PHARMACOLOGY AGENDA

药理学议程

• 批准号: 5205123
• 负责人: MICHAEL M LEDERMAN
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5205123
• 关键词: AIDS; AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; comorbidity; cooperative study; drug interactions; drug metabolism; drug screening /evaluation; female; gender difference; human pregnant subject; human subject; human therapy evaluation; intracellular; pharmacokinetics; pharmacology; racial /ethnic difference

A pediatric component the Case Western Reserve University ACTU is proposed. The component will append to a highly successful adult ACTU (1st or 2nd quartile), which will provide the infrastructure to enable efficient enrollment of children at low additional cost. Though no funding has been available for pediatric protocols in the past, three patients have been successfully entered and maintained on pediatric trials. The rapidly expanding population of HIV-infected children in Cleveland ensures future candidates for enrollment. Subjects will be drawn from patients referred by community pediatricians and obstetricians to the Special Immunology Unit, the multi-disciplinary AIDS specialty clinic at University Hospitals of Cleveland. In addition, referrals will be made from two large HIV screening programs for urban minority pregnant women; both of these screening programs are administered by the pediatric component director, insuring expeditious referral. The total predicated referrals from these programs will equal 6 children with confirmed infection, and 25-48 seropositive maternal-infant pairs over the first twelve months, enabling enrollment of a minimum of six patients the first year, and 12/yr by the end of the funding period.

一个儿科组成部分，凯斯西储大学ACTU的建议。 该组件将附加到一个非常成功的成人ACTU（第一或第二 四分位数），这将提供基础设施， 以较低的额外费用招收儿童。 虽然没有资金 在过去的儿科协议中，有三名患者 成功进入并维持儿科试验。 迅速 克利夫兰艾滋病毒感染儿童人数的增加确保了未来 报名的候选人。 受试者将从转诊患者中抽取 由社区儿科医生和产科医生向特殊免疫学 大学医院多学科艾滋病专科诊所 克利夫兰。 此外，将从两个大型艾滋病毒感染者 为城市少数民族孕妇提供筛查计划;这两项 筛查项目由儿科主任管理， 确保快速转诊。 来自这些的断言引用总数 方案将相当于6名儿童确诊感染， 在头12个月内血清反应阳性的母婴对， 第一年至少入组6例患者， 融资期结束。