Longitudinal Study of Ocular Complications of AIDS (LSOCA)

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.

Clinical Centers

California
Gary N. Holland, M.D.
Jules Stein Eye Institute
University of California, Los Angeles
100 Stein Plaza
Los Angeles, CA 90095-7003
Telephone: (310) 825-9508

William R. Freeman, M.D.
Shiley Eye Center, 0946
University of California, San Diego
9400 Gilman Drive
La Jolla, CA 92093-0946
Telephone: (619) 534-3513

Todd Margolis, M.D., Ph.D.
Francis I. Proctor Foundation
University of California, San Francisco
Box 0730, Room K-301
95 Kirkham Street
San Francisco, CA 94143
Telephone: (415) 476-1921

Jennifer Lim, M.D.
University of Southern California
Doheny Eye Institute
1450 San Pablo St., Suite 4703
Los Angeles, CA 90033
Telephone: (323) 342-6430

Baruch D. Kuppermann, M.D., Ph.D.
University of California, Irvine
Department of Ophthalmology
118 Med Surge 1
Irvine, CA 92697-4375
Telephone: (949) 824-6256

Florida
Janet Davis, M.D.
Bascom Palmer Eye Institute
University of Miami
900 N.W. 17th Street
Miami, FL 33136
Telephone: (305) 326-6377

Peter R. Pavan, M.D.
University of South Florida
MDC Box 21
12901 Bruce B. Downs Boulevard
Tampa, FL 33612-4799
Telephone: (813) 974-1530

Georgia
Daniel F. Martin, M.D.
Emory Eye Clinic
1365B Clifton Road, N.E.
Atlanta, GA 30322
Telephone: (404) 778-4815

Illinois
David V. Weinberg, M.D.
Northwestern University
Department of Ophthalmology
675 N. St. Clair Street
Galter Pavilion, 15th Floor
Chicago, IL 60611
Telephone: (312) 695-2569

Indiana
L. Joseph Wheat, M.D.
Division of Infectious Diseases
University of Indiana, Indianapolis
1001 West Tenth Street, 430-OPW
Indianapolis, IN 46202-2879
Telephone: (317) 630-6262

Louisiana
Bruce A. Barron, M.D.
LSU Eye Center
Louisiana State University Medical Center
2020 Gravier Street, Suite B
New Orleans, LA 70112
Telephone: (504) 412-1200 x1307

Maryland
James P. Dunn, M.D.
The Wilmer Ophthalmological Institute
The Johns Hopkins University School of Medicine
Maumenee 119
The Johns Hopkins Hospital
600 North Wolfe Street
Baltimore, MD 21287-9217
Telephone: (410) 955-2966

New Jersey
Ronald Rescigno, M.D.
UMDNJ-New Jersey Medical School
Department of Ophthalmology, DOC 6th floor
90 Bergen Street
Newark, NJ 07103-2499
Telephone: (973) 972-9466

New York
Murk-Hein Heinemann, M.D.
Department of Ophthalmology
New York Hospital-Cornell Medical Center
525 East 68th Street
New York, NY 10021
Telephone: (212) 746-2483

Dorothy Friedberg, M.D.
Department of Ophthalmology
New York University Medical Center
310 Lexington Avenue
New York, NY 10016
Telephone: (212) 687-0265

North Carolina
David Wohl, M.D.
University of North Carolina @ Chapel Hill
CB 7215, 514 Burnett-Womack Building
Chapel Hill, NC 27599-7215
Telephone: (919) 966-3578

Pennsylvania
Charles Nichols, M.D.
Hospital of the University of Pennsylvania
Department of Ophthalmology
3400 Spruce Street, 2 E. Gates Building
Philadelphia, PA 19104
Telephone: (215) 662-6110

Texas
Richard Alan Lewis, M.D., M.S.
Cullen Eye Institute
Baylor College of Medicine
6501 Fannin Street, NC-200
Houston, TX 77030
Telephone: (713) 798-6100

Helen K. Li, M.D.
University of Texas Medical Branch
301 University Boulevard
Galveston, TX 77555-0835
Telephone: (409) 772-4979

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

This page was last modified in October 2008

U. S. Department of Health and Human Services

National Institutes of Health