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。这是对两组受试者的多中心前瞻性随机未掩盖的II期研究，这些受试者在随机分组之前至少6个月成功抑制了HIV-1 RNA水平。随机化将在中心内进行块分层。两组的随机疗法将是高度活跃的抗逆转录病毒疗法（HAART）（包括蛋白酶抑制剂）。两组的比较将评估从持续HAART使用PI转换为短周期治疗（SCT）的影响。这是一项非效率试验，其主要目的是表明SCT组中病毒载荷的速率在连续的HAART ARM中不会超过导致对SCT安全性的担忧的数量。虽然可以将病毒载荷抑制的维持剂视为安全性或功效终点，但该试验被解释为对安全性的评估。 作为协议中临床和安全监测的一部分，将研究依从性。药物依从性措施将每两周进行一次。