Longitudinal Study of Ocular Complications of AIDS (LSOCA)
- Conditions
- HIV InfectionsCytomegalovirus RetinitisAcquired Immunodeficiency Syndrome
- Registration Number
- NCT00000168
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2392
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of CMV retinitis, other ocular complications, mortality. Until one year after the enrollment of the last patient.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (18)
University of California, Irvine
🇺🇸Irvine, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
Francis I. Proctor Foundation
🇺🇸San Francisco, California, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Emory Eye Clinic
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Division of Infectious Diseases, University of Indiana, Indianapolis
🇺🇸Indianapolis, Indiana, United States
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
UMDNJ-New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Cullen Eye Institute
🇺🇸Houston, Texas, United States
Shiley Eye Center, 0946
🇺🇸La Jolla, California, United States
Department of Ophthalmology
🇺🇸New York, New York, United States
University of South Florida
🇺🇸Tampa, Florida, United States
LSU Eye Center
🇺🇸New Orleans, Louisiana, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States