AMD11070 IN HIV-POSITIVE SUBJECTS (A5210)

AMD11070 在 HIV 阳性受试者中的应用 (A5210)

• 批准号: 7380461
• 负责人: Michael S. Saag
• 金额: $ 4.11万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380461
• 关键词: AMD11070; HIV; POSITIVE; SUBJECTS; A5210

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. A5210 is a dose escalating, open-label, safety and activity study of AMD11070. Subjects are admitted to the GCRC for the dosing period. Treatment will continue for 10 consecutive days. Subjects will be allowed daytime passes away from the GCRC on days 4,6,7,8, and 9. Thirty-six-hour pharmacokinetic (PK) profiles (intensive 24-hour PK and a trough level at Hour 30-38) will be obtained at steady state, beginning with the last dose of AMD11070, and will include terminal PK elimination profiles. Trough PK collections will be drawn on day 6 or 7, depending on the treatment group, to assess CXCR4 receptor saturation and characterize drug accumulation. HIV-1 RNA levels will be assessed on Days 0, 1, 2, 5, 7, 10, 14, 17, 30 and 90. Safety labs will bevobtained at Days 0, 5, 10, 17, 30, and 90. Subjects who have not restarted antiretroviral medications will also be assessed for safety and efficacy on Day 21. Primary Objectives: 1. To determine the safety of several dose levels of AMD11070 (with the starting dose determined by the results of A5191) administered over 10 days to HIV-infected subjects who harbor X4-tropic virus. 2. To determine the proportion of subjects per cohort who have a >1 log10 rlu reduction in X4-tropic virus during 10 days of AMD11070 treatment or in the 7 days following treatment discontinuation, and to describe changes from baseline to Day 10 in log10 rlu corresponding to X4-tropic virus.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。列出的机构适用于该中心，这不一定是调查员的机构。 A5210是AMD11070的剂量升级，开放标签，安全性和活动研究。在给药期内，受试者被接受GCRC。治疗将连续10天持续。在第4,6,7,8天和9天，将允许受试者从GCRC中脱离GCRC，而36小时的药代动力学（PK）配置文件（密集的24小时PK和30-38小时下的槽水平）将在稳定状态下获得，从最后一个剂量开始，并将包括AMD11070的最后一个剂量，并将包括AMD11070的最后一个终端PK emimininer pk Eliminitional Pefiles。根据治疗组的不同，将在第6或第7天绘制槽PK收集，以评估CXCR4受体饱和度并表征药物积累。 HIV-1 RNA水平将在第0、1、2、5、7、10、14、17、30和90天进行评估。安全实验室将在第0、5、5、10、17、30和90天进行。根据A5191的结果）在携带X4-循环病毒的HIV感染受试者的10天内给药。 2。确定在AMD11070治疗的10天或在治疗中停用后的7天内，X4冰期病毒降低> 1 log10 rlu的受试者的比例，并描述从基线到第10天到第10天的变化，从log10 rlu通用X4-Tropic-Tropic病毒。