CLINICAL TRIAL: A PHASE IV, RANDOMIZED, OPEN-LABEL STUDY OF THE TOLERABILITY OF

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。 假设 每日一次的洛匹那韦/利托那韦(LPV/r)口服液的耐受性比每天一次的LPV/r胶囊更好。 主要目标 比较每日1次LPV/r(800/200 mg)10毫升液体与6粒胶囊的耐受性 次要目标 在第4周或停止治疗时，对交叉试验的两个4周步骤(步骤1和2)中的每一个步骤进行比较。 1.1腹泻的最严重程度 1.2恶心的最严重程度 1.3抗运动或止吐治疗的使用 1.4出现恶心和腹泻以外的不良反应(不良反应) 1.5出现实验室异常，如血脂、转氨酶 1.6限制治疗毒性的研究进展 1.7血浆HIV-1 RNA抑制率为50拷贝/毫升 1.8症状苦恼程度 2比较LPV/r每日一次口服液与LPV/r胶囊在第1、2周的药代动力学 3确定在步骤3开始时选择每种治疗方案的受试者的比例 4在步骤3开始时选择每日一次LPV/r以外的其他选项的人对液体或胶囊的声明偏好，以及对每种液体或胶囊的喜欢或不喜欢的程度 5确定在纳入研究时液体LPV/r品尝测试后选择不随机选择的筛查个体的比例 6第三步结束时血浆HIV-1RNA的测定率为50拷贝/毫升

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. Hypothesis Once daily lopinavir/ritonavir (LPV/r) liquid will be better tolerated than once daily LPV/r capsules. Primary Objectives To compare the tolerability of once daily LPV/r (800/200 mg) as 10 ml liquid vs. 6 capsules Secondary Objectives 1 To compare at week 4, or at the time therapy is discontinued, for each of the two 4 week Steps of the cross-over trial (Steps 1 and 2). 1.1 Maximum severity of diarrhea 1.2 Maximum severity of nausea 1.3 Use of antimotility or antiemetic therapy 1.4 Development of adverse events (AEs) other than nausea and diarrhea 1.5 Development of laboratory abnormalities, e.g. lipids, transaminases 1.6 Development of treatment-limiting toxicity 1.7 Plasma HIV-1 RNA suppression to 50 copies/mL 1.8 Level of symptoms distress 2 To compare the pharmacokinetics of once daily liquid and capsules of LPV/r at week 2 of Steps 1 and 2 3 To determine the proportion of subjects who choose each of the therapeutic options at start of Step 3 4 The stated preference for liquid or capsules, and the degree of like or dislike of each in those who choose an option other than once daily LPV/r at start of Step 3 5 To determine the proportion of screened individuals who choose not to be randomized after the liquid LPV/r taste test at the time of enrollment into the study 6 The determine rates of plasma HIV-1 RNA 50 copies/mL at the end of Step 3