Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000168
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
1999-09-23
Brief Title:
Longitudinal Study of Ocular Complications of AIDS LSOCA
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Studies of Ocular Complications of AIDS SOCA
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LSOCA
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
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
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 andor 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 7825 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 2000 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
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 7825 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 2000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10EY008057 | NIH | None | httpsreporternihgovquickSearch5U10EY008057 |