This proposal is written in response to an NHLBI FOA requesting a Data Coordinating Center (DCC) for RFA-HL-08-003 Mechanisms and Management of Cardiovascular and Metabolic Complications of HIV/AIDS. The purpose of the FOA is to foster collaborative research to elucidate the underlying mechanisms of metabolic and anthropometric abnormalities seen in HIV infection and highly active antiretroviral therapy and their relationship to cardiovascular disease risk. In this application, we propose to run the DCC from the Collaborative Health Studies Coordinating Center (CHSCC) at the University of Washington. The DCC will be responsible for coordinating studies at 6-7 clinical sites engaged in separate, but complimentary research agendas. Although the studies will all involve research that addresses the title of this RFA, the size and scope of these studies has yet to be fully determined. The DCC will play a key role in coordination and management of these studies. Its key responsibilities will include facilitation of data harmonization, standardization of study protocols where appropriate, facilitating data and specimen banking, scheduling and facilitating investigator meetings, coordinating centralized readings of cardiac evaluations and providing statistical expertise and support in protocol development, data analysis and preparation of presentations and manuscripts. This application describes our relevant experience and preparedness in these areas as well as others crucial to efficiently running a DCC. It also presents our plans for running the DCC for this group of studies.
HIV-infected individuals have increased life expectancies since the introduction of highly active antiretroviral therapy (HAART). With this increased life expectancy come increased incidences of metabolic complications and cardiovascular disease (CVD) associated with living with HIV/AIDS and prolonged exposure to HAART. Studying how these diseases interact with HIV and HAART can help prevent their development and progression in HIV-infected individuals.
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