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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000836
First received: November 2, 1999
Last updated: October 24, 2012
Last verified: October 2012

November 2, 1999
October 24, 2012
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Complete list of historical versions of study NCT00000836 on ClinicalTrials.gov Archive Site
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A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Sevirumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 1998
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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.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000836
ACTG 294
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP