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

CPRA 045：HIV 1 基因型耐药性、病毒载量的评估

• 批准号: 6265778
• 负责人: CHERYL L BESCH
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-19 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265778
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; clinical trial phase I; genotype; human immunodeficiency virus 1; human subject; human therapy evaluation; indinavir; protease inhibitor; ritonavir; virus RNA

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.

本研究的目的是确定 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 < 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 NvR 方案 (CPCRA 042/CTN 102) 的多中心耐药子研究，NvR 方案 (CPCRA 042/CTN 102) 是一项开放标签、 奈非那韦 (NFV) 和利托那韦 (RTV)/茚地那韦 (IDV) 的随机比较。 RTV/IDV 是指最初分配到 RTV 的参与者群体，其中一些人可能由于对 RTV 产生严重不耐受而转而使用 IDV。 本次亚研究获得的实验室标本将在不了解治疗分配的情况下进行分析。 患者将在 12 个月的时间内入组，并随访至少 12 个月，直至共同截止日期，该截止日期由主要 NvR 研究 CPCRA 042/CTN 102 确定。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 名患者来自 CPCRA 站点，200 名患者来自 CTN 站点，将参加该子研究。 将在基线和随访期间确定所有患者的病毒载量。 最初，将确定最初分配 RTV 的组中随机选择的 50 名患者的样本进行耐药性测试。 在该组中，将对接受 RTV/IDV 超过 1 个月的患者的样本进行基因型耐药性分析，以获得耐药性发展速率的估计值，并估计与 RTV/IDV 耐药性相关的疾病进展风险。