LOPINAVIR/RITONAVIR VS GW433908 & RITONAVIR/LOPINAVIR AND GW433908

点击翻译按钮获取中文摘要

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.