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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 假设 每日一次洛匹那韦/利托那韦（LPV/r）液体的耐受性优于每日一次LPV/r胶囊。 主要目标 比较每日一次LPV/r（800/200 mg）10 ml液体与6粒胶囊的耐受性 次要目的 1 在交叉试验的两个4周步骤（步骤1和2）中的每一个步骤的第4周或治疗中止时进行比较。 1.1 腹泻最严重程度 1.2 恶心的最大严重程度 1.3 使用抗蠕动剂或止吐剂治疗 1.4 发生恶心和腹泻以外的不良事件（AE） 1.5 实验室检查异常，例如脂质、转氨酶 1.6 治疗限制性毒性的发展 1.7 血浆HIV-1 RNA抑制至50拷贝/mL 1.8 症状痛苦程度 2 比较LPV/r每日一次液体和胶囊在步骤1和2第2周的药代动力学 3 确定步骤3开始时选择每种治疗方案的受试者比例 4 在第3步开始时，选择除每日一次LPV/r以外的其他选项的受试者对液体或胶囊的声明偏好，以及对每种药物的喜欢或不喜欢程度 5 确定入组研究时液体LPV/r味觉试验后选择不接受随机化的筛选个体比例 6 步骤3结束时血浆HIV-1 RNA 50拷贝/mL的测定率

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