CLINICAL TRIAL: HIV TREATMENT-EXPERIENCED PATIENTS TO EVALUATE PA103001-04

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究是一项第二阶段的随机、安慰剂对照、双盲、多次剂量、剂量递增的艾滋病毒治疗研究，患者经历了失败的抗逆转录病毒方案，对至少一种抗艾滋病毒药物类别存在关键耐药突变。当PA103001-04(Bevirimat)加入失败的抗逆转录病毒疗法后，将在多次口服剂量后对最多五种不同剂量水平的PA103001-04(Bevirimat)的抗病毒活性、安全性和药代动力学进行比较。最初，总共48名患者将被随机分为前三个剂量水平进行评估。如果剂量增加到超过最初的三个剂量水平，另外32名患者可能会被随机分配。

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. This study is a Phase II, randomized, placebo-controlled, double blind, multiple dose, dose-escalation study in HIV treatment experienced patients on a failing antiretroviral regimen, harboring key resistance mutations to at least one member of the anti-HIV medicaition classes. The antiviral activity, safety, and pharmacokinetics of up to five different dose levels of PA103001-04 (Bevirimat) will be compared following multiple oral doses when added to a failing antiretroviral regimen. Initially, a total of 48 patients will be randomized to evaluate the first three dose levels. If the doses are escalated beyond the initial three dose levels, an additional 32 patients may be randomized.