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Clinical Trials/NCT00002268
NCT00002268
Completed
Phase 1

A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria

Sandoz2 sites in 1 countryAugust 31, 2001
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ConditionsCytomegalovirus InfectionsHIV Infections
DrugsSevirumab

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cytomegalovirus Infections
Sponsor
Sandoz
Locations
2
Status
Completed
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12 doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture proven evidence of CMV viremia and/or viruria. Sandoglobulin will be employed as a comparative control.

Registry
clinicaltrials.gov
Start Date
August 31, 2001
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sandoz

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

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