Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091884
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-09-17
Brief Title:
Efficacy of Elevated CD4 Counts on CMV 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:
2005-04
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:
Some patients with HIVAIDS suffer from a dangerous viral infection of the retina and other organs called cytomegalovirus infection CMV The medications currently used to treat CMV all have serious side effects AIDS patients are prone to this infection because their immune system produces a lower number of CD4T lymphocytes the type of blood cells that fight viral infections
Some new HIV medications strengthen the immune system This study will investigate the possibility that CMV patients on these HIV medications can develop immune systems strong enough to fight CMV without CMV medication The study will enroll a maximum of 15 adult HIVAIDS patients who have a CD4T cell count over 150 cellsmicroliter and who have inactive CMV retinitis that is not immediately sight threatening It is expected to last approximately 2 years
Each prospective participant will have a physical examination and complete eye examination including retina photographs with the eye examination and retina photographs repeated 2 weeks later If there is no evidence of active CMV retinitis the participant will be enrolled in the study and CMV medication will be stopped The participant will have physical and eye examinations every 2 weeks for the first 3 months of the study and every 3 weeks for the next 3 months After 6 months the frequency of the examinations will be 2-8 weeks depending on the participants CD4 count After one year a participant with a CD4 count remaining over 150 cellsmicroliter may return to the care of a local ophthalmologist with HIVCMV experience revisiting the clinical center every 6 months The participants CMV medication will be restarted when CMV retinitis becomes active which will terminate participation in the study
Some new HIV medications strengthen the immune system This study will investigate the possibility that CMV patients on these HIV medications can develop immune systems strong enough to fight CMV without CMV medication The study will enroll a maximum of 15 adult HIVAIDS patients who have a CD4T cell count over 150 cellsmicroliter and who have inactive CMV retinitis that is not immediately sight threatening It is expected to last approximately 2 years
Each prospective participant will have a physical examination and complete eye examination including retina photographs with the eye examination and retina photographs repeated 2 weeks later If there is no evidence of active CMV retinitis the participant will be enrolled in the study and CMV medication will be stopped The participant will have physical and eye examinations every 2 weeks for the first 3 months of the study and every 3 weeks for the next 3 months After 6 months the frequency of the examinations will be 2-8 weeks depending on the participants CD4 count After one year a participant with a CD4 count remaining over 150 cellsmicroliter may return to the care of a local ophthalmologist with HIVCMV experience revisiting the clinical center every 6 months The participants CMV medication will be restarted when CMV retinitis becomes active which will terminate participation in the study
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 |
|---|---|---|---|
| 04-EI-0223 | None | None | None |