ATN015 Lab Section 1 Form [CRF 4] Dataset in Short-Cycle Therapy in Adolescents Following Continuous Therapy with Established Viral Suppression: The Impact on Viral Load Suppression

Data from Lab Section 1 Form [CRF 4]
Study Description
A prospective proof of concept study of subjects who had successfully suppressed their HIV-1 RNA levels for a minimum of 6 months prior to study entry on highly active antiretroviral therapy (HAART) including a protease inhibitor (PI). The study assessed the impact of switching from continuous HAART with a PI to short-cycle therapy (SCT). The primary objective was to show that the rate of viral load rebound on SCT does not exceed that which would be expected in subjects on continuous therapy. While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial was construed as an assessment of safety. The study was co-endorsed by the Pediatric AIDS Clinical Trials Group (PACTG). HIV-positive youth 12 to 24 years of age currently on a HAART regimen with documented viral suppression

实验室第1部分表格[CRF 4]所获数据

研究概况
本研究为一项前瞻性概念验证研究，纳入入组前已接受含蛋白酶抑制剂(protease inhibitor, PI)的高效抗反转录病毒治疗(highly active antiretroviral therapy, HAART)至少6个月、且HIV-1 RNA水平已成功得到抑制的受试者。本研究旨在评估将受试者的治疗方案从持续使用含PI的HAART转换为短周期治疗(short-cycle therapy, SCT)所产生的影响。
本研究的主要终点为证明：接受SCT的受试者的病毒载量反弹率不会高于持续HAART治疗受试者的预期反弹率。尽管病毒载量抑制状态的维持可被视为安全性或有效性终点，但本试验的定位为一项安全性评估。本研究由儿童艾滋病临床试验组(Pediatric AIDS Clinical Trials Group, PACTG)联合支持。本研究的受试者为当前正接受HAART方案治疗、且经证实存在病毒载量抑制的12至24岁HIV阳性青少年。