Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01546818
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2009-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients
Sponsor:
Sumagen
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Observer-blinded, Placebo-controlled Clinical Study to Assess the Safety, Tolerability, and Immune Response of Killed-Whole HIV-1 Vaccine (SAV001-H) Administered Intramuscularly to Chronic HIV-1 Infected Patients Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
Status:
COMPLETED
Status Verified Date:
2013-09
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:
The purpose of this study is to examine the safety, tolerability, and immune response to killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected individuals.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: