A Phase II/III Trial of Human Anti-CMV Monoclonal Antibod... | NCT00000836

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

NCT00000836

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Last Update Posted

Oct 25, 2012Estimated

Enrollment

300

Phase

Phase 2

Conditions

Cytomegalovirus Retinitis
HIV Infections

Interventions

Sevirumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Aug 1998Actual

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2012

Last Update Posted Date

Oct 25, 2012Estimated

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
Sevirumab	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
UCSD - Shiley Eye Ctr / SOCA		La Jolla	California	920930946	United States
UCLA - Jules Stein Eye Institute / SOCA

Condition Browse Module

MeSH Terms

ID	Term
D017726	Cytomegalovirus Retinitis
D015658	HIV Infections
D017088	AIDS-Related Opportunistic Infections
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015828	Eye Infections, Viral
D015817	Eye Infections
D007239	Infections
D003586	Cytomegalovirus Infections

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Not provided

Browse Branches

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