Longitudinal Study of Ocular Complications of AIDS (LSOCA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 1999 by National Eye Institute (NEI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000168
First received: September 23, 1999
Last updated: June 23, 2005
Last verified: October 1999
  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.


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

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Study Start Date: August 1999
Detailed 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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000168

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

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697-4375
Contact: Baruch D. Kuppermann, M.D., Ph.D.    949-824-6256      
Shiley Eye Center, 0946 Recruiting
La Jolla, California, United States, 92093-0946
Contact: William R. Freeman, M.D.    619-534-3513      
Jules Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095-7003
Contact: Gary N. Holland, M.D.    310-825-9508      
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Jennifer Lim, M.D.    323-342-6430      
Francis I. Proctor Foundation Recruiting
San Francisco, California, United States, 94143
Contact: Todd Margolis, M.D., Ph.D.    415-476-1921      
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
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0835
Contact: Helen K. Li, M.D.    409-772-4979      
Cullen Eye Institute Recruiting
Houston, Texas, United States, 77030
Contact: Richard Alan Lewis, M.D., M.S.    1-713-798-6100      
Sponsors and Collaborators
  More Information

No publications provided by National Eye Institute (NEI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000168     History of Changes
Other Study ID Numbers: NEI-71
Study First Received: September 23, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections

ClinicalTrials.gov processed this record on April 17, 2014