Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-02 @ 9:26 AM
Study NCT ID:
NCT01571466
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
Sponsor:
Hospital Clinic of Barcelona
Organization:
Study Overview
Official Title:
A Double-blind Phase I Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
Status:
COMPLETED
Status Verified Date:
2015-03
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:
2009-016578-34
Brief Summary:
30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the study site for one hour following vaccination. At week 24 they will stop their HAART until the end of the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: