A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Status:
Completed
Trial end date:
1998-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)