A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

Phase 2

Completed

• Conditions: Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00000836
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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.

Study Timeline

• Study Completion: 1998-08
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

UCSD - Shiley Eye Ctr / SOCA; 🇺🇸 La Jolla, California, United States

UCLA - Jules Stein Eye Institute / SOCA; 🇺🇸 Los Angeles, California, United States

UCSF - San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Northwestern Univ / SOCA; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Hosp / SOCA; 🇺🇸 Baltimore, Maryland, United States

New York Univ Med Ctr / SOCA; 🇺🇸 New York, New York, United States