Baylor College of Medicine Clinical Trial Unit

描述（由申请人提供）：贝勒医学院（贝勒）正在申请一个临床试验单位（CTU），以响应NIH RFA-AI-05-002单位的艾滋病毒/艾滋病临床试验网络。贝勒（目前是儿科艾滋病临床试验组[PACTG]，临床站点3801）被国际孕产妇，儿科和青少年艾滋病临床试验（IMPAACT）网络领导小组（J. Brooks Jackson，医学博士，MBA，首席研究员[PI]， PACTG合并的新小组，以及HIV预防试验网络的围产期组成部分）列为“高度首选”临床试验单位。入选IMPAACT的因素包括：1)在临床试验中招募和保留合适人群的能力；2)现场研究者对PACTG委员会和协议/实施活动的贡献；3)现场研究者有成果发表记录的证据。贝勒IMPAACT CTU将有两种患者资源：1)贝勒医学院儿科过敏和免疫学科的德克萨斯儿童医院（TCH）研究中心（首席研究员，William T. Shearer，医学博士，科主任）和贝勒医学院儿科逆转录病毒科（网站共同负责人，Mark W. Kline，医学博士，科主任）；2)贝勒医学院医学系托马斯街诊所（TSC）（网站负责人，托马斯P.佐丹奴，医学博士，公共卫生硕士，医学主任）。加上这些患者，贝勒医院将有280名患者，其中大部分是青少年。艾滋病毒感染患者可进入IMPAACT临床试验，该试验针对4个高度优先的重点领域：1)预防母婴艾滋病毒传播；2)转化研究和药物开发；3)优化临床管理，包括合并症；4)预防艾滋病毒性传播的疫苗。由于它有能力与超过10个NIH、CDC和过渡性艾滋病研究的私人来源建立网络，以及它对促进对预防、治疗方案和发病机制的理解的贡献，贝勒将能够对NIH艾滋病毒/艾滋病临床试验网络做出强有力的贡献，特别是针对迅速扩大的艾滋病毒感染青少年人口的协议。

DESCRIPTION (provided by applicant): Baylor College of Medicine (Baylor) is applying for a Clinical Trials Unit (CTU) in response to NIH RFA-AI-05-002 Units for HIV/AIDS Clinical Trials Networks. Baylor (presently Pediatric AIDS Clinical Trials Group [PACTG], Clinical Site 3801) was ranked by the International Maternal, Pediatric, and Adolescent AIDS Clinical Trials (IMPAACT) Network Leadership Group (J. Brooks Jackson, MD, MBA, Principal Investigator [PI], the merged new group of the PACTG, and the perinatal component of the HIV Prevention Trials Network as a "Highly Preferred" Clinical Trials Unit. Factors included in the IMPAACT selection included: 1) demonstrated ability to enroll and retain suitable populations in clinical trials, 2) contributions by site investigators to PACTG committee and protocol/implementation activities, and 3) evidence of a productive publication record by the site's investigators. The Baylor IMPAACT CTU will have two resources of patients: 1) Texas Children's Hospital (TCH) research home of the Section of Allergy and Immunology, Department of Pediatrics, Baylor College of Medicine (Principal Investigator, William T. Shearer, MD, PhD, Section Chief; and the Section of Retrovirology, Department of Pediatrics, Baylor College of Medicine (Site Co-Leader, Mark W. Kline, MD, Section Chief); and 2) Thomas Street Clinic (TSC), Department of Medicine, Baylor College of Medicine (Site leader, Thomas P. Giordano, MD, MPH, Medical Director).With these combined number of patients, the Baylor will have 280, mostly adolescents. HIV-infected patients available for entry into IMPAACT clinical trials designed for 4 high priority areas of focus: 1) Prevention of mother-to-child HIV transmission, 2) Translational Research and Drug Development, 3) Optimization of Clinical Management, including co-morbidities, and 4) Vaccines for Prevention of sexual HIV transmission. Because of its ability to network with over 10 NIH, CDC, and private sources of transitional AIDS research, and its contribution to advancing the understanding of prevention and treatment regimens and pathogenesis, Baylor will be able to make a strong contribution to the NIH HIV/AIDS Clinical Trials Network, particularly protocols targeted to the rapidly expanding HIV-infected adolescent population. ADMINISTRATIVE COMPONENT: