及CSF Stavudine的效率 入口。