LONGITUDINAL STUDY OF OCULAR COMPLICATIONS OF AIDS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is a multi-center prospective, observational study of patients with AIDS. Patients with a diagnosis of AIDS according to the 1993 CDC criteria, with or without ocular complications, will be enrolled. The objectives of the study are: 1) to monitor secular trends in the incidence of ocular complications of AIDS; 2) to determine the effect of HAART-induced changes in immune status on the incidence and course of ocular complications of AIDS; 3) to determine the characteristics of patients that place them at high risk for ocular complications; and 4) to evaluate the effects of treatments for CMV retinitis and other ocular complications on visual functions, quality of life and survival. Approximately 2,000 patients will be enrolled in this study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. All patients will be on a 3-month follow-up schedule. For patients with a major ocular complication, all follow-up visits will be clinic visits. For patients without a major ocular complication, follow-up visits will alternate between telephone follow-up visits and clinic follow-up visits. Data will be collected from eye examinations, fundus photographs, visual function testing, medical history, quality of life assessments, laboratory studies and collection of plasma and blood cells for banking. Banked specimens will be analyzed for HIV RNA levels and CMV DNA levels. Outcomes of primary interest are incidence of CMV retinitis, incidence of other ocular complications and mortality. Other outcomes of interest include incidence of extra-ocular CMV disease, sequelae of AIDS-related eye disease ( e.g., retinal detachment), visual function, quality of life, and incidence of complications of therapies for ocular complications.