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Longitudinal Study of Ocular Complications of AIDS (LSOCA) (LSOCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000168
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : June 12, 2015
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Curtis Meinert, Johns Hopkins Bloomberg School of Public Health

Study Description
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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
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
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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 : August 1998
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. incidence of CMV retinitis, other ocular complications, mortality. [ Time Frame: Until one year after the enrollment of the last patient. ]

Secondary Outcome Measures :
  1. 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. ]

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.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000168


Locations
Show Show 19 study locations
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Eye Institute (NEI)
Investigators
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Study Chair: Doug A Jabs, MD Icahn School of Medicine at Mount Sinai
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Curtis Meinert, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000168    
Other Study ID Numbers: NEI-71
5U10EY008057 ( U.S. NIH Grant/Contract )
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Immunologic Deficiency Syndromes
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Genital Diseases
Urogenital Diseases
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections