ANTIRETROVIRAL THERAPY FOR HIV-INFECTED ADULTS PRESENTING WITH ACUTE

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。 这项研究是在患有急性机会性感染(OIS)或肺炎的HIV-1感染者中进行的，目的是确定在这一人群中开始抗逆转录病毒(ARV)治疗的最佳时机。受试者将在开始急性OI治疗后的头两周内随机接受ARV治疗，或者接受不同于四周到三十二周的ARV治疗。受试者将被跟踪观察48周。大约有282门学科将在全国招生，其中5到10门将在当地招生。主要终点将是生存、病毒学控制和艾滋病进展的综合终点。OI治疗的成功将通过住院时间、并发症发生率、不良事件和治疗期间发生的严重毒性来评估。一项药代动力学亚研究将确定洛比那韦/利托那韦在急性OI/肺炎期间的药代动力学特征。

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 in HIV-1 infected subjects with acute opportunistic infections (OIs) or pneumonia is being conducted to define the optimal timing for initiating antiretroviral (ARV) therapy in this population. Subjects will be randomized to receive ARV within the first two weeks after starting acute OI therapy or have ARV therapy differed between four and thirty-two weeks. Subjects will be followed through 48 weeks. Approximately 282 subjects will enroll nationally with five to ten enrolled locally. The primary endpoint will be a combined endpoint of survival, virologic control, and AIDS progression. Success of OI treatment will be evaluated by duration of hospitalization, complication rates, adverse events, and serious toxicities occurring during treatment. A pharmacokinetic substudy will determine the pharmacokinetic profile of lopinavir/ritonavir during an acute OI/pneumonia phase.