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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00000168 |
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 | Intervention |
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HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis |
Drug: Highly Active Anti-Retroviral Therapy (HAART) |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Prospective Study |
Study Start Date: | August 1999 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Males and females age 13 years and older with diagnosis of AIDS will be eligible
Contact: Curtis L. Meinert, Ph.D. | 1-410-955-8198 |
United States, California | |
Jules Stein Eye Institute | Recruiting |
Los Angeles, California, United States, 90095-7003 | |
Contact: Gary N. Holland, M.D. 310-825-9508 | |
Shiley Eye Center, 0946 | Recruiting |
La Jolla, California, United States, 92093-0946 | |
Contact: William R. Freeman, M.D. 619-534-3513 | |
Francis I. Proctor Foundation | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Todd Margolis, M.D., Ph.D. 415-476-1921 | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Jennifer Lim, M.D. 323-342-6430 | |
University of California, Irvine | Recruiting |
Irvine, California, United States, 92697-4375 | |
Contact: Baruch D. Kuppermann, M.D., Ph.D. 949-824-6256 | |
United States, Florida | |
Bascom Palmer Eye Institute | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Janet Davis, M.D. 305-326-6377 | |
University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-4799 | |
Contact: Peter R. Pavan, M.D. 813-974-1530 | |
United States, Georgia | |
Emory Eye Clinic | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Daniel F. Martin, M.D. 404-778-4815 | |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: David V. Weinberg, M.D. 312-695-2569 | |
United States, Indiana | |
Division of Infectious Diseases, University of Indiana, Indianapolis | Recruiting |
Indianapolis, Indiana, United States, 46202-2879 | |
Contact: L.Joseph Wheat, M.D. 317-630-6262 | |
United States, Louisiana | |
LSU Eye Center | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Bruce A. Barron, M.D. 504-412-1200 ext 1307 | |
United States, Maryland | |
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21287-9217 | |
Contact: James P. Dunn, M.D. 410-955-2966 | |
United States, New Jersey | |
UMDNJ-New Jersey Medical School | Recruiting |
Newark, New Jersey, United States, 07103-2499 | |
Contact: Ronald Rescigno, M.D. 973-972-9466 | |
United States, New York | |
Department of Ophthalmology | Recruiting |
New York, New York, United States, 10021 | |
Contact: Murk-Hein Heinemann, M.D. 212-746-2483 | |
Department of Ophthalmology | Recruiting |
New York, New York, United States, 10016 | |
Contact: Dorothy Friedberg, M.D. 212-687-0265 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7040 | |
Contact: Travis A. Meredith, M.D. 919-966-5296 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Charles Nichols, M.D. 215-662-6110 | |
United States, Texas | |
Cullen Eye Institute | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Richard Alan Lewis, M.D., M.S. 1-713-798-6100 | |
University of Texas Medical Branch | Recruiting |
Galveston, Texas, United States, 77555-0835 | |
Contact: Helen K. Li, M.D. 409-772-4979 |
Study ID Numbers: | NEI-71 |
Study First Received: | September 23, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000168 |
Health Authority: | United States: Federal Government |
Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Cytomegalovirus retinitis Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
RNA Virus Infections Pathologic Processes Disease Slow Virus Diseases Eye Infections, Viral |
Immune System Diseases Syndrome Lentivirus Infections Infection |