ANTIRETROVIRAL THERAPY FOR HIV-INFECTED ADULTS PRESENTING WITH ACUTE

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究在HIV-1感染的急性机会性感染（OI）或肺炎受试者中进行，旨在确定在该人群中开始抗逆转录病毒（ARV）治疗的最佳时机。 受试者将被随机分配在开始急性OI治疗后的前两周内接受ARV治疗，或在4周和32周之间接受不同的ARV治疗。 受试者将接受48周随访。 约282例受试者将在全国范围内入组，5 - 10例在当地入组。 主要终点将是生存、病毒学控制和艾滋病进展的联合终点。 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价OI治疗的成功。 药代动力学子研究将确定洛匹那韦/利托那韦在急性OI/肺炎期的药代动力学特征。

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.