Title
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Phase
Phase 1/Phase 2Lead Sponsor
Thymon, LLCStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HIV InfectionsIntervention/Treatment
syngem ...Study Participants
24This 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.
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.
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Inclusion Criteria: Males and Females Age ≥18 and ≤50 years at Screening HIV-1 seropositive asymptomatic and in generally good health no prior anti-retroviral therapy within 6 months of screening viral load ≥ 3,000 ≤ 100,000 HIV-1 RNA copies/mL CD4+ T-cell count ≥ 400/mm3. Exclusion Criteria: Pregnant/nursing females positive for HBV or HCV acute Herpetic event any clinically significant out-of range laboratory value subject is unable or unwilling to discontinue during the study participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.
| Event Type | Organ System | Event Term | Group 1 (0.03mg TUTI-16) | Group 2 (0.1mg TUTI-16) | Group 3 (0.6mg TUTI-16) | Placebo |
|---|
Change in HIV viral load from baseline
Change in CD4+ T-cell count from baseline
Determination of change in anti-Tat antibody level
