Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002441
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
Sponsor:
VaxGen
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Trial to Determine the Efficacy of Bivalent AIDSVAX BB Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America
Status:
COMPLETED
Status Verified Date:
2000-01
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 see if an HIV vaccine AIDSVAX BB can protect adults who are at risk from becoming infected with HIV Patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep HIV levels viral load low
Detailed Description:
Volunteers receive 7 blinded intramuscular vaccinations at Months 0 1 6 12 18 24 30 containing either the AIDSVAX BB vaccine or a placebo aluminum adjuvant only Volunteers are randomized in a 2 to 1 vaccine-to-placebo ratio HIV-uninfected persons are followed for a total of 16 visits beginning at screening and continuing until Month 36 Patients who become HIV infected during study are followed every 4 months for at least 24 months
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?: