Alabama-Clinical Trials Unit

阿拉巴马州临床试验单位

• 批准号: 8116816
• 负责人: Michael S. Saag
• 金额: $ 51.82万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-02 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8116816
• 关键词: AIDS Vaccines; AIDS clinical trial group; AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adolescent; Adult; African American; Alabama; Area; Basic Science; Caring; Childhood; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Unit; Commit; Communities; Comorbidity; Epidemic; Failure; Funding; HIV; HIV Infections; HIV Vaccine Trials Network; HIV prevention trials network; HIV vaccine; Heart; Individual; Industry; Infant; Infection; Investigation; Mothers; National Institute of Allergy and Infectious Disease; Participant; Patients; Populations at Risk; Prevention; Prevention Research; Preventive Intervention; Research; Research Personnel; Resources; Site; Southeastern United States; Therapeutic; Toxic effect; United States; Universities; Vaccine Research; Vaccines; Vertical Disease Transmission; Virus; Vulnerable Populations; Woman; antiretroviral therapy; clinical research site; drug development; experience; microbicide; pediatric AIDS; response; success; vaccine evaluation

DESCRIPTION (provided by applicant): Despite the tremendous progress in the treatment and prevention of HIV infection in the United States there remain significant deficiencies in care and prevention. Antiretroviral therapy failure occurs, unexpected toxicities have emerged, long-term secondary complications have arisen, mother-to-child transmission still befalls mothers and infants in resource poor settings, and the rate of infection continues unabated. The Southeastern United States has the fastest rising number of new HIV infections in the U.S., particularly among African American women. This places Alabama and the University of Alabama Birmingham (UAB) in the heart of this growing epidemic that disproportionately afflicts the most vulnerable populations. This is confounded by the fact that an estimated 50% of infected individuals in this region are unaware they are carrying the virus. The UAB Center for AIDS Research (CFAR) has been at the forefront of HIV prevention and therapeutic investigation for over 18 years. The UAB CFAR is committed to providing the most modern, up to date, therapeutic and prevention interventions to patients and at-risk populations in our State. In response to the NIAID's call for site applications to perform clinical studies that address the emerging issues in HIV treatment and prevention, the UAB CFAR has formed the Alabama-Clinical Trials Unit (A-CTU): A partnership of UAB investigators dedicated to the conduct of high-impact HIV-related studies in a resource poor region of the United States. The A-CTU is comprised of an efficient Central Administration and four Clinical Research Sites (CRS): Alabama Therapeutics-CRS (AT-CRS), The Alabama Vaccine-CRS (AV-CRS), The Alabama Pediatric, Adolescent & Maternal-CRS (APAM-CRS), and The Alabama Microbicide-CRS (AM-CRS). The A-CTU draws on tremendous experience and success in NIAID-sponsored research trials groups, including over 13 years of involvement in the Adult and Pediatric AIDS Clinical Trials Group (AACTG; PACTG), 12 years experience in the HIV Prevention Trials Network (HPTN), and 11 years of continuous involvement as a federally funded HIV vaccine trials site under the AIDS Vaccine Evaluation Group and the HIV Vaccine Trials Network. Owing to this wealth of experience, we are submitting this single coordinated CTU application in response to 5 of the 6 High-Profile Targeted Areas of Investigation: Vaccine research, translational and drug development research, optimization of clinical management research (including comorbidities), microbicide research, and prevention of mother-to-child transmission research. Addressing these Priority Areas will be accomplished through utilization of the A-CTU's genuine partnership with the patient/participant community, its experience in NIAID and industry-funded clinical trials, and through collaborative research among clinical and basic science investigators within the UAB CFAR. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：尽管在美国治疗和预防艾滋病毒感染方面取得了巨大进展，但在护理和预防方面仍然存在很大的缺陷。发生抗逆转录病毒疗法衰竭，出现意外的毒性，长期的继发并发症已经出现，母亲到孩子的传播仍然使母亲和婴儿在资源较差的环境中降临，并且感染率持续不断。美国东南部的新艾滋病毒感染数量最快，尤其是在非洲裔美国妇女中。这使阿拉巴马州和阿拉巴马大学伯明翰大学（UAB）置于这种日益增长的流行病的核心，这造成了最脆弱的人群的不成比例。这一事实使这一事实感到困惑，即该地区的感染者中有50％的人没有意识到他们正在携带病毒。 UAB AIDS研究中心（CFAR）一直在预防HIV和治疗研究的最前沿。 UAB CFAR致力于为我们州的患者和高危人群提供最新，最新，治疗和预防干预措施。为了响应NIAID呼吁进行现场应用来进行临床研究，以解决艾滋病毒治疗和预防中新兴问题的临床研究，UAB CFAR成立了阿拉巴马州临床试验单位（A-CTU）：UAB研究人员的合作伙伴关系，致力于进行高影响艾滋病毒较差的研究，以在艾滋病毒较差的地区进行艾滋病毒研究。 美国。 A-CTU由有效的中央给药和四个临床研究组成 站点（CRS）：阿拉巴马州Therapeutics-CRS（AT-CRS），阿拉巴马州疫苗CRS（AV-CRS），阿拉巴马州儿科，青少年和母体-CRS（APAM-CRS）以及阿拉巴马州的杀菌剂（APAM-CRS）以及杀人型菌方（AM-CRS）。 A-CTU借鉴了NIAID赞助的研究试验小组的巨大经验和成功，包括超过13年的成人和小儿AIDS临床试验小组（AACTG； PACTG），在HIV预防试验网络（HPTN）中的12年经验，以及11年的经验和11年的持续疫苗，作为一项持续的HEIV疫苗接种式疫苗接种式疫苗接种式疫苗接种量，试验网络。由于这种丰富的经验，我们正在提交这项协调的CTU应用，以响应6个备受瞩目的针对性调查领域中的5个：疫苗研究，转化和药物开发研究，临床管理研究的优化（包括合并症），微生物剂研究以及对母亲到孩子至孩子传播研究的预防。解决这些优先领域的问题将通过利用A-CTU与患者/参与者社区的真正合作伙伴关系，其在NIAID和行业资助的临床试验中的经验以及UAB CFAR中临床和基础科学研究人员的合作研究。 管理组件：