Clinical Investigation Core (CIC) will be established to serve the needs of all of the members of the NCCFAR. This core will advise users of trial design, prepare research protocols, assist in Investigational Review Board (IRB) and regulatory submission, conduct clinical research related to HIV and related infections, and keep all records needed in the performance of Good Clinical Practice (GCP). The CIC will be open to all members of the NCCFAR, and will be located with the NCCFAR at the Center for Aids Research, Education, and Services in Sacramento, California. The CIC will support all relevant research projects whose focus are on HIV-1 or related infections. The specific emphasis areas of the CIC have been determined to be those that will maximize the research activities of the probable users, both established and junior faculty. These will be to: A. Conduct trials that will evaluate HIV-1 vaccines, and to test vaccine concepts using novel adjuvants, vectors, or delivery systems; B. Conduct studies on immune response function and immunologic restoration during HIV-1 infection; C. Assess virologic correlates of disease progression; D. Study and improve outreach to patient populations and health care providers, especially minority, migrants, and the rural populations; E. Perform health services research to study the effectiveness and cost-benefit of our care and interventions; F. Foster studies in HIV-1 and STD prevention research, including prevention of the related conditions that may increase high-risk behavior, such as injecting drug use; G. Conduct studies in infections, malignancies, or other conditions related to HIV-1 infection or therapy; H. Foster mentoring of junior and foreign investigators; and I. Assist in pharmacologic studies of HIV therapies.
