PACTG P1021: EMTRICITABINE IN COMBINATION WITH EFAVIRENZ & DIDANOSINE

PACTG P1021：恩曲他滨与依非韦伦联用

• 批准号: 7374341
• 负责人: Elizabeth Jane McFarland
• 金额: $ 3.13万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-24 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374341
• 关键词: RNA; aging; efavirenz

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. PACTG P1021 is a Phase I/II open label study which will evaluate the long-term safety and antiviral activity of a once-daily triple combination regimen (FTC, EFV, and ddI) in HIV-1 infected pediatric subjects (90 days to 21 years of age) who are nanve to antiretroviral therapy (<56 days perinatal prophylaxis, <7 days of cumulative antiretroviral treatment) and have screening plasma HIV-1 RNA levels >5000copies/mL. The study will enroll 36 to 42 evaluable HIV-1 infected pediatric subjects who will receive treatment for a minimum of 48 wks. Subjects will be stratified based on their age at entry; at least 6 subjects will be enrolled per age group (90 days to <3 years of age; 3 to 12 years of age; and 13 to 21 years of age) to allow adequate pharmacokinetic data to be collected in each age group. PACTG P1021 will characterize the disposition of FTC, will determine the PK data for ddI-EC QD, and compare the bioavailability of the enteric coated formulation with the ddI pediatric powder for oral solution. Intensive PK studies at Week 2 of treatment will be used to determine if dose adjustments of the initial doses of one, two, or all three study medications are needed. Dose adjustments will be implemented at the subject's next study visit. P1021 will evaluate the association between virologic and immunologic responses and PK levels, adherence measures, genotypes of cytochrome P4503A drug metabolizing enzymes, recent thymic emigrants, and HIV RNA determinants. Detailed studies of immunologic function changes during therapy will be performed. The HIV resistance mutation profile of each subject will be correlated with virologic, pharmacologic and immunologic response markers in order to evaluate the role of resistance in virologic failure.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。 PACTG P1021是一项I/II期开放标签研究，它将评估HIV-1感染的小儿受试者（90天至21）中每天每天三重组合方案（FTC，EFV和DDI）的长期安全性和抗病毒活性年龄）患有抗逆转录病毒疗法（<56天的围产期预防，<7天的累积抗逆转录病毒治疗），并具有筛查血浆HIV-1 RNA水平> 5000 copies/ml。该研究将招募36至42个可评估的HIV-1感染儿科受试者，他们将接受至少48周的治疗。受试者将根据入境年龄进行分层；每个年龄组将至少有6个受试者（90天至3岁； 3至12岁；和13至21岁的年龄），以允许在每个年龄段收集足够的药代动力学数据。 PACTG P1021将表征FTC的处置，将确定DDI-EC QD的PK数据，并将肠涂层配方的生物利用度与DDI儿科粉末的生物利用度进行口服溶液。在治疗第2周的强化PK研究将用于确定是否需要一，二或所有三种研究药物的初始剂量的剂量调整。下一次研究访问将在该学科的下一次学习访问中实施剂量调整。 P1021将评估病毒学和免疫学反应与PK水平，依从性测量，细胞色素P4503A药物代谢酶的基因型，最近的胸腺移民和HIV RNA决定征的关联。将在治疗过程中进行免疫功能变化的详细研究。每个受试者的HIV耐药性突变谱将与病毒学，药理和免疫反应标记相关，以评估耐药性在病毒衰竭中的作用。