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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: Completed Phase 1 study, sponsored by Sandoz.
NCT00002268 is a Phase 1 study that has completed, run by Sandoz. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00002268 record still lists
NCT00002268 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which Sevirumab is the first listed.
NCT00002268 does not publish any study locations in the registry export this page uses.
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.