Search / Trial NCT00000836

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Aids Related Opportunistic Infections Acquired Immunodeficiency Syndrome Antibodies, Monoclonal Cytomegalovirus 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.

Gender

All

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.

Attachments

readout_NCT00000836_2024-07-14.pdf

4.5 MB

NCT00000836_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Francisco, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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