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）：尽管美国在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存在重大缺陷。抗逆转录病毒疗法失败，出现了意想不到的毒性，出现了长期的继发性并发症，在资源贫乏的环境中，母婴传播仍然发生在母亲和婴儿身上，感染率继续有增无减。美国东南部是美国新增艾滋病毒感染人数增长最快的地区，尤其是非洲裔美国女性。这使得亚拉巴马和亚拉巴马伯明翰大学（UAB）处于这种日益严重的流行病的中心，这种流行病不成比例地折磨着最脆弱的人群。令人困惑的是，该地区估计有50%的感染者不知道自己携带病毒。 UAB艾滋病研究中心（CFAR）已经在艾滋病毒预防和治疗研究的最前沿超过18年。UAB CFAR致力于为我们州的患者和高危人群提供最现代化，最新的治疗和预防干预措施。为了响应NIAID的呼吁，进行临床研究，解决艾滋病毒治疗和预防中出现的问题，UAB CFAR成立了UAB临床试验单位（A-CTU）：UAB研究人员的伙伴关系，致力于在资源贫乏的地区进行高影响力的艾滋病毒相关研究。 美国的A-CTU由一个高效的中央管理部门和四个临床研究部门组成。 研究中心（CRS）：亚拉巴马治疗-CRS（AT-CRS）、亚拉巴马疫苗-CRS（AV-CRS）、亚拉巴马儿童、青少年和母亲-CRS（APAM-CRS）和亚拉巴马杀微生物剂-CRS（AM-CRS）。 A-CTU借鉴了NIAID赞助的研究试验小组的丰富经验和成功，包括参与成人和儿科艾滋病临床试验小组超过13年（AACTG; PACTG），在艾滋病毒预防试验网络（HPTN）有12年的经验，以及11年来作为艾滋病疫苗评估小组和艾滋病毒疫苗试验网络下的联邦资助的艾滋病毒疫苗试验网站的持续参与。由于这些丰富的经验，我们正在提交这一单一的协调CTU申请，以回应6个高知名度目标调查领域中的5个：疫苗研究，转化和药物开发研究，临床管理研究（包括合并症）的优化，杀微生物剂研究和预防母婴传播研究。解决这些优先领域将通过利用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，以及通过UAB CFAR内临床和基础科学研究人员之间的合作研究来实现。 行政部门：