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

本研究的目的是确定HIV-1耐药性出现的相对比率，并比较CPCRA 042/CTN 102中CD+细胞计数< 100/mm 3的患者样本中血浆HIV RNA水平和CD 4+细胞计数的变化。 这是NvR方案（CPCRA 042/CTN 102）的一项多中心耐药性子研究，是一项奈非那韦（NFV）和利托那韦（RTV）/茚地那韦（IDV）的开放标签、随机比较。 RTV/IDV是指最初分配至RTV的受试者群体，其中一些受试者可能由于对RTV的严重不耐受而转为IDV。 将对该子研究获得的实验室标本进行盲态分析，以确定治疗分配。 患者将在12个月内入组，并随访至少12个月，直至主要NvR研究CPCRA 042/CTN 102确定的共同结束日期。 平均随访时间为18个月。样本量将包括600例患者，400例来自CPCRA研究中心，200例来自CTN研究中心，将入组子研究。 将在基线和随访期间测定所有患者的病毒载量。 最初，将确定最初分配RTV组中随机选择的50例患者的标本进行耐药性试验。 在该组中，将对接受RTV/IDV治疗超过1个月的患者的标本进行基因型耐药分析，以估计耐药发生率，并估计与RTV/IDV耐药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.