DESCRIPTION (provided by the applicant): Through this application Emory University, Duke University, the Orlando Immunology Center, and the Centers for Disease Control and Prevention (CDC) are proposing an integration of eight existing, highly productive HIV research sites. The administrative core of the Emory, Duke, Orlando, CDC Clinical Trials Unit (EmDOC CTU) will be located at Emory University. The CTU will be led by three Principal Investigators: Carlos del Rio, Jeffrey Lennox, and Mark J. Mulligan. The CTU will include four Southeastern US research sites (2 located in Atlanta, one in Durham, and one in Orlando) and four international research sites (Botswana, Kenya, Tanzania, and Thailand). All of these sites are currently performing complex clinical trials in areas of the United States and internationally that are hard hit by the HIV epidemic, as well as by the concomitant epidemics of TB and viral hepatitis, and have access to diverse heavily affected populations. The Specific Aims of the Project are: 1. To contribute scientific expertise and human subject enrollment into studies that address these six 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; Microbicide strategies to prevent HIV infection; Vaccines to prevent HIV infection; and Strategies to address antibacterial resistance. 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 of the NIAID clinical research networks that are addressing the six priority research areas.

RELEVANCE: The CTU, working with the clinical research networks, will contribute to the development of improved strategies for the treatment and potential cure of HIV infection, to the treatment of TB and viral hepatitis, to improved methods for the prevention of HIV, and to improved treatments for antibiotic resistant infections. This CTU will contribute to improving the health of both the American public and the international public.