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Longitudinal Study of Ocular Complications of AIDS (LSOCA) Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Longitudinal Study of Ocular Complications of AIDS (LSOCA) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Longitudinal Study of Ocular Complications of AIDS (LSOCA) Clinical research trials and Longitudinal Study of Ocular Complications of AIDS (LSOCA) medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Longitudinal Study of Ocular Complications of AIDS (LSOCA). Longitudinal Study of Ocular Complications of AIDS (LSOCA) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Longitudinal Study of Ocular Complications of AIDS (LSOCA) clinical trial. Participants frequently get the best healthcare available for their Longitudinal Study of Ocular Complications of AIDS (LSOCA) condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Longitudinal Study of Ocular Complications of AIDS (LSOCA)  Longitudinal Study of Ocular Complications of AIDS (LSOCA)
Longitudinal Study of Ocular Complications of AIDS (LSOCA)
For Condition: HIV Infections,Acquired Immunodeficiency Syndrome,Cytomegalovirus Retinitis
Status: Recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History, Longitudinal, Prospective Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Males and females age 13 years and older with diagnosis of AIDS will be eligible
Total Enrollment:
Location and Contact Information:
University of California, Irvine *Recruiting*
Irvine, California, 92697-4375
United States
Recruiting Baruch Kuppermann 949-824-6256
University of Southern California *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Jennifer Lim 323-342-6430
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0835
United States
Recruiting Helen Li 409-772-4979
Bascom Palmer Eye Institute *Recruiting*
Miami, Florida, 33136
United States
Recruiting Janet Davis 305-326-6377
Jules Stein Eye Institute *Recruiting*
Los Angeles, California, 90095-7003
United States
Recruiting Gary Holland 310-825-9508
Francis I. Proctor Foundation *Recruiting*
San Francisco, California, 94143
United States
Recruiting Todd Margolis 415-476-1921
Department of Ophthalmology *Recruiting*
New York City, New York, 10021
United States
Recruiting Murk-Hein Heinemann 212-746-2483
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting David Weinberg 312-695-2569
University of North Carolina at Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7040
United States
Recruiting Travis Meredith 919-966-5296
LSU Eye Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Bruce Barron 504-412-1200
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine *Recruiting*
Baltimore, Maryland, 21287-9217
United States
Recruiting James Dunn 410-955-2966
Shiley Eye Center, 0946 *Recruiting*
La Jolla, California, 92093-0946
United States
Recruiting William Freeman 619-534-3513
Division of Infectious Diseases, University of Indiana, Indianapolis *Recruiting*
Indianapolis, Indiana, 46202-2879
United States
Recruiting L.Joseph Wheat 317-630-6262
Hospital of the University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Charles Nichols 215-662-6110
UMDNJ-New Jersey Medical School *Recruiting*
Newark, New Jersey, 07103-2499
United States
Recruiting Ronald Rescigno 973-972-9466
Cullen Eye Institute *Recruiting*
Houston, Texas, 77030
United States
Recruiting Richard Lewis 1-713-798-6100
University of South Florida *Recruiting*
Tampa, Florida, 33612-4799
United States
Recruiting Peter Pavan 813-974-1530
Emory Eye Clinic *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Daniel Martin 404-778-4815
Department of Ophthalmology *Recruiting*
New York City, New York, 10016
United States
Recruiting Dorothy Friedberg 212-687-0265
Additional Information:
Study ID Numbers: NEI-71;
Study Start Date: August 1999
Record last reviewed: October 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000168
Other Acquired Immunodeficiency Syndrome Studies:
1. Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis
2. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
3. A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
4. A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
5. The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
Related Studies:
Other Acquired Immunodeficiency Syndrome Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Longitudinal Study of Ocular Complications of AIDS (LSOCA)
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