Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000836
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
1999-11-02
Brief Title:
A Phase IIIII Trial of Human Anti-CMV Monoclonal Antibody MSL 109 MACRT
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IIIII Trial of Human Anti-CMV Monoclonal Antibody MSL 109 MACRT
Status:
COMPLETED
Status Verified Date:
2012-10
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:
To compare the safety and efficacy of sevirumab MSL 109 Protovir human anti-cytomegalovirus CMV monoclonal antibody plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis
Ganciclovir and foscarnet are used for treatment of CMV retinitis but cause hematologic toxicity and nephrotoxicity respectively Despite continued maintenance therapy with these drugs relapse occurs in 85 percent of patients within 4 months Studies suggest that MSL 109 a human monoclonal antibody when given with either ganciclovir or foscarnet may increase initial response and prolong time to progression in patients with CMV retinitis
Ganciclovir and foscarnet are used for treatment of CMV retinitis but cause hematologic toxicity and nephrotoxicity respectively Despite continued maintenance therapy with these drugs relapse occurs in 85 percent of patients within 4 months Studies suggest that MSL 109 a human monoclonal antibody when given with either ganciclovir or foscarnet may increase initial response and prolong time to progression in patients with CMV retinitis
Detailed Description:
Ganciclovir and foscarnet are used for treatment of CMV retinitis but cause hematologic toxicity and nephrotoxicity respectively Despite continued maintenance therapy with these drugs relapse occurs in 85 percent of patients within 4 months Studies suggest that MSL 109 a human monoclonal antibody when given with either ganciclovir or foscarnet may increase initial response and prolong time to progression in patients with CMV retinitis
Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment
Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment
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?: