Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Thymon, LLC
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- HIV Viral Load
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Intervention: Placebo (Other)
TUTI-16 0.03 mg
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention: TUTI-16 (0.03mg) (Biological)
TUTI-16 0.1 mg
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention: TUTI-16 (0.1mg) (Biological)
TUTI-16 0.6 mg
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention: TUTI-16 (0.6mg) (Biological)
Outcomes
Primary Outcomes
HIV Viral Load
Time Frame: baseline and 20 weeks
Change in HIV viral load from baseline
CD4+ T-cell Count
Time Frame: baseline and 20 weeks
Change in CD4+ T-cell count from baseline
Secondary Outcomes
- Determination of Anti-Tat Antibodies(baseline and 16 weeks)