ATN015 Lab Section 5 Form: Chemistry [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 5 Form: Chemistry [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

本数据集源自实验室第5部分表格：化学检测[CRF 4]

研究概况
本研究为一项前瞻性概念验证研究，纳入在入组前已接受包含蛋白酶抑制剂（PI）的高效抗反转录病毒治疗（HAART）且HIV-1 RNA水平被持续抑制至少6个月的受试者。研究旨在评估将含PI的持续HAART方案转换为短周期治疗（SCT）所产生的影响。研究的主要终点为证实：接受SCT的受试者病毒载量反弹率不高于持续HAART治疗受试者的预期反弹率。尽管病毒载量抑制的维持可被视为安全性或有效性终点，但本试验被界定为安全性评估。本研究由儿科艾滋病临床试验组（PACTG）联合背书，研究对象为当前正接受HAART方案且经证实存在病毒抑制的12至24岁HIV阳性青少年。