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.

Condition	Treatment or Intervention
HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis	Drug: Highly Active Anti-Retroviral Therapy (HAART)

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Males and females age 13 years and older with diagnosis of AIDS will be eligible

Curtis L. Meinert, Ph.D.      1-410-955-8198 

California
      Jules Stein Eye Institute, Los Angeles,  California,  90095-7003,  United States; Recruiting
      Shiley Eye Center, 0946, La Jolla,  California,  92093-0946,  United States; Recruiting
      Francis I. Proctor Foundation, San Francisco,  California,  94143,  United States; Recruiting
      University of Southern California, Los Angeles,  California,  90033,  United States; Recruiting
      University of California, Irvine, Irvine,  California,  92697-4375,  United States; Recruiting
Florida
      Bascom Palmer Eye Institute, Miami,  Florida,  33136,  United States; Recruiting
      University of South Florida, Tampa,  Florida,  33612-4799,  United States; Recruiting
Georgia
      Emory Eye Clinic, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Indiana
      Division of Infectious Diseases, University of Indiana, Indianapolis, Indianapolis,  Indiana,  46202-2879,  United States; Recruiting
Louisiana
      LSU Eye Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Maryland
      The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine, Baltimore,  Maryland,  21287-9217,  United States; Recruiting
New Jersey
      UMDNJ-New Jersey Medical School, Newark,  New Jersey,  07103-2499,  United States; Recruiting
New York
      Department of Ophthalmology, New York,  New York,  10021,  United States; Recruiting
      Department of Ophthalmology, New York,  New York,  10016,  United States; Recruiting
North Carolina
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7040,  United States; Recruiting
Pennsylvania
      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Texas
      Cullen Eye Institute, Houston,  Texas,  77030,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0835,  United States; Recruiting

Study ID Numbers:  NEI-71
Record last reviewed:  October 1999
Record first received:  September 23, 1999
ClinicalTrials.gov Identifier:  NCT00000168
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08