LOPINAVIR/RITONAVIR VS GW433908 & RITONAVIR/LOPINAVIR AND GW433908

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。A5143是一项选择性随机，开放标签，平行和比较的研究，洛匹那韦/利托那韦（LPV/RTV）与GW433908和利托那韦（GW433908 + RTV）与洛匹那韦/利托那韦和GW433908 （LPV/RTV + GW433908）联合富马酸替诺福韦二氧吡酯（TDF）和一种或两种核苷逆转录酶抑制剂（NRTIs）。本研究的主要目的是比较在病毒学治疗失败的HIV感染者中联合使用抗HIV药物的安全性、有效性和耐受性。受试者将根据他们过去服用的药物被随机分配到三个治疗组之一。所有受试者将接受TDF和一到两次nrti。另外，A组患者将接受洛匹那韦和利托那韦，B组患者将接受GW433908和利托那韦，C组患者将接受洛匹那韦、利托那韦和GW433908。研究参与时间为48周，共纳入216名受试者。最多15名受试者将在IU网站注册。将需要九次大约一小时的研究访问。受试者将接受血液测试，以确定CD4细胞和HIV病毒载量。

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. A5143 is a selectively randomized, open-label, parallel and comparative study of lopinavir/ritonavir (LPV/RTV) versus GW433908 and ritonavir (GW433908 + RTV) versus lopinavir/ritonavir and GW433908 (LPV/RTV + GW433908) in combination with tenofovir disoproxil fumarate (TDF) and one or two nucleoside reverse transcriptase inhibitors (NRTIs). The primary objective is to compare the safety, efficacy, and tolerability of a combination of ant-HIV drugs in subjects who are infected with the HIV with virologic treatment failure. Subjects will be randomized to one of three treatment arms based on what medications they have taken in the past. All subjects will receive TDF and one or two NRTIs. In addition, those subjects in Arm A will receive lopinavir and ritonavir, those in Arm B will receive GW433908 and ritonavir, and those in Arm C will receive lopinavir, ritonavir, and GW433908. Study participation will be 48 weeks with a total of 216 subjects enrolled. Up to 15 subjects will be enrolled at the IU site. Nine study visits of approximately one hour's duration will be required. Subjects will undergo blood tests to determine CD4 cells and HIV viral loads.