Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002363
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Sponsor:
Columbia Research Laboratories
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Study of the Safety and Effects of Two Doses of SPC3 Administered Daily Intravenously in HIV-1 Seropositive Patients
Status:
COMPLETED
Status Verified Date:
1999-04
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 assess the effects of two doses of synthetic peptide construction 3 SPC3 on HIV-1 plasma levels as measured by RNA PCR Amplicor and on lymphocyte subsets in patients with initial viral load above 10000 copiesml To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes
Detailed Description:
The first five patients receive SPC3 daily for 3 weeks If that dose is tolerated the dose is increased and given to the next 5 patients for 3 weeks The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels Patients are followed through day 28
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 |
|---|---|---|---|
| SPC3-US1 | None | None | None |