THE IMPACT OF VIRAL LOAD SUPPRESSION IN ADOLESCENTS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项多中心前瞻性随机II期研究，两组受试者在随机化前成功抑制HIV-1 RNA水平至少6个月。随机化将在中心内进行分组分层。两组的预随机化治疗均为高效抗逆转录病毒治疗（HAART）（包括一种蛋白酶抑制剂）。两组的比较将评估从持续HAART与PI转换到短周期治疗（SCT）的影响。这是一项非劣效性试验，其主要目的是显示SCT组的病毒载量反弹率不会超过持续HAART组的病毒载量反弹率，这将导致对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；药物依从性测量将每两周进行一次。

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.