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NCT00002268 · ClinicalTrials.gov registry record · 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
A Phase 1 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00002268 is a Phase 1 study that has completed, run by Sandoz.
The verdict
NCT00002268, a Phase 1 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study 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.
Interventions
- DRUG Sevirumab
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002268
The ClinicalTrials.gov registry entry for NCT00002268 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sevirumab is the first listed.
NCT00002268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002268 about?
NCT00002268 is a clinical study titled "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". 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 eithe...
What is the current status of trial NCT00002268?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00002268?
The interventions under investigation include: Sevirumab (DRUG).
Who is sponsoring clinical trial NCT00002268?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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