SOUTHEAST PEDIATRIC AIDS CLINICAL TRIALS UNIT

东南儿科艾滋病临床试验中心

• 批准号: 2667781
• 负责人: Robert Floyd Pass
• 金额: $ 105.26万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2667781
• 关键词: 2'3' dideoxycytidine; 2'3' dideoxyinosine; AIDS /HIV test; AIDS education /prevention; AIDS therapy; AIDS vaccines; Mycobacterium avium; Pneumocystis carinii; Pneumocystis pneumonia; Streptococcus pneumoniae vaccine; adolescence (12-20); antiAIDS agent; antiviral agents; antiviral antibody; atovaquone; behavioral /social science research tag; chemoprevention; child (0-11); clinical research; clinical trial phase I; combination chemotherapy; community; cooperative study; cytomegalovirus; dapsone; data management; disease /disorder etiology; drug administration routes; epidemiology; family; ganciclovir; gene therapy; health behavior; human immunodeficiency virus 1; human pregnant subject; human subject; human therapy evaluation; immunotherapy; measles vaccine; microorganism disease chemotherapy; monoclonal antibody; neuropsychological tests; nevirapine; opportunistic infections; outcomes research; passive immunization; pathologic process; pediatric AIDS; pharmacokinetics; phenotype; polymerase chain reaction; premature infant human; protease inhibitor; retinitis; stavudine; tissue /cell culture; vertical transmission; virus DNA; virus RNA; virus infection mechanism; zidovudine

This is a new application for a Pediatric AIDS Clinical Trials Unit (PACTU) that will involve collaboration between the University of Alabama at Birmingham, Emory University in Atlanta and the Medical College of Georgia in Augusta. Investigators with active programs of research and clinical care for infants, children, adolescents and pregnant women with HIV infection will collaborate to form the Southeast PACTU. The Southeast PACTU will bring established programs of research on perinatal infections, antivirals and HIV pathogenesis to the PACTG. The Southeast PACTU will focus on linkage of state-of-the-art laboratory approaches for study of pathogenesis to clinical trials aimed at prevention of perinatal transmission and interruption of primary infection. The Southeast PACTU can contribute the following to the PACTG: (1) Experience translating advances in basic research into tools that can be used to investigate pathogenesis of HIV infection. (2) A record of international leadership in antiviral clinical trials, including phase I antiviral trials in newborns. (3) A distinguished record of achievement in clinical and laboratory studies of congenital and perinatal viral infection. (4) Prior experience with PACTG clinical trials. (5) Leadership in a national collaborative study of HIV natural history in adolescents. (6) Basic and clinical research in major opportunistic pathogens (CMV, HSV, varicella, S. pneumoniae, T. gondii). (7) A new source of clinical trial participants from a region that is under-represented in the PACTG, through established programs that currently reach the majority of women and children with HIV infection in Alabama and Georgia.

这是儿科艾滋病临床试验单位的新申请 (PACTU) 将涉及阿拉巴马大学之间的合作 伯明翰大学、亚特兰大埃默里大学和医学院 乔治亚州奥古斯塔。具有积极研究计划的研究人员 婴儿、儿童、青少年和孕妇的临床护理 HIV 感染者将合作组建东南部 PACTU。东南部 PACTU 将带来围产期研究的既定项目 PACTG 的感染、抗病毒药物和 HIV 发病机制。东南部 PACTU 将重点关注最先进的实验室方法之间的联系 发病机制研究到旨在预防围产期疾病的临床试验 传播和阻断原发感染。 东南部 PACTU 可以向 PACTG 做出以下贡献： (1) 将基础研究进展转化为可应用的工具的经验 用于研究HIV感染的发病机制。 (2) 抗病毒临床试验的国际领先记录， 包括针对新生儿的第一阶段抗病毒试验。 (3) 在临床和实验室方面取得的杰出成就 先天性和围产期病毒感染的研究。 (4)有PACTG临床试验经验。 (5) 在艾滋病自然史国家合作研究中发挥领导作用 在青少年中。 （6）主要机会致病菌（CMV、 HSV、水痘、肺炎链球菌、弓形虫）。 （7）来自某个地区的新的临床试验参与者来源 通过既定计划，在 PACTG 中代表性不足 目前已覆盖大多数感染艾滋病毒的妇女和儿童 阿拉巴马州和佐治亚州。