Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002016
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase III 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
Sponsor:
Sandoz
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III 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
Status:
COMPLETED
Status Verified Date:
1993-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Study No B103 | None | None | None |