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年成立以来一直是美国国立卫生研究院资助的洛杉矶儿科艾滋病临床试验单位，自2000年以来一直是巴西艾滋病预防试验单位。我们建议UCLA洛杉矶/巴西艾滋病联盟CTU (UCLA- labac -CTU)，其中洛杉矶的5个国内站点作为IMPAACT附属的一个联盟参与，5个巴西站点参与多个网络（IMPAACT， HPTN和AACTG）。建议的UCLA ctu附属临床站点由各自的网络（IMPAACT， HPTN， AACTG）由独立审查员和网络领导选择为首选站点。我们的具体目标包括招募大量HIV感染者和高危婴儿、儿童、青少年和成人参与与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、长滩纪念医院、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。该联盟是地理和种族多样化人口（每年1000名艾滋病毒暴露/感染儿童/青少年和150名感染艾滋病毒的孕妇）的主要汇水区。加州大学洛杉矶分校作为主要的行政管理、数据录入、实验室、CAB和团队的导师。这在临床试验经验和经济效益方面取得了微不足道的成功。自1989年以来，我们在71项I、II和III期围产儿艾滋病试验中纳入了826名患者，具有出色的保留性、数据质量和发表记录。在巴西，我们的集团包括位于2010年的HSE医院，位于阿雷格里港的3家医院（康科伊奥、圣卡萨和费米纳医院），以及位于圣保罗的1家医院（联邦大学）。所有都是已建立的UCLA-HPTN站点，其中2个也是PACTG和AACTG站点。这些站点已经招募了900名受试者进行临床试验（265名受试者参与了hptn040 MTCT试验）。美国国立卫生研究院资助的另外五项试验也将于今年启动。所有巴西CRS都建议与IMPAACT和AACTG和HPTN建立联系。这些站点照顾1700名感染艾滋病毒的儿童、900名青少年和800名孕妇，AACTG站点有4 700名受感染的成年人，并可接触到大量血清呈阴性的高危成年人。LABAC CTU和CRS是成功的单位，具有进行复杂和多中心NIH网络试验所需的基础设施和经验。

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: