MULTIPLE DOSE STUDY OF LIPOSOMAL AMIKACIN IN HIV SEROPOTISTIVE PATIENTS

脂质体阿米卡星在 HIV 血清阳性患者中的多剂量研究

• 批准号: 6276296
• 负责人: TERRENCE F BLASHKE
• 金额: $ 4.03万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276296
• 关键词: HIV infections; Mycobacterium avium; aminoglycoside antibiotics; antiviral agents; clinical research; clinical trial phase I; cytotoxicity; dosage; drug administration rate /duration; drug screening /evaluation; human immunodeficiency virus; human subject; human therapy evaluation; injection /infusion; liposomes; microorganism disease chemotherapy; pharmacokinetics; renal toxin; volunteer

The goal of this protocol is to define the safety and pharmacokinetics of Mikasome, a liposomal formulation of the aminoglycoside antibiotic amikacin, when given in multiple dose regime. The study is being carried out in HIV-positive volunteers, since this is one of the target populations for the use of this investigational agent which may be efficacious in the treatment of Mycobacterium Avium Complex (MAC). Non- clinical and early human data suggest that the liposomal formulation of amikacin may have substantially different pharmacokinetics, and therefore possible differences in efficacy and toxicity, compared with other formulations. The study design is a parallel group dose escalation study, with each subject receiving a daily infusion of liposomal amikacin for seven consecutive days. Intensive pharmacokinetic sampling is carried out on the first and last infusion days, and for several weeks afterwards. Subjects are monitored closely for signs and symptoms of toxicity, expecially renal toxicity. Pharmacokinetic parameters are analyzed by standard compartmental and non-compartmental methods.

该方案的目标是定义安全性和药代动力学。 米卡索姆，氨基糖苷类抗生素的脂质体制剂 阿米卡星，当以多剂量给药时。这项研究正在进行中 在艾滋病毒阳性志愿者中进行，因为这是目标之一 使用这种研究试剂的人群，可能是 治疗禽型分枝杆菌复合体(MAC)疗效显著。非- 临床和早期人类数据表明，脂质体制剂 阿米卡星可能有很大不同的药代动力学，并且 因此，在疗效和毒性方面可能存在差异， 其他配方。研究设计为平行分组剂量 上报研究，每个受试者每天接受一次 阿米卡星脂质体，连续7天。集约化 在第一次和最后一次输液时进行药代动力学采样 几天，以及之后的几个星期。受试者受到严密监视 治疗毒性的症状和体征，尤其是肾毒性。 药代动力学参数分析采用标准房室和 非分隔法。