Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

Thymon, LLC24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV Infections

Interventions

PlaceboOTHER

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

TUTI-16 (0.03mg)BIOLOGICAL

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

TUTI-16 (0.1mg)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Conant Medical Clinical Research

San Francisco, California, United States

Outcomes

Primary Outcomes

HIV Viral Load

Change in HIV viral load from baseline

Time frame: baseline and 20 weeks

CD4+ T-cell Count

Change in CD4+ T-cell count from baseline

Time frame: baseline and 20 weeks

Secondary Outcomes

Determination of Anti-Tat Antibodies

Determination of change in anti-Tat antibody level

Time frame: baseline and 16 weeks

Data from ClinicalTrials.gov

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