ATN015 Review of Symptoms Form [CRF 7] Dataset in Short-Cycle Therapy in Adolescents Following Continuous Therapy with Established Viral Suppression: The Impact on Viral Load Suppression

Data from Review of Symptoms Form [CRF 7]
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

症状评估表[CRF 7]相关数据
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（PI）的高效抗反转录病毒治疗（HAART）且HIV-1 RNA水平被成功抑制至少6个月的受试者。本研究评估了将含PI的持续HAART方案切换至短周期治疗（SCT）的影响。本研究的主要目标为证实：接受SCT的受试者病毒载量反弹率不会高于持续HAART方案受试者的预期反弹水平。尽管病毒载量抑制的维持可被视为安全性或有效性终点，但本试验被归类为安全性评估研究。本研究由儿童艾滋病临床试验组（Pediatric AIDS Clinical Trials Group, PACTG）联合认可。本研究的受试人群为当前正接受HAART方案且经实验室证实病毒载量受抑制的12至24岁HIV阳性青少年。