CPCRA 045:EVALUATION OF HIV 1 GENOTYPIC RESISTANCE, VIRAL LOAD & CDS+

这项研究的目的是确定HIV-1耐药性出现的相对比率，并比较参加CPCRA 042/CTN 102的CD+细胞计数为100/mm3的患者血浆HIV RNA水平和CD4+细胞计数的变化。这是NVR方案(CPCRA 042/CTN 102)的多中心耐药亚研究，是奈非那韦(NFV)和利托那韦(RTV)/吲地那韦(IDV)的开放标签随机比较。RTV/IDV是指最初被分配到RTV的一组参与者，其中一些人可能由于对RTV出现严重的不耐受而转而参加IDV。为这项分研究获得的实验室样本将在没有处理任务的情况下进行盲法分析。患者将在12个月的时间内进行登记，并根据主要的NVR研究CPCRA 042/CTN 102确定的共同截止日期跟踪至少12个月。平均随访时间为18个月。样本规模将包括600名患者，其中400名来自CPCRA站点，200名来自CTN站点，将被纳入子研究。所有患者的病毒载量将在基线和随访期间进行测定。最初，在最初分配的RTV组中随机选择50名患者的样本将被确定进行耐药性测试。在这组人中，那些接受RTV/IDV超过1个月的样本将被分析基因耐药，以获得对耐药发展速度的估计，并估计与对RTV/IDV耐药相关的疾病进展的风险。

The purpose of this research is to determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD+ cell counts < 100/mm3 who are enrolled in CPCRA 042/CTN 102. This is a multicenter resistance substudy of the NvR Protocol (CPCRA 042/CTN 102), an open-label, randomized comparison of nelfinavir (NFV) and ritonavir (RTV)/indinavir (IDV). RTV/IDV refers to the group of participants initially assigned to RTV, some of whom may have switched to IDV due to the development of significant intolerance to RTV. Laboratory specimens obtained for this substudy will be analyzed blinded to the treatment assignment. Patients will be enrolled over a 12-month period and followed for a minimum of 12 months to a common closing date, determined by the main NvR study, CPCRA 042/CTN 102. The average follow up is estimated to be 18 months. The sample size will include 600 patients, 400 from CPCRA sites and 200 from CTN sites, will be enrolled in the substudy. Viral loads will be determined on all patients at baseline and during follow up. Initially, specimens for 50 randomly chosen patients in the group originally assigned RTV will be identified for resistance testing. Of this group, specimens for those who have received RTV/IDV for more than 1 month will be analyzed for genotypic resistance to obtain an estimate of the rate o resistance development and to estimate the risk of disease progression associated with resistance to RTV/IDV.