Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332930
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2006-06-01
Brief Title:
ITV Extension Study
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
An Extension Study to Protocol VIR-NCHR-01 to Assess the Antiretrovirological Properties of a Therapeutic HIV Vaccine Candidate Based on Recombinant Fowlpox Virus rFPV ITV Extension Study
Status:
COMPLETED
Status Verified Date:
2006-06
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 objective of this phase III therapeutic human immunodeficiency virus HIV vaccine candidate study is to provide proof of concept for a HIV antigen delivery system in terms of safety virological effects and selected immune responses in HIV infected individuals after cessation of antiretroviral combination therapy ART
Detailed Description:
A multi-centre double-blind placebo-controlled 20-week parallel group extension study to the VIR-NCHR-01 protocol ITV study The purpose of the extension study is to assess the safety and virological effects of a therapeutic HIV vaccine strategy in HIV-1 infected adults currently enrolled in the ITV study after cessation of antiretroviral therapy Two active candidate vaccines will be studied in this trial The active treatment arms will receive recombinant fowlpoxvirus rFPV expressing HIV gag-pol antigens or HIV gag-pol antigens and interferon-gamma IFN-y in diluent Vaccines will be delivered by intramuscular injection
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