THE IMPACT OF VIRAL LOAD SUPPRESSION IN ADOLESCENTS

病毒载量抑制对青少年的影响

• 批准号: 7376322
• 负责人: Sue Ellen Abdalian
• 金额: $ 0.64万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376322
• 关键词: IMPACT; VIRAL; LOAD; SUPPRESSION; ADOLESCENTS

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. This is a multicenter prospective randomized unmasked Phase II study of two groups of subjects who have successfully suppressed their HIV-1 RNA levels for a minimum of 6 months prior to randomization. Randomization will be block-stratified within center. The pre-randomization therapy for both groups will be highly active antiretroviral therapy (HAART) (including a protease inhibitor). The comparison of the two groups will assess the impact of switching from continuation HAART with a PI to short-cycle therapy (SCT). This is a non-inferiority trial with the primary objective of showing that the rate of viral load rebound in the SCT arm does not exceed that in the continuous HAART arm by an amount that would lead to concerns about the safety of SCT. While maintenace of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial is construed as an assessment of safety. Adherence will be studied as a secondary objective as part of clinical and safety monitoring in the protocol; medication adherence measures will be conducted every two weeks.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。这是一项多中心前瞻性随机非公开 II 期研究，研究对象为两组受试者，这些受试者在随机分组前至少 6 个月内成功抑制了 HIV-1 RNA 水平。随机化将在中心内进行分块分层。两组的随机分组前治疗均为高效抗逆转录病毒治疗（HAART）（包括蛋白酶抑制剂）。两组的比较将评估从带有 PI 的持续 HAART 转为短周期治疗 (SCT) 的影响。这是一项非劣效性试验，主要目的是表明 SCT 组的病毒载量反弹率不超过连续 HAART 组，其幅度不会导致对 SCT 安全性的担忧。虽然维持病毒载量抑制可以被视为安全性或有效性终点，但该试验被解释为安全性评估。 依从性将作为次要目标进行研究，作为方案中临床和安全监测的一部分；药物依从性措施将每两周进行一次。