UCLA Los Angeles Brazil AIDS Consortium

加州大学洛杉矶分校洛杉矶分校巴西艾滋病联盟

• 批准号: 7577361
• 负责人: Yvonne J. Bryson
• 金额: $ 313.09万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7577361
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Adolescent; Adult; Brazil; Caring; Catchment Area; Child; Clinical Trials; Clinical Trials Unit; Community Outreach; Complex; County; Data; Data Quality; Economics; Enrollment; Funding; HIV; HIV prevention trial; Hospitals; IMPAACT; Infant; Laboratories; Leadership; Los Angeles; Mentors; Oranges; Patients; Pediatric Hospitals; Perinatal; Phase; Population Heterogeneity; Pregnant Women; Publications; Records; Research Infrastructure; Risk; Site; United States National Institutes of Health; Universities; clinical research site; cohort; experience; pediatric AIDS; pediatric human immunodeficiency virus; success

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:

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儿科艾滋病临床试验单位和自 2000 年以来作为巴西艾滋病毒预防试验单位得到 NIH 的资助。我们提议成立加州大学洛杉矶分校洛杉矶/巴西艾滋病联盟 CTU (UCLA-LABAC-CTU)，洛杉矶有 5 个国内站点作为 IMPAACT 附属联盟参与，并且 5 巴西站点参与多个网络（IMPAACT、HPTN 和 AACTG）。独立评审员和网络领导层将拟议的 UCLA CTU 附属临床中心选为各自网络（IMPAACT、HPTN、AACTG）的首选中心。我们的具体目标包括将大量艾滋病毒感染者和高危婴儿、儿童、青少年和成人纳入与 NIH 网络相关的高优先级临床试验，为 NIH 科学议程做出贡献，维持附属 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展和 CAB。洛杉矶联盟包括加州大学洛杉矶分校、长滩纪念馆、加州大学洛杉矶分校哈伯分校、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群（>1000 名艾滋病毒暴露/感染儿童/青少年和>150 名艾滋病毒感染孕妇/年）的主要集水区。加州大学洛杉矶分校担任该团体的主要行政、数据录入、实验室、CAB 和导师。这导致临床试验经验和经济效率方面取得了微不足道的成功。自 1989 年以来，我们在 71 个 I、II 期和 III 围产期儿科 HIV 试验，具有出色的保留率、数据质量和发表记录。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 个站点（Concoicao、Santa Casa 和 Femina 医院）以及圣保罗的 1 个站点（联邦大学）。所有站点均已建立 UCLA-HPTN 站点，另外 2 个站点也是 PACTG 和 AACTG 站点。这些网站已注册超过 900 个 临床试验受试者（265 名参加 HPTN040 MTCT）。今年还将启动另外五项由美国国立卫生研究院资助的试验。所有巴西 CRS 均提议加入 IMPAACT，2 加入 AACTG 和 HPTN。这些站点照顾 1700 名 HIV 感染儿童、900 名青少年、800 名孕妇，AACTG 站点照顾 4,700 名受感染的成年人，并接触到大量艾滋病病毒感染者。 血清阴性成人的风险。 LABAC CTU 和 CRS 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。 行政部分：