Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
| Status: | Archived |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2010 |
| End Date: | September 2011 |
Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
This protocol represents the second in human study of TUTI-16, and is being conducted to
continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of
subcutaneously administered TUTI-16.
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.
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