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

Completed · Phase 2

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000836

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Expected to finish

1998-08-01

Last updated by the study team

2012-10-25

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication: Required:
• Primary CMV treatment.
• Patients must have:
• AIDS.
• Active CMV retinitis.
• At least one photographable lesion of one-quarter or more optic disc area in size.
• Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109.
• Visual acuity in at least one eye of 3 or more letters on Early Treatment Diabetic Retinopathy Study ( ETDRS ) chart at 1 meter distance ( Snellen equivalent 5/200 ). Note:
• Exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Retinal detachment not scheduled for surgical repair.
• Media opacity that precludes visualization of the fundus.
• Active medical problems sufficient to hinder study compliance.
• Concurrent Medication:
• Excluded:
• IVIG.
• CMV immune globulin ( CMVIG ).
• Interferon alpha.
• Interferon gamma.
• Interleukin-2 ( IL-2 ).
• Drug or alcohol abuse sufficient to hinder study compliance.

Where it is running

• 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

Full record on ClinicalTrials.gov

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