Alabama-Clinical Trials Unit

描述(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的进步，但在护理和预防方面仍然存在重大缺陷。抗逆转录病毒治疗失败，出现了意想不到的毒性，出现了长期的继发性并发症，母婴传播仍然发生在资源匮乏的环境中，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，特别是在非裔美国女性中。这将阿拉巴马州和阿拉巴马大学伯明翰分校(UAB)置于这一日益增长的流行病的中心，这一流行病对最脆弱的人群造成了不成比例的痛苦。这一点令人困惑，因为据估计，该地区50%的感染者不知道自己携带病毒。 UAB艾滋病研究中心(CFAR)18年来一直站在艾滋病毒预防和治疗研究的前沿。UAB CFAR致力于为我们州的患者和高危人群提供最现代、最新的治疗和预防干预措施。为了响应NIAID要求现场申请进行临床研究以解决艾滋病毒治疗和预防方面的新问题，UAB CFAR成立了阿拉巴马州临床试验单位(A-CTU)：UAB调查人员的合作伙伴关系，致力于在资源匮乏的地区进行与艾滋病毒有关的高影响研究 美国。A-CTU由一个高效的中央管理机构和四个临床研究组成 网站(CRS)：阿拉巴马州治疗CRS(AT-CRS)、阿拉巴马州疫苗CRS(AV-CRS)、阿拉巴马州儿科、青少年和母亲CRS(APAM-CRS)和阿拉巴马州杀微生物剂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，包括参与成人和儿童艾滋病临床试验小组(AACTG；PACTG)超过13年，在艾滋病毒预防试验网络(HPTN)工作12年，以及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地点持续参与11年。由于这一丰富的经验，我们提交这一协调一致的CTU申请，以回应6个备受瞩目的目标调查领域中的5个：疫苗研究、转化和药物开发研究、临床管理研究的优化(包括合并症)、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/参与者社区的真正伙伴关系、其在NIAID和行业资助的临床试验方面的经验，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。 管理组件：

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: