Longitudinal Study of Ocular Complications of AIDS (LSOCA)

Study Overview
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Brief Summary
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To monitor trends over time, in the incidence of CMV retinitis and other ocular complications of AIDS To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune status on the risk of developing CMV retinitis and other ocular complications of AIDS To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a population at high risk for CMV retinitis and other ocular complications of AIDS To evaluate the effects of treatments for CMV retinitis and other ocular complications on visual function, quality of life, and survival.

Detailed Description
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Ocular abnormalities in patients with AIDS were first reported in 1982. The most common finding is a non-infectious HIV retinopathy, characterized by cotton wool spots, intraretinal hemorrhages, and/or microaneurysms. These changes occur in approximately 50 percent of patients with AIDS. HIV retinopathy alone is not typically associated with clinical loss of vision, but functional deficits in patients with AIDS without other ocular complications may be due to this phenomenon. CMV retinitis has had the most clinical importance of all the associated complications of AIDS. It is commonly seen in late stage AIDS, and even when treated has the potential to cause substantial loss of vision. CMV retinitis is also the most costly AIDS-related opportunistic infection; the mean monthly cost of treatment has been estimated at $7,825. The incidence of CMV retinitis has varied with changes in the therapeutic and prophylactic strategies for AIDS and its complications. It has been on the decline in recent years related to the increased use of highly active anti-retroviral therapy (HAART). Other ocular complications of AIDS such as ocular toxoplasmosis, herpes zoster retinitis, and pneumocystis choroidopathy occur less frequently than CMV retinitis and HIV retinopathy. Their frequency has also changed over the course of the AIDS epidemic. Because the epidemiology of AIDS is rapidly evolving, with HIV becoming more like a chronic disease, new information is needed on the incidence and course of ocular complications. We have little information about the effect of HAART therapy over time on changes in immune status and the risk of ocular complications of AIDS. More information is also needed to determine who is at risk for developing ocular complications of AIDS, and how treatment is affecting their visual function, quality of life, and survival. The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is prospective observational study of patients with AIDS. Patients with a prior diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention (CDC) criteria with or without ocular complications will be enrolled over a 4 year period. Approximately 2,000 patients will be enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. Followup visits for patients without ocular complications will be scheduled every 6 months. Followup visits for patients with ocular complications at baseline or diagnosed during followup will be every 3 months. Followup data will include eye examinations, fundus photographs, visual function testing, medical history, hematology and serum chemistry, and collection of plasma and blood cells for banking. Analysis of banked specimens will include HIV RNA levels and CMV DNA levels.

Official Title
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Studies of Ocular Complications of AIDS (SOCA)

Conditions
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HIV Infections, Acquired Immunodeficiency Syndrome, Cytomegalovirus Retinitis

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: A diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention (CDC) definition (with or without clinical symptoms of CMV retinitis or other ocular complications of AIDS) Age 13 years or older Signed consent statement Patients with newly diagnosed (within 45 days of enrollment) Ocular Opportunistic Infections (OOIs) Patients without a newly diagnosed Ocular Opportunistic Infection (OOI) diagnosed with AIDS after 1 Jan 2001 Exclusion criteria: - none.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of CMV retinitis, other ocular complications, mortality. |  | Until one year after the enrollment of the last patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of sequelae of AIDS-related eye disease (e.g., retinal detachments), incidence of complications of therapy, and long-term outcomes of ocular complications (e.g., visual function, quality of life). |  | Until one year after the enrollment of the last patient. |