Longitudinal Study of Ocular Complications of AIDS (LSOCA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Curtis Meinert, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000168
First received: September 23, 1999
Last updated: June 25, 2014
Last verified: June 2014
  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
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies of Ocular Complications of AIDS (SOCA)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • incidence of CMV retinitis, other ocular complications, mortality. [ Time Frame: Until one year after the enrollment of the last patient. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of sequelae of AIDS-related eye disease (e.g., retinal detachments), incidence of complications of therapy, and long-term outcomes of ocular complications (e.g., visual function, quality of life). [ Time Frame: Until one year after the enrollment of the last patient. ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Laboratory studies will include hematology serum chemistry and lymphocyte subset analysis for all patients. The amount of blood for hematology, serum chemistry, and lymphocyte subset analysis is restricted to no more than a total of 17 mL per draw. Data existing on HIV viral load analysis at the clinic will be collected. If HIV data are not available from medical records within the visit time window, blood should be collected for local HIV viral load determination.


Enrollment: 2392
Study Start Date: August 1998
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of AIDS according to the 1993 CDC diagnostic criteria for AIDS and diagnosed on or after 01 January 2001 will be eligible for enrollment.

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Curtis Meinert, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000168     History of Changes
Other Study ID Numbers: NEI-71, 5U10EY008057
Study First Received: September 23, 1999
Last Updated: June 25, 2014
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 July 23, 2014