PACTG 1021:

PACTG 1021：

• 批准号: 7380710
• 负责人: SANDRA K BURCHETT
• 金额: $ 0.74万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380710
• 关键词: PACTG; 1021

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. The use of different anitretrovial agents in combination drug therapy regimens is the current state of the art for mangement of HIV-infected subjects. These regimens combine different antiviral targets, which are expected to increase the efficacy, decrease the toxicity and delay the development of resistance of the individual drugs. The anticipated synergistic effect produced by drug combination therapy is one of the primary objectives for evaluation in this study. The once daily pediatric dose regimen of FTC that will be used in PACTG P1021 is supported by data from a Phase I single-dose trial in HIV-infected or exposed pediatric subjects less than 18 years of age. The selection of a once daily dosing approach was based on the recently published data for the ANRS clinical trial in France, which was previously discussed (2,4,5,6). The difficulty in assuring adherence with current regimens requiring multiple daily doses is well recognized as a major barrier to effective antiretroviral therapy. A once daily regimen offers both advantage for pediatric subjects and their caregivers.

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。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。在联合药物治疗方案中使用不同的抗逆转录病毒药物是HIV感染受试者管理的当前技术水平。这些方案结合了联合收割机不同的抗病毒靶点，有望提高疗效，降低毒性，延缓个体药物耐药性的发展。药物联合治疗产生的预期协同效应是本研究评价的主要目的之一。 PACTG P1021中将使用的FTC儿科每日一次给药方案得到了在18岁以下HIV感染或暴露儿科受试者中进行的I期单次给药试验数据的支持。选择每日一次给药方法是基于最近发表的法国ANRS临床试验数据，之前对此进行了讨论（2、4、5、6）。目前的治疗方案需要每日多次给药，很难确保患者坚持治疗，这是有效抗逆转录病毒治疗的主要障碍。每日一次给药方案为儿科受试者及其护理人员提供了优势。