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NCT00002016 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
A Phase 1 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00002016: Completed Phase 1 study, sponsored by Sandoz.
NCT00002016 is a Phase 1 study that has completed, run by Sandoz. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002016, a Phase 1 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.
Interventions
- DRUG Sevirumab
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
What the finished NCT00002016 record still lists
NCT00002016 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.
NCT00002016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00002016 about?
NCT00002016 is a clinical study titled "A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis". To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV r...
What is the current status of trial NCT00002016?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00002016?
The interventions under investigation include: Sevirumab (DRUG).
Who is sponsoring clinical trial NCT00002016?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.