Ignite Creation Date:
2024-05-05 @ 9:14 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00848211
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2009-02-13
Brief Title:
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Sponsor:
Thymon LLC
Organization:
Thymon LLC
Study Overview
Official Title:
Phase IIIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2011-02
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:
THYMON-08001
Brief Summary:
This protocol represents the first in human study of TUTI-16 and is being conducted to establish the safety and human immunogenicity anti-HIV-1 Tat titers of subcutaneously administered TUTI-16 Activity of TUTI-16 will also be determined in minimizing HIV-1 viral loads and sustaining CD4 T-cell levels
Detailed Description:
HIV-1 Tat protein a virally encoded toxin is secreted by HIV-1 infected cells and acts on uninfected cells rendering them permissive for HIV-1 replication HIV-1 Tat enhances chronic viral replication and induces immune suppression Antibodies to Tat inhibit this Tat-mediated transcellular activation in vitro and minimize chronic plasma viremia HIV-1 Tat activities can be blocked in vitro and in vivo by anti-Tat antibodies
The Thymon Universal Tat Immunogen TUTI-16 is a fully synthetic self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection In preclinical studies a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein These antibodies block the function of the HIV-1 Tat protein toxin which is essential to the maintenance of chronic HIV-1 viremia Therefore TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans
The Thymon Universal Tat Immunogen TUTI-16 is a fully synthetic self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection In preclinical studies a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein These antibodies block the function of the HIV-1 Tat protein toxin which is essential to the maintenance of chronic HIV-1 viremia Therefore TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans
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