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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000836
• Other study ID #: ACTG 294
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: October 24, 2012
• Est. completion date: August 1998

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 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.

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Sevirumab

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp / SOCA	Baltimore	Maryland
United States	Northwestern Univ / SOCA	Chicago	Illinois
United States	UCSD - Shiley Eye Ctr / SOCA	La Jolla	California
United States	UCLA - Jules Stein Eye Institute / SOCA	Los Angeles	California
United States	New York Univ Med Ctr / SOCA	New York	New York
United States	UCSF - San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,