ATN015 Lab Toxicity and Follow Up Form: Fasting [CRF 14] Dataset in Short-Cycle Therapy in Adolescents Following Continuous Therapy with Established Viral Suppression: The Impact on Viral Load Suppression

Dataset with no observations
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

不含观测样本的数据集

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水平已成功被抑制的受试者。本研究评估了将治疗方案从持续使用含PI的HAART切换至短周期治疗（short-cycle therapy, SCT）所产生的影响。研究的主要目标为证实：接受SCT治疗的受试者的病毒载量反弹速率，不会超过持续HAART治疗受试者的预期反弹速率。尽管维持病毒载量抑制状态既可被视为安全性终点，也可作为有效性终点，但本试验被定义为一项安全性评估研究。本研究由儿童艾滋病临床试验组（Pediatric AIDS Clinical Trials Group, PACTG）联合支持。本研究的受试人群为12至24岁的HIV阳性青少年，当前正接受HAART治疗且经证实病毒载量已受抑制。