This application proposes a training plan to develop John H. Kempen, MD, MPH into an independent clinical scientist, expert in epidemiologic research methods, especially clinical trials. As of July 1998, Dr. Kempen will be a board certified ophthalmologist with subspecialty training in uveitis. The Johns Hopkins University is exceptionally well suited to serve as his training site. The training program will consist of mentored research experience, multi-disciplinary conferences, and advanced course work, leading to a PhD in Epidemiology. Mentored research will be conducted as a member of the Studies of Ocular Complications of AIDS (SOCA) Research Group under primary mentor Prof. James Tonascia, co-director of the SOCA Coordinating Center, co-mentor Prof. Sheila West, a senior ophthalmic epidemiologist, and principal collaborator Dr. Douglas Jabs, SOCA Chair. Dr. Kempen will take part in the full spectrum of SOCA Coordinating Center activities, as well as assuming a leading role on the quality of life (QOL) and cost- effectiveness analysis (CEA) segments of the Ganciclovir-Cidofovir Cytomegalovirus Retinitis Trial (GCCRT). Dr. Albert Wu and Prof. Kevin Frick, experts in QOL and CEA respectively, will serve as consultants for this project. Cytomegalovirus (CMV) retinitis complicating the Acquired Immunodeficiency Syndrome (AIDS) is associated with reduced QOL and high treatment costs. The GCCRT is a phase IV multi-center randomized clinical trial comparing two non-central line dependent treatment strategies for CMV retinitis: intravitreal ganciclovir implant placement plus oral ganciclovir vs. intravenous cidofovir. As use of these regimens is largely driven by a desire to improve QOL, assessment of QOL outcomes will play a major role in interpreting trial results. Because of increasing interest in controlling the high costs of AIDS therapy, the GCCRT also will generate cost data prospectively, for CEA. The primary goals of these sections of the trial are to determine which treatment provides a better QOL, which is more costly, and to describe the cost-effectiveness of the more effective treatment. Subanalyses will assess what factors other than treatment strategy are associated with improved QOL and cost-effectiveness.
