Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects (THYMON-10001)

Thymon, LLC

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV Infections

Treatments: Biological: TUTI-16 (0.2mg); Biological: TUTI-16 (1.0 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01144026

THYMON-10001

Details and patient eligibility

About

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.

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: 15 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and Females
• Age ≥18 and ≤50 years at Screening
• HIV negative healthy subjects or HIV-1 seropositive subjects on effective ART for >2 months (undetectable HIV plasma viremia), viral set point before ART >3,000
• CD4+ T-cell count ≥ 500/mm3.

Exclusion criteria

• Pregnant/nursing females
• Positive for HBV or HCV
• Acute Herpetic event
• Any clinically significant out-of range laboratory value
• Routine or PRN consumption of immune suppressive medications that the 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

TUTI-16 (0.2mg)

Experimental group

Description:

Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.

Treatment:

Biological: TUTI-16 (0.2mg)

TUTI-16 (1.0 mg)

Experimental group

Description:

Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.

Treatment:

Biological: TUTI-16 (1.0 mg)