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

本研究的目的是确定HIV-1耐药性出现的相对率，并比较CPCRA 042/CTN 102中CD+细胞计数< 100/mm3的患者样本中血浆HIV RNA水平和CD4+细胞计数的变化。这是一项NvR方案的多中心耐药亚研究（CPCRA 042/CTN 102），一项开放标签，随机比较奈非那韦（NFV）和利托那韦(RTV)/茚地那韦（IDV）。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的严重不耐受而转向IDV。本亚研究获得的实验室标本将对治疗分配进行盲法分析。患者将入组12个月，随访至少12个月，直至主要NvR研究CPCRA 042/CTN 102确定的共同截止日期。平均随访时间估计为18个月。样本量将包括600名患者，其中400名来自CPCRA站点，200名来自CTN站点，将纳入该子研究。将在基线和随访期间确定所有患者的病毒载量。最初，将从最初指定RTV的组中随机选择50名患者的标本进行耐药性检测。在这一组中，将对感染RTV/IDV超过1个月的患者的标本进行基因型耐药性分析，以获得耐药性发展速度的估计，并估计与RTV/IDV耐药性相关的疾病进展风险。

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.