Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223080
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2005-09-13
Brief Title:
HIV Vaccine Trial in Thai Adults
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV vCP1521 Priming With VaxGen gp120 BE AIDSVAX BE Boosting in HIV-uninfected Thai Adults
Status:
COMPLETED
Status Verified Date:
2019-04
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:
The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV vCP1521 boosted by AIDSVAX gp120 BE prevent HIV infection in healthy Thai volunteers
Detailed Description:
A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic In this phase III efficacy trial a prime-boost vaccine strategy is evaluated for prevention of infection and amelioration of disease course ALVAC-HIV vCP1521 from sanofi pasteur is given as the prime vaccine at months 0 1 3 and 6 AIDSVAX gp120 BE from VaxGen is given as the boost at months 3 and 6 This regimen will be given to 8000 adult Thai subjects while another 8000 will be given placebos in a double-blinded randomized manner Following the completion of each subjects immunization phase heshe will be followed for 3 years with clinic visits every 6 months with HIV testing pre- and post-test counseling Subjects who become HIV infected will be counseled referred to HIV treatment facilities for management according to national guidelines and offered enrollment in a protocol for extended follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSRRB A-11048 | OTHER | USAMRMC HSRRB | None |