Longitudinal Study of Ocular Complications of AIDS (LSOCA)

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT00000168

Collaborator

National Eye Institute (NEI) (NIH)

2,392

Enrollment

Locations

180

Duration (Months)

125.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

2392 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Studies of Ocular Complications of AIDS (SOCA)

Study Start Date :

Aug 1, 1998

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Outcome Measures

Primary Outcome Measures

incidence of CMV retinitis, other ocular complications, mortality. [Until one year after the enrollment of the last patient.]

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). [Until one year after the enrollment of the last patient.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

A diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention (CDC) definition (with or without clinical symptoms of CMV retinitis or other ocular complications of AIDS)
Age 13 years or older
Signed consent statement
Patients with newly diagnosed (within 45 days of enrollment) Ocular Opportunistic Infections (OOIs)
Patients without a newly diagnosed Ocular Opportunistic Infection (OOI) diagnosed with AIDS after 1 Jan 2001

Exclusion criteria:

none.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92697-4375
2	Shiley Eye Center, 0946	La Jolla	California	United States	92093-0946
3	University of Southern California	Los Angeles	California	United States	90033
4	Jules Stein Eye Institute	Los Angeles	California	United States	90095-7003
5	Francis I. Proctor Foundation	San Francisco	California	United States	94143
6	Bascom Palmer Eye Institute	Miami	Florida	United States	33136
7	University of South Florida	Tampa	Florida	United States	33612-4799
8	Emory Eye Clinic	Atlanta	Georgia	United States	30322
9	Northwestern University	Chicago	Illinois	United States	60611
10	Division of Infectious Diseases, University of Indiana, Indianapolis	Indianapolis	Indiana	United States	46202-2879
11	LSU Eye Center	New Orleans	Louisiana	United States	70112
12	The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21287-9217
13	UMDNJ-New Jersey Medical School	Newark	New Jersey	United States	07103-2499
14	Department of Ophthalmology	New York	New York	United States	10016
15	Department of Ophthalmology	New York	New York	United States	10021
16	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7040
17	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
18	University of Texas Medical Branch	Galveston	Texas	United States	77555-0835
19	Cullen Eye Institute	Houston	Texas	United States	77030