Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002268
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Phase III 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 andor Viruria
Sponsor:
Sandoz
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Phase III 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 andor Viruria
Status:
COMPLETED
Status Verified Date:
1991-12
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 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 andor viruria Sandoglobulin will be employed as a comparative control
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 B102 | None | None | None |