WASHINGTON D.C. CONSORTIUM PEDIATRIC AIDS CLINICAL TRIAL

华盛顿特区儿童艾滋病临床试验联盟

• 批准号: 6585713
• 负责人: Hans M Spiegel
• 金额: $ 28.41万
• 依托单位: CHILDREN'S NATIONAL MEDICAL CENTER
• 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 2003-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6585713
• 关键词: 2'3' dideoxycytidine; 2'3' dideoxyinosine; AIDS; AIDS /HIV test; AIDS education /prevention; AIDS vaccines; Epstein Barr virus; Mycobacterium avium; Pneumocystis carinii; Pneumocystis pneumonia; Streptococcus pneumoniae vaccine; adolescence (12-20); antiviral agents; antiviral antibody; atovaquone; behavioral /social science research tag; chemoprevention; child (0-11); clinical research; clinical trial phase I; combination chemotherapy; community; congenital infection; cooperative study; cytomegalovirus; dapsone; data management; drug administration routes; epidemiology; family; ganciclovir; health behavior; human immunodeficiency virus 1; human pregnant subject; human subject; immunotherapy; measles vaccine; microorganism disease chemotherapy; monoclonal antibody; nervous system infection; 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; virus related neoplasm /cancer; zidovudine

The Washington DC Regional Pediatric AIDS Clinical Research Unit (PACTU) will function as a member of the Pediatric AIDS Treatment Group (PACTG) with the Coordinating and Operations Center (CORC) --Spector. The Goals and Specific Aims of the PACTU are the same as those identified in the Scientific Agenda of the PACTG--CORC and in the RFA. The three primary goals are (1) to decrease mother-to-infant transmission of HIV to less than 2%; (2) to achieve a 90% 10 year survival for children perinatally infected with HIV and (3) to develop novel strategies for early treatment Of newly infected infants and adolescents. The PACTU will conduct Phase I, II and Ill clinical studies with the PACTG. The PACTU has available a significant number of HIV infected patients for possible study. Each year there are 50 new pregnant women, 40 new children and 20 new adolescents and young adults. The PACTU also follows 245 children and 85 adolescents and young adults who are potential candidates for studies.. The PACTU has four years of experience with Phase I, II and II, ACTG studies involving perinatal transmission, primary therapy, opportunistic infections, immune based therapy and long-term follow-up. Accrual has always been above target and the quality of data has been excellent. The PACTU is particularly active in studies to reduce perinatal transmission and has submitted concept sheets and capsules to the ACTG and has conducted supplemental investigations in this area of research. Members of the PACTU serve in leadership positions of the PACTG. The PACTU supports the Scientific Agenda of the CORC by participating in developing, monitoring and revising the Scientific Agenda; serving in leadership positions on the RACs and Committees; submitting capsules and concept sheets for clinical and more fundamental studies; conducting the research protocols of the RACs and Committees; serving on protocol teams; conducting supplemental investigations; and participating in the reporting of results through meetings and scientific publications.

华盛顿特区地区儿科艾滋病临床研究中心 (PACTU) 将作为儿科艾滋病治疗小组的成员 (PACTG) 与协调和运营中心 (CORC) --Spector。 PACTU 的目标和具体目标与那些相同 PACTG--CORC 的科学议程和 RFA 中确定了这一点。 三个主要目标是 (1) 减少母婴传播 HIV 传播率低于 2%； (2) 10年实现90% 围产期感染艾滋病毒的儿童的生存率和 (3) 发育 早期治疗新感染婴儿的新策略和 青少年。 PACTU将进行I期、II期和III期临床 与 PACTG 一起研究。 PACTU 拥有大量可用的 HIV感染者的可能研究。每年都会有50个新 孕妇、40 名新生儿和 20 名青少年和年轻人 成年人。 PACTU 还跟踪了 245 名儿童和 85 名青少年 潜在的学习候选人的年轻人.. PACTU 已 四年 I、II 和 II 期 ACTG 研究经验 涉及围产期传播、主要治疗、机会性传播 感染、免疫治疗和长期随访。应计有 始终高于目标，并且数据质量非常出色。 PACTU 特别积极致力于减少围产期的研究 传输并向 ACTG 提交了概念表和胶囊 并对该研究领域进行了补充调查。 PACTU 成员担任 PACTG 的领导职务。这 PACTU 通过参与以下活动来支持 CORC 的科学议程 制定、监测和修订科学议程；服务于 RAC 和委员会的领导职位；提交胶囊 以及临床和基础研究的概念表； 执行 RAC 和委员会的研究方案；服务 礼宾团队；进行补充调查；和 通过会议和参与结果报告 科学出版物。