UCLA Los Angeles Brazil AIDS Consortium

描述(由申请人提供)：加州大学洛杉矶分校自1988年成立以来，一直由美国国立卫生研究院资助，作为洛杉矶的儿科艾滋病临床试验单位，并自2000年以来作为巴西的艾滋病毒预防试验单位。我们建议成立加州大学洛杉矶分校/巴西艾滋病联盟(UCLA-LABAC-CTU)，洛杉矶的5个国内站点作为IMPAACT的附属联合体参加，巴西的5个站点参与多个网络(IMPAACT、HPTN和AACTG)。建议的加州大学洛杉矶分校CTU附属临床站点被各自的网络(IMPAACT、HPTN、AACTG)选为首选站点，由独立审查员和网络领导层选择。我们的具体目标包括招募大量感染艾滋病毒和有风险的婴儿、儿童、青少年和成人参加与NIH网络相关的高优先级临床试验，为NIH的科学议程做出贡献，保持对附属CRS的行政和财务、科学和数据、监管和实验室监督，以及维持和扩大我们的社区外联和CAB。洛杉矶财团包括加州大学洛杉矶分校、长滩纪念馆、港湾-加州大学洛杉矶分校、洛杉矶儿童医院和奥兰治县儿童医院。该联合体是地理和种族多样化人口(&gt；1000名感染艾滋病毒的儿童/青少年和&gt；150名感染艾滋病毒的孕妇/年)的主要集散地。加州大学洛杉矶分校一直是该组织的主要行政、数据输入、实验室、CAB和导师。这导致了在临床试验经验和经济效益方面的不大成功。自1989年以来，我们在71个I、II和III期围产期儿童HIV试验中展开了826名患者，具有良好的保留率、数据质量和出版记录。在巴西，我们的团队包括里约热内卢的HSE医院，阿雷格里港的3个地点(Concoicao，Santa Casa和Femina医院)，以及圣保罗(联邦大学)的1个地点。均为UCLA-HPTN酶切位点，2个为PACTG和AACTG酶切位点。这些网站已经招募了900名受试者进行临床试验(265名受试者参加了HPTN040 MTCT)。另外五项由美国国立卫生研究院赞助的试验今年正在启动。所有巴西CRS都提议加入IMPAACT，2个加入AACTG和HPTN。这些网站照顾1700名感染艾滋病毒的儿童、900名青少年和800名孕妇，AACTG网站有4700名感染艾滋病毒的成年人，并接触到大量高危血清阴性成年人。LABAC CTU和CRS都是成功的单位，拥有进行复杂和多中心NIH网络试验所需的基础设施和经验。 管理组件：

DESCRIPTION (provided by applicant): UCLA has been NIH funded as a Pediatric AIDS Clinical Trials Unit for Los Angeles since its inception in1988 and as a HIV Prevention Trials Unit for Brazil since 2000. We propose the UCLA LA/BRAZIL AIDS consortium CTU (UCLA-LABAC-CTU) with 5 domestic sites in LA participating as a consortium affiliated with IMPAACT and 5 Brazilian sites participating in multiple networks (IMPAACT, HPTN and AACTG). The proposed UCLA CTU-affiliated clinical sites were chosen as preferred sites by the respective networks (IMPAACT, HPTN, AACTG) by independent reviewers and network leadership. Our specific aims include enrolling significant numbers of HIV infected and at risk infants, children, adolescents and adults into high priority clinical trials associated with NIH networks, contributing to the NIH scientific agenda, maintaining administrative and financial, scientific and data, regulatory and laboratory oversight of affiliated CRS and maintaining and expanding our community outreach and CAB. The LA consortium includes UCLA, Long Beach Memorial, Harbor-UCLA, Children's Hospital LA and Children's Hospital Orange County. This consortium is the major catchment area for geographically and ethnically diverse population (>1000 HIV-exposed / infected children / adolescents and >150 HIV-infected pregnant women/year. UCLA has functioned as the main administrative, data entry, laboratory, CAB and mentor for the group. This resulted insignificant success in clinical trials experience and economic efficiency. Since 1989 we unrolled 826 patients in 71 phase I, II & III perinatal pediatric HIV trials, with excellent retention, data quality and publication records. In Brazil, our group includes HSE hospital in Rio, 3 sites in Porto Alegre, (Concoicao, Santa Casa and Femina Hospitals), and 1 in Sao Paulo (Federal University). All are established UCLA-HPTN sites and 2are also PACTG and AACTG sites. These sites have enrolled >900 subjects in clinical trials (265 enrolled inHPTN040 MTCT). Five other NIH-sponsored trials are being initiated this year. All Brazil CRS propose affiliation with IMPAACT and 2 with the AACTG and HPTN. These sites care for 1700 HIV infected children,900 adolescents, 800 pregnant women, and the AACTG sites have 4,700 infected adults and access to large cohorts of at risk seronegative adults. The LABAC CTU and CRS are successful units with the infrastructure and experience needed for the conduct of both complex and multicenter NIH Network trials. ADMINISTRATIVE COMPONENT: