NEI Clinical Studies

Longitudinal Study of Ocular Complications of AIDS (LSOCA)

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Purpose | Background | Description | Patient Eligibility | Recruitment Status | Current Status | Results | Publications | Resource Centers | NEI Representative

Purpose

• 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.

Background

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.

Description

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.

Patient Eligibility

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

Patient Recruitment Status

Ongoing. A total of approximately 2,000 patients (300-600 of these will have been diagnosed with CMV retinitis prior to enrollment) will be recruited.

Current Status of Study

Ongoing.

Results

None.

Publications

None.

Resource Centers

Chairman's Office
Douglas A. Jabs, M.D., M.S. (Study Chair)
The Wilmer Ophthalmological Institute
The Johns Hopkins University School of Medicine
Department of Ophthalmology
550 North Broadway, Suite 700
Baltimore, MD 21205
Telephone: (410) 955-1966

Coordinating Center
Curtis L. Meinert, Ph.D.
Department of Epidemiology
School of Hygiene and Public Health
The Johns Hopkins University
615 North Wolfe Street, Room 5010
Baltimore, MD 21205
Telephone: (410) 955-8198

Fundus Photograph Reading Center
Matthew D. Davis, M.D.
Department of Ophthalmology
University of Wisconsin
610 North Walnut Street, Room 417
Madison, WI 53705-5240
Telephone: (608) 263-6071

Specimen Repository
James Stavinoha
Cryonix, Inc.
12401 Washington Avenue
Rockville, MD 20852
Telephone: (301) 881-2046

SOCA Website
http://www.jhsph.edu/Research/Centers/CCT/soca

NEI Representative

Natalie Kurinij, Ph.D.
National Eye Institute
National Institutes of Health
Executive Boulevard South, Suite 350
6120 Executive Boulevard MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5983
Fax: (301) 402-0528

Data and Safety Monitoring Committee

Ex Officio Members

Beverly M.D. Alston
National Institute of Allergy and Infectious Diseases
Bethesda, MD

Matthew D. Davis, M.D.
University of Wisconsin
Madison, WI

Douglas A. Jabs, M.D., M.S.
The Johns Hopkins University
Baltimore, MD

Natalie Kurinij, Ph.D.
National Eye Institute
National Institutes of Health
Bethesda, MD

Curtis L. Meinert, Ph.D.
The Johns Hopkins University
Baltimore, MD

James Tonascia, Ph.D.
The Johns Hopkins University
Baltimore, MD

Policy and Data Monitoring Board

Brian P. Conway, M.D.
University of Virginia
Charlottesville, VA

Barry R. Davis, M.D.
University of Texas
Houston, TX

Argye Hillis, Ph.D.
Texas A&M University
Waco, TX

Robert B. Nussenblatt, M.D.
National Eye Institute
National Institutes of Health
Bethesda, MD

John P. Phair, M.D.
Northwestern University Medical School
Chicago, IL

Harmon Smith, Ph.D.
Duke University
Durham, NC

Richard Whitley, M.D.
University of Alabama at Birmingham
Birmingham, AL

Last Updated: 10/23/99