Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001611
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Immune Activity Against CVM Retinitis
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Efficacy of Elevated CD4 Cell Counts on CMV Retinitis
Status:
COMPLETED
Status Verified Date:
2004-04
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:
None
Brief Summary:
This study will investigate whether medication for cytomegalovirus CMV retinitis-a viral infection of the eye-can safely be stopped in HIV-infected patients whose immune function has improved from anti-HIV therapy Medicines taken to fight CMV infection ganciclovir foscarnet and cidofovir can cause serious side effects such as low blood counts and kidney damage Stopping these medications may therefore be beneficial
Patients with HIV infection who develop CVM retinitis usually have very low levels of infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of blood New anti-HIV medications have been able to raise CD4 levels and improve immune function in many patients This study will see if patients with CD4 levels above 150 cells per microliter can fight CVM retinitis without additional anti-CVM drugs
HIV-infected patients with CVM retinitis will have a physical examination and complete eye examination These tests will be repeated after 2 weeks If there is no evidence that the CMV infection has progressed and if it is in a location that is not immediately sight-threatening anti-CMV medications will be stopped Patients will be examined every 2 weeks for 3 months and then every 3 weeks for the next 3 months Patients whose CD4 count has remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM infection becomes active again At that time anti-CVM medicines will be re-started Patients will also have blood and urine samples taken to test for levels of HIV and CMV in the blood and urine and will be interviewed about their vision and how it affects daily activities
Patients with HIV infection who develop CVM retinitis usually have very low levels of infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of blood New anti-HIV medications have been able to raise CD4 levels and improve immune function in many patients This study will see if patients with CD4 levels above 150 cells per microliter can fight CVM retinitis without additional anti-CVM drugs
HIV-infected patients with CVM retinitis will have a physical examination and complete eye examination These tests will be repeated after 2 weeks If there is no evidence that the CMV infection has progressed and if it is in a location that is not immediately sight-threatening anti-CMV medications will be stopped Patients will be examined every 2 weeks for 3 months and then every 3 weeks for the next 3 months Patients whose CD4 count has remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM infection becomes active again At that time anti-CVM medicines will be re-started Patients will also have blood and urine samples taken to test for levels of HIV and CMV in the blood and urine and will be interviewed about their vision and how it affects daily activities
Detailed Description:
This is a clinical trial to determine whether elevated CD4 counts resulting from medications against human immunodeficiency virus HIV are effective in controlling cytomegalovirus CMV retinitis Patients with non-progressive retinal disease consistent with inactive CMV retinitis in a location that is not immediately sight threatening who are currently receiving systemic maintenance therapy with ganciclovir foscarnet or cidofovir and who have a total CD4 cell count greater than 150 cells per microliter will have their anti-CMV therapy discontinued Patients will then be closely followed for progression of their CMV retinitis The primary endpoint of the study will be progression of CMV retinitis Secondary endpoints will include the occurrence of extraocular CMV disease morbidity mortality virologic data and HIV burden
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 |
|---|---|---|---|
| 97-EI-0081 | None | None | None |