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年成立以来一直作为洛杉矶的儿科艾滋病临床试验单位和自2000年以来作为巴西的艾滋病预防试验单位得到NIH的资助。我们提议成立加州大学洛杉矶分校/巴西艾滋病联盟CTU（UCLA-LABAC-CTU），其中洛杉矶的5个国内研究中心作为IMPAACT的附属联盟参加，5个巴西研究中心参加多个网络（IMPAACT、HPTN和AACTG）。由独立评审员和网络领导人选择拟议的UCLA CTU附属临床研究中心作为各自网络（IMPAACT、HPTN、AACTG）的首选研究中心。我们的具体目标包括招募大量艾滋病毒感染和高危婴儿，儿童，青少年和成人进入与NIH网络相关的高优先级临床试验，为NIH科学议程做出贡献，维护附属CRS的行政和财务，科学和数据，监管和实验室监督，以及维护和扩大我们的社区外展和CAB。洛杉矶财团包括加州大学洛杉矶分校，长滩纪念，港口加州大学洛杉矶分校，儿童医院洛杉矶和儿童医院橙子县。该联合体是地理和种族多样性人口（每年超过1 000名艾滋病毒感染者/儿童/青少年和超过150名艾滋病毒感染者/孕妇）的主要汇集区。加州大学洛杉矶分校一直担任主要的行政，数据输入，实验室，CAB和指导小组。这导致临床试验经验和经济效益方面的成功微不足道。自1989年以来，我们在71个I期、II期和III期围产期儿科HIV试验中展开了826例患者，具有出色的保留率、数据质量和出版记录。在巴西，我们的集团包括里约热内卢的HSE医院，波尔图阿莱格雷的3个地点（Concoicao，Santa Casa和Femina医院）和圣保罗的1个地点（联邦大学）。10个均为UCLA-HPTN位点，20个同时为PACTG和AACTG位点。这些研究中心在临床试验中招募了>900名受试者（265名入组HPTN 040 MTCT）。另外五项由NIH赞助的试验将于今年启动。所有巴西CRS都建议加入IMPAACT，2个加入AACTG和HPTN。这些站点照顾1 700名感染艾滋病毒的儿童、900名青少年、800名孕妇，AACTG站点有4 700名受感染的成年人，并可接触大量血清反应阴性的高危成年人。LABAC CTU和CRS是成功的单位，具有开展复杂和多中心NIH网络试验所需的基础设施和经验。 行政部门：

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: