A PHASE IIIB, OPEN-LABEL, RANDOMIZED, MULTI-CENTER STUDY COMPARING THE ANTIVI

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项多中心、开放标签的双治疗臂研究，旨在展示基于阿扎那韦/利托那韦(ATV/RTV)的方案与基于洛匹那韦/利托那韦(LPV/RTV)的方案在人类免疫缺陷病毒(HIV)患者中的抗病毒疗效、安全性、耐受性和对血脂的影响，这些患者最初在基于非核苷类逆转录酶抑制剂(NNRTI)的抗逆转录病毒治疗中表现出病毒学失败。这项研究的目标是在全国范围内招收200名参与者，并在当地招收10门学科。研究程序将包括心血管风险和生活方式评估、病史、体检、CD4计数以及血液和尿液测试。在两年的时间里，大约需要11次考察访问。

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 is a multi-center, open label two treatment arm study to demonstrate the antiviral efficacy, safety, tolerability, and effect on serum lipids of an atazanavir/ritonavir (ATV/RTV) based regimen versus lopinavir/ritonavir (LPV/RTV) based regimen in subjects with Human Immunodeficiency Virus (HIV) who have exhibited initial virologic failure on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy. The study will target enrollment of 200 participants nationally with ten subjects to enroll locally. Study procedures will include cardiovascular risk and lifestyle assessments, medical histories, physical exams, CD4 counts, and blood and urine tests. About 11 study visits will be required over a two-year period.