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Trial NCT00000168

Resource URI: http://static.linkedct.org/resource/trials/NCT00000168
PropertyValue
linkedct:brief_title Longitudinal Study of Ocular Complications of AIDS (LSOCA)
linkedct:condition <http://static.linkedct.org/resource/condition/208>
linkedct:condition <http://static.linkedct.org/resource/condition/3546>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Males and females age 13 years and older with diagnosis of AIDS will be eligible
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 13 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000168
rdfs:label Trial NCT00000168
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:location <http://static.linkedct.org/resource/location/151094>
linkedct:location <http://static.linkedct.org/resource/location/152995>
linkedct:location <http://static.linkedct.org/resource/location/153274>
linkedct:location <http://static.linkedct.org/resource/location/160057>
linkedct:location <http://static.linkedct.org/resource/location/163735>
linkedct:location <http://static.linkedct.org/resource/location/166584>
linkedct:location <http://static.linkedct.org/resource/location/170337>
linkedct:location <http://static.linkedct.org/resource/location/173586>
linkedct:location <http://static.linkedct.org/resource/location/175648>
linkedct:location <http://static.linkedct.org/resource/location/184913>
linkedct:location <http://static.linkedct.org/resource/location/192507>
linkedct:location <http://static.linkedct.org/resource/location/197279>
linkedct:location <http://static.linkedct.org/resource/location/201888>
linkedct:location <http://static.linkedct.org/resource/location/203028>
linkedct:location <http://static.linkedct.org/resource/location/210154>
linkedct:location <http://static.linkedct.org/resource/location/210932>
linkedct:location <http://static.linkedct.org/resource/location/213259>
linkedct:location <http://static.linkedct.org/resource/location/214709>
linkedct:location <http://static.linkedct.org/resource/location/216378>
linkedct:nct_id NCT00000168
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NEI-71
linkedct:overall_contact_last_name Curtis L. Meinert, Ph.D.
linkedct:overall_contact_phone 1-410-955-8198
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000168>
linkedct:phase N/A
linkedct:source National Eye Institute (NEI)
linkedct:start_date August 1999
linkedct:study_design Natural History, Longitudinal, Prospective Study
linkedct:study_type Observational
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 1999