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）：尽管美国在艾滋病毒感染的治疗和预防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。抗逆转录病毒治疗失败时有发生，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，尤其是非洲裔美国妇女。这使得阿拉巴马州和阿拉巴马大学伯明翰分校（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了病毒。