search
Back to results

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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sevirumab
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Antibodies, Monoclonal, Cytomegalovirus Retinitis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • UCSD - Shiley Eye Ctr / SOCA
  • UCLA - Jules Stein Eye Institute / SOCA
  • UCSF - San Francisco Gen Hosp
  • Northwestern Univ / SOCA
  • Johns Hopkins Hosp / SOCA
  • New York Univ Med Ctr / SOCA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 24, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000836
Brief Title
A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Official Title
A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Antibodies, Monoclonal, Cytomegalovirus Retinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sevirumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UCSD - Shiley Eye Ctr / SOCA
City
La Jolla
State/Province
California
ZIP/Postal Code
920930946
Country
United States
Facility Name
UCLA - Jules Stein Eye Institute / SOCA
City
Los Angeles
State/Province
California
ZIP/Postal Code
900957003
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Northwestern Univ / SOCA
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hosp / SOCA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212879217
Country
United States
Facility Name
New York Univ Med Ctr / SOCA
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs