Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01335191
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2011-04-12
Brief Title:
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects THYMON-11001
Sponsor:
Thymon LLC
Organization:
Thymon LLC
Study Overview
Official Title:
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects Effectively Controlled by Antiretroviral Therapy and the Effects on Viral Load During a Structured Treatment Interruption
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This protocol represents the third in human study of TUTI-16 and is being conducted to gather additional safety and human immunogenicity anti-HIV-1 Tat titers data of subcutaneously administered TUTI-16
Detailed Description:
In this study HIV-1 infected subjects on ART with undetectable HIV-1 viral load will be immunized with 1mg TUTI-16 or placebo in a randomized double blind fashion prime and 3 week boost Three weeks after the 3 week boost week 6 ART will be stopped HIV-1 viral load and CD4 T-cell levels will be determined at defined intervals through 54 weeks 48 weeks Post ART discontinuation
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