Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000135
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
1999-09-23
Brief Title:
Studies of the Ocular Complications of AIDS SOCA--Monoclonal Antibody CMV Retinitis Trial MACRT
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Monoclonal Antibody CMV Retinitis Trial MACRT
Status:
COMPLETED
Status Verified Date:
2015-07
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:
MACRT
Brief Summary:
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody MSL-109 as adjunct therapy for controlling CMV retinitis
Detailed Description:
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS Untreated CMV retinitis is a progressive disorder the end result of which is total retinal destruction and blindness As of September 1996 drugs approved by the United States Food and Drug Administration FDA for the treatment of CMV retinitis were ganciclovir Cytovene foscarnet Foscavir and cidofovir Vistide All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment induction to control the infection followed by long-term lower dose treatment maintenance to prevent relapse Ganciclovir is available in both intravenous and oral formulations foscarnet only in an intravenous formulation and cidofovir is given by intermittent intravenous administration A surgically implanted intraocular sustained-release ganciclovir device Vitrasert is also approved by the FDA for the treatment of CMV retinitis
Despite the use of continuous maintenance therapy given enough time all patients with CMV retinitis on systemically administered drugs relapse Preliminary studies suggested that the anti-CMV monoclonal antibody MSL-109 when administered in conjunction with ganciclovir markedly prolonged the time to relapse Therefore a randomized controlled clinical trial evaluating MSL-109 as adjunct therapy was conducted
The MACRT was a randomized placebo-controlled multicenter clinical trial evaluating the efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis Patients with CMV retinitis both those newly diagnosed and those suffering a relapse with active retinitis were eligible Primary therapy eg ganciclovir foscarnet etc was determined by the treating local physician The patients enrolled in the trial were randomized to either MSL-109 or placebo administered as a rapid intravenous infusion every 2 weeks Outcomes included survival retinitis progression change in amount of retinal area involved by CMV loss of visual function acuity and field and morbidity
Despite the use of continuous maintenance therapy given enough time all patients with CMV retinitis on systemically administered drugs relapse Preliminary studies suggested that the anti-CMV monoclonal antibody MSL-109 when administered in conjunction with ganciclovir markedly prolonged the time to relapse Therefore a randomized controlled clinical trial evaluating MSL-109 as adjunct therapy was conducted
The MACRT was a randomized placebo-controlled multicenter clinical trial evaluating the efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis Patients with CMV retinitis both those newly diagnosed and those suffering a relapse with active retinitis were eligible Primary therapy eg ganciclovir foscarnet etc was determined by the treating local physician The patients enrolled in the trial were randomized to either MSL-109 or placebo administered as a rapid intravenous infusion every 2 weeks Outcomes included survival retinitis progression change in amount of retinal area involved by CMV loss of visual function acuity and field and morbidity
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