SAFETY TOLERABILITY & ANTIRETROVIRAL ACTIVITY OF DMP-266 WITH ZDV AND 3TC IN HIV

安全耐受性

• 批准号: 6283068
• 负责人: M E EYSTER
• 金额: $ 2.16万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 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/6283068
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; drug screening /evaluation; human subject; lamivudine; reverse transcriptase inhibitors; zidovudine

This is a double blind, placebo-controlled study to assess the safety, tolerability, and antiretroviral activity of DMP-266 in combination with open-label zidovudine (ZVD) and lamivudine (3TC) in HIV infected patients. The objectives of the study are : to evaluate the safety , tolerability and effectiveness (antiretroviral activity) of DMP-266 in combination with ZDV and 3TC in asymptomatic or mildly symptomatic HIV- infected patients; to assess the pharmacokinetics of multiple doses of DMP 266 in this patient population and to assess whether there is a pharmacokinetic interaction betweenZDV, 3TC and DMP-266; and to characterize the time course of development of resistance to DMP-266 and to characterize by genotyping and in vitro susceptibility testing strains of HIV resistant to DMP 266.

这是一项双盲、安慰剂对照研究，旨在评估安全性， DMP-266联合DMP-266的耐受性和抗逆转录病毒活性 开放标记齐多夫定(ZVD)和拉米夫定(3TC)治疗HIV感染 病人。这项研究的目的是：为了评估安全性， DMP-266的耐受性和有效性(抗逆转录病毒活性) 联合ZDV和3TC治疗无症状或轻度症状的HIV- 感染患者；评估多剂量的药代动力学 DMP 266，并评估是否有 ZDV、3TC与DMP-266的药代动力学相互作用 表征对DMP-266和DMP-266的耐药性发展的时间进程 通过基因分型和体外药敏试验来表征 对DMP 266耐药的HIV毒株。