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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000836

Collaborator

(none)

300

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Sevirumab	Phase 2

Detailed Description

Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Aug 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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

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.

Exclusion Criteria

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD - Shiley Eye Ctr / SOCA	La Jolla	California	United States	920930946
2	UCLA - Jules Stein Eye Institute / SOCA	Los Angeles	California	United States	900957003
3	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94143
4	Northwestern Univ / SOCA	Chicago	Illinois	United States	60611
5	Johns Hopkins Hosp / SOCA	Baltimore	Maryland	United States	212879217
6	New York Univ Med Ctr / SOCA	New York	New York	United States	10016