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

这是一项双盲、安慰剂对照研究， 耐受性和抗逆转录病毒活性的研究 开放标签齐多夫定（ZVD）和拉米夫定（3 TC）治疗HIV感染者 患者本研究的目的是：评价安全性， 耐受性和有效性（抗逆转录病毒活性）， 与ZDV和3 TC联合治疗无症状或轻度症状的HIV- 感染患者;评估多剂量的 在该患者人群中， ZDV、3 TC和ZDV-266之间的药代动力学相互作用;以及 表征对顺铂-266产生耐药性的时间过程， 通过基因分型和体外药敏试验进行表征 对HIV 266耐药的HIV病毒株。

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.