ATN015 HIV Related Diagnosis Form [CRF 2A] Dataset in Short-Cycle Therapy in Adolescents Following Continuous Therapy with Established Viral Suppression: The Impact on Viral Load Suppression

Data from HIV Related Diagnosis Form [CRF 2A]
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

来自HIV相关诊断表格[病例报告表2A（CRF 2A）]的数据

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），且HIV-1 RNA水平已持续抑制至少6个月的受试者。本研究评估了将含PI的持续HAART方案转换为短周期治疗（short-cycle therapy, SCT）的影响。研究的主要目标为证明，接受SCT治疗的受试者的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在接受HAART方案且经证实存在病毒抑制的12至24岁HIV阳性青少年。