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。Baylor（现为儿科艾滋病临床试验组[PACTG]，临床研究中心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.布鲁克斯杰克逊，医学博士，工商管理硕士，主要研究者[PI]，PACTG合并的新小组和艾滋病预防试验网络的围产期部分）评为“高度首选”临床试验单位。IMPAACT选择中包括的因素包括：1）证明有能力在临床试验中招募和保留合适的人群，2）研究中心研究者对PACTG委员会和方案/实施活动的贡献，以及3）研究中心研究者的生产性出版记录的证据。贝勒IMPAACT CTU将有两个患者资源：1）贝勒医学院儿科过敏和免疫科的德克萨斯儿童医院（TCH）研究中心（首席研究员William T.希勒，医学博士，博士，科长和贝勒医学院儿科逆转录病毒科（现场共同负责人，马克W。克莱恩，医学博士，科长）;和2）托马斯街诊所（TSC），医学系，贝勒医学院（现场负责人，托马斯P.佐丹奴，医学博士，公共卫生硕士，医学主任）。HIV感染患者可进入IMPAACT临床试验，该试验针对4个重点优先领域：1）预防母婴HIV传播，2）转化研究和药物开发，3）优化临床管理，包括合并症，以及4）预防性传播HIV的疫苗。由于其与10多个NIH，CDC和过渡性艾滋病研究的私人来源建立网络的能力，以及其对促进预防和治疗方案和发病机制的理解的贡献，贝勒将能够为NIH HIV/AIDS临床试验网络做出重大贡献，特别是针对迅速扩大的HIV感染青少年人口的协议。 行政部门：

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: