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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000836
First Posted: August 31, 2001
Last Update Posted: October 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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 Intervention Phase
Cytomegalovirus Retinitis HIV Infections Drug: Sevirumab Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
Study Completion Date: August 1998
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000836


Locations
United States, California
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States, 920930946
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States, 900957003
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94143
United States, Illinois
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, United States, 212879217
United States, New York
New York Univ Med Ctr / SOCA
New York, New York, United States, 10016
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

ClinicalTrials.gov Identifier: NCT00000836     History of Changes
Other Study ID Numbers: ACTG 294
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: October 25, 2012
Last Verified: October 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
Antibodies, Monoclonal
Cytomegalovirus Retinitis

Additional relevant MeSH terms:
HIV Infections
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs