Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095576
Status:
TERMINATED
Last Update Posted:
2015-10-06
First Post:
2004-11-05
Brief Title:
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study V520-023
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 GagPolNef Vaccine MRK AD5 HIV-1 GagPolNef in Adults at High Risk of HIV-1 Infection
Status:
TERMINATED
Status Verified Date:
2015-10
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:
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus HIV vaccine Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected
On September 18 2007 the Protocol V520-023 DSMB Data Safety Monitoring Board reviewed data from a planned interim analysis These data demonstrated that the investigational vaccine candidate was not effective and all vaccinations in the study were halted
Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective
On September 18 2007 the Protocol V520-023 DSMB Data Safety Monitoring Board reviewed data from a planned interim analysis These data demonstrated that the investigational vaccine candidate was not effective and all vaccinations in the study were halted
Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective
Detailed Description:
No further treatment was given in V520-023 however participants were followed V520-023 protocol ended earlier than originally planned per protocol and participants HIV infected and uninfected had the option of participating in an observational long term follow up protocol called V520-030HVTN 504 which served as an extension of V520-023 and would continue through the end of 2009
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 |
|---|---|---|---|
| 2004_091 | None | None | None |