Longitudinal Study of Ocular Complications of AIDS (LSOCA)



Status:Recruiting
Conditions:HIV / AIDS, Ocular
Therapuetic Areas:Immunology / Infectious Diseases, Ophthalmology
Healthy:No
Age Range:13 - Any
Updated:5/5/2014
Start Date:August 1999
Contact:Curtis L. Meinert, Ph.D.
Phone:1-410-955-8198

Use our guide to learn which trials are right for you!

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.

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.

Males and females age 13 years and older with diagnosis of AIDS will be eligible
We found this trial at
19
sites
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
1365 Clifton Rd NE # B
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
6565 Fannin Street
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
635 Barnhill Drive
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
9415 Campus Point Drive
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
100 Stein Plaza
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
900 Northwest 17th Street
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
185 S Orange Ave
Newark, New Jersey 07103
(973) 972-4300
UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
?
mi
from
Irvine, CA
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials