ACTG 366: PATIENTS W/ RAPIDLY PROGRESSING ADVANCED DISEASE: "RAD-1"

这项研究为患有晚期疾病的儿童提供了先进的药物组合，药物的选择将取决于他们以前的药物经验。目的是评估病毒载量的下降和反应的持续时间；年龄的安全性和容忍度；按年龄划分的常规和稳态药动学，包括中枢神经系统疾病评估和病毒和药物对脑脊液的渗透。本研究包括以下每项至少3项评估：MRI，神经心理学/神经发育（NP/ND）评估，脊髓穿刺，所有患者均小于2岁。纳入标准为6 ~ 20岁，既往治疗8周，生长衰竭，CD4 <15%, > CD4下降50%或CD4数量下降4%，病毒载量超过100,000或NP/ND疾病进展。儿童必须能够接受至少2种新的药物。

This study offers advanced combinations of drugs to children with advanced disease, and the choices of agents will depend upon their prior drug experiences. Objectives are to evaluate decreses in viral load and durations of response; safety and tolerance by age; routine and steady state pharmacokinetcs by age, including CNS disease evaluation and virus and drug penetration into the CSF. This study includes at least 3 evaluations of each of the following: MRI, neuropsychological/neurodevelopmental (NP/ND) assessments, spinal taps, all in <2 year-old patients. Inclusion criteria are 6 mos-20 years old with >8 weeks of prior therapy, growth failure, CD4 <15%, >50% drop in CD4% or CD4 number, viral load over 100,000 or NP/ND progression of disease. Children must be able to receive at least 2 new agents.