Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000905
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus CMV Retinitis After Effective Anti-HIV Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Discontinuation of Maintenance Therapy for Cytomegalovirus CMV Retinitis After Immune Reconstitution by Potent Antiretroviral Therapy Safety Virology and Immunology Profiles
Status:
COMPLETED
Status Verified Date:
2003-06
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:
None
Brief Summary:
The purpose of this study is to see if it is safe to stop maintenance therapy in HIV-positive patients with treated and healed CMV retinitis eye disease who have responded well to anti-HIV antiretroviral therapy
The current therapies available to treat CMV retinitis are long-term therapies However it may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs
The current therapies available to treat CMV retinitis are long-term therapies However it may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs
Detailed Description:
This study proposes to assess the hypothesis that in HIV-infected patients with treated and healed CMV retinitis an increase in CD4 T-cells after initiation of potent antiretroviral therapy is either directly related to or a marker of immunologic protection for CMV retinitis and is associated with a recovery in specific proliferation responses to CMV antigens
In this study 100 patients AS PER AMENDMENT 7299 50 patients with treated and healed non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis Patients are studied in 2 groups Patients enrolled in Group 1 have CD4 counts greater than 100 cellsmm3 Group 2 patients have CD4 counts of 50-100 cellsmm3 and a minimum of a 2 log10 decrease in plasma HIV-1 RNA level or plasma HIV-1 RNA levels below the limit of detection while receiving potent antiretroviral therapy for at least 8 weeks prior to entry AS PER AMENDMENT 7299 Group 2 has been withdrawn An additional 25 patients who meet eligibility requirements but who choose to continue to receive maintenance therapy may also participate All patients are followed to evaluate the relationship between reactivation or progression of CMV disease and changes in CMV DNA HIV-1 RNA and CD4 cell counts Patients are seen at Weeks 2 4 6 and 8 and every 4 weeks until study closure or for 12 months after the last subject is enrolled AS PER AMENDMENT 122498 Patients with confirmed moderate to severe immune recovery vitritis should receive a 3-week course of systemic steroids oral prednisone recommended Moderate immune recovery vitritis is defined as symptomatic decrease in visual acuity of 2 or more Snellen lines along with in the absence of active CMV disease either 2 or greater vitreous haze as defined by Nussenblatt et al or cystoid macular edema AS PER AMENDMENT 7299 During the course of the study in patients with confirmed cystoid macular edema and a concomitant reduction in visual activity below 2040 both attributable to immune recovery vitritisuveitis only a 21-day course of oral prednisone is recommended This initial course of steroids helps to determine whether there is an improvement in vision or a decrease in macular edema Long-term management of immune recovery vitritisuveitis may include intraocular injection of steroids Ophthalmoscopic examinations and laboratory tests are performed as per protocol
In this study 100 patients AS PER AMENDMENT 7299 50 patients with treated and healed non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis Patients are studied in 2 groups Patients enrolled in Group 1 have CD4 counts greater than 100 cellsmm3 Group 2 patients have CD4 counts of 50-100 cellsmm3 and a minimum of a 2 log10 decrease in plasma HIV-1 RNA level or plasma HIV-1 RNA levels below the limit of detection while receiving potent antiretroviral therapy for at least 8 weeks prior to entry AS PER AMENDMENT 7299 Group 2 has been withdrawn An additional 25 patients who meet eligibility requirements but who choose to continue to receive maintenance therapy may also participate All patients are followed to evaluate the relationship between reactivation or progression of CMV disease and changes in CMV DNA HIV-1 RNA and CD4 cell counts Patients are seen at Weeks 2 4 6 and 8 and every 4 weeks until study closure or for 12 months after the last subject is enrolled AS PER AMENDMENT 122498 Patients with confirmed moderate to severe immune recovery vitritis should receive a 3-week course of systemic steroids oral prednisone recommended Moderate immune recovery vitritis is defined as symptomatic decrease in visual acuity of 2 or more Snellen lines along with in the absence of active CMV disease either 2 or greater vitreous haze as defined by Nussenblatt et al or cystoid macular edema AS PER AMENDMENT 7299 During the course of the study in patients with confirmed cystoid macular edema and a concomitant reduction in visual activity below 2040 both attributable to immune recovery vitritisuveitis only a 21-day course of oral prednisone is recommended This initial course of steroids helps to determine whether there is an improvement in vision or a decrease in macular edema Long-term management of immune recovery vitritisuveitis may include intraocular injection of steroids Ophthalmoscopic examinations and laboratory tests are performed as per protocol
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: