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

September 23, 1999
June 25, 2014
August 1998
August 2013   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00000168 on ClinicalTrials.gov Archive Site
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 ]
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Longitudinal Study of Ocular Complications of AIDS (LSOCA)
Studies of Ocular Complications of AIDS (SOCA)

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Cytomegalovirus Retinitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2392
August 2013
August 2013   (final data collection date for primary outcome measure)

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

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000168
NEI-71, 5U10EY008057
Yes
Curtis Meinert, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
National Eye Institute (NEI)
Study Chair: Doug A Jabs, MD Mount Sinai School of Medicine
Johns Hopkins Bloomberg School of Public Health
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP