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

ACTG 366：患有快速进展的晚期疾病的患者：“RAD-1”

• 批准号: 6308596
• 负责人: ANN PETRU
• 金额: $ 1.75万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6308596
• 关键词: AIDS /HIV neuropathy; AIDS therapy; adolescence (12-20); age difference; child (0-11); clinical research; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; pediatric AIDS; pharmacokinetics; virus load

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.

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。 目的是评价病毒载量和缓解持续时间的下降;按年龄划分的安全性和耐受性;按年龄划分的常规和稳态药代动力学，包括CNS疾病评价以及病毒和药物渗透到CSF中。 该研究包括对以下每一项的至少3次评估：MRI、神经心理学/神经发育（NP/ND）评估、脊髓穿刺，所有这些都在<2 year-old patients. Inclusion criteria are 6 mos-20 years old with >8周的先前治疗中、生长衰竭、CD 4 &lt;15%、CD4%或CD 4数量下降&gt;50%、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个新代理。