Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-08001)

Thymon, LLC

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV Infections

Treatments: Other: Placebo; Biological: TUTI-16 (0.03mg); Biological: TUTI-16 (0.1mg); Biological: TUTI-16 (0.6mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848211

THYMON-08001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

TUTI-16 0.03 mg

Experimental group

Description:

Subcutaneous injection on Day 0, Day 28, and Day 84

Treatment:

Biological: TUTI-16 (0.03mg)

TUTI-16 0.1 mg

Experimental group

Description:

Subcutaneous injection on Day 0, Day 28, and Day 84

Treatment:

Biological: TUTI-16 (0.1mg)

TUTI-16 0.6 mg

Experimental group

Description:

Subcutaneous injection on Day 0, Day 28, and Day 84

Treatment:

Biological: TUTI-16 (0.6mg)