A5211 STUDY OF THE SAFETY AND EFFICACY OF SHC417690 IN HIV-INFECTED SUBJECTS

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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 A5211是一项前瞻性、开放标签、多中心、为期30周的初步试验（随访持续至54周），受试者为HIV-1感染受试者，接受首个基于蛋白酶抑制剂（PI）的治疗方案（定义为至少2种核苷逆转录酶抑制剂[NRTI]+至少1种PI）后病毒学抑制至少48周。 不允许既往使用非核苷类逆转录酶抑制剂。 入组时，受试者从当前PI转换为利托那韦加强阿扎那韦（ATV/RTV）6周，以监测不良反应（步骤1）。 当前PI包括ATV的受试者合格，将在第1步入组研究。 第3周时血浆HIV-1 RNA 50拷贝/mL的受试者和在6周导入期内发生治疗限制性不良反应的受试者将退出研究并被替换。 否则，受试者在第6周停止NRTI治疗，并在研究步骤2期间继续接受ATV/RTV单药维持治疗方案。 本研究的主要目的是评估受试者接受ATV/RTV单独维持治疗24周后病毒学失败的风险。 病毒学失败定义为连续2次血浆HIV-1 RNA测量？200拷贝/mL。 HIV-1 RNA测量值> 200拷贝/mL的受试者必须在30天内返回以确认病毒学失败，如果第二次病毒载量> 1000拷贝/mL，则将进行实时基因分型。 关于未来抗逆转录病毒治疗的决定将根据当前的临床指南做出，可能包括恢复先前的联合治疗。 将对在第2步永久停止研究治疗的所有受试者（包括因病毒学失败而改变治疗的受试者）进行治疗结束/研究期间随访。

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. A5211 is a prospective, open-label, multicenter, 30-week pilot trial (with follow-up continuing to 54 weeks) in HIV-1-infected subjects with virologic suppression for at least 48 weeks on their first protease inhibitor (PI)-based regimen (defined as at least 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus at least 1 PI). Prior use of nonnucleoside reverse transcriptase inhibitors is not allowed. At entry, subjects switch from their current PI(s) to ritonavir-boosted atazanavir (ATV/RTV) for 6 weeks to monitor for adverse effects (Step 1). Subjects whose current PIs include ATV are eligible and will enter the study at Step 1. Subjects with a plasma HIV-1 RNA 50 copies/mL at week 3 and those who experience treatment-limiting adverse effects during the 6-week lead-in are discontinued from the study and are replaced. Otherwise, subjects discontinue their NRTIs at week 6 and remain on a maintenance regimen of ATV/RTV alone for the duration of the study Step 2. The primary purpose of this study is to evaluate the risk of virologic failure in subjects 24 weeks after treatment with ATV/RTV maintenance therapy alone. Virologic failure is defined as 2 consecutive plasma HIV-1 RNA measurements ?200 copies/mL. Subjects with HIV-1 RNA measurements 200 copies/mL must return within 30 days for confirmation of virologic failure, at which point real-time genotyping will be performed if the second viral load is 1000 copies/mL. Decisions about future antiretroviral therapy will be made according to current clinical guidelines and may include resumption of previous combination therapy. All subjects who permanently discontinue study treatment on Step 2, including those who change therapy due to virologic failure, will be followed off treatment/on study.