Project Summary/Abstract The currently funded Emory-CDC Clinical Trials Unit (Emory-CDC CTU) is ideally positioned to implement the mission of NIAID and to conduct clinical trials developed by the NIH HIV/AIDS Clinical Trials Networks. The Emory-CDC CTU is supported by Emory’s rich scientific milieu with numerous synergistic grants and various thematic research centers covering all network priority areas, as well as the support and experience of our CDC partners. The Emory-CDC CTU is comprised of 5 CRSs with well-established programs and histories of performing NIH funded clinical research. In this renewal the Emory-CDC CTU will be expanding to a 6th CRS in Mexico City. Our specific aims are the following: 1. To contribute scientific expertise and human subject enrollment into studies that address these four key research areas: Adult HIV therapeutic strategies, including HIV cure, noninfectious comorbidities, and the infectious comorbidities of hepatitis and tuberculosis; strategies to address HIV and HIV-associated infections in pediatric and maternal populations; integrated HIV prevention strategies; and vaccines to prevent HIV infection. 2. To be a leading CTU for contributions of women, minorities, and adolescents to support network clinical trials, both domestically and in low and middle-income countries. 3. To operate an efficient and flexible CTU that can respond rapidly to evolving research opportunities. 4. To participate in the development and implementation of the clinical research plans of all the NIAID clinical research networks that are addressing the four priority areas.

Project Narrative The Emory-CDC Clinical Trials Unit is well positioned to contribute to the mission of the NIH HIV/AIDS Clinical Trials Networks due to our extensive experience in conducting clinical trials related to Hepatitis/TB/HIV vaccine, prevention, and treatment both domestically and internationally. We are well suited to participate in pediatric maternal and adult populations. Through our partnerships with the CDC, and our diverse scientific collaborators, we are poised to help develop and implement the next generation of network research plans.