Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Biological: TUTI-16 (0.2mg); Biological: TUTI-16 (1.0 mg)

• Registration Number: NCT01144026
• Lead Sponsor: Thymon, LLC

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-06-12
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Study Start: 2010-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-12-07
• Results First Submitted QC: 2012-12-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Results First Posted: 2013-01-15
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TUTI-16 (0.2mg)	TUTI-16 (0.2mg)	Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
TUTI-16 (1.0 mg)	TUTI-16 (1.0 mg)	Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.

Primary Outcome Measures

Name	Time	Method
Anti-Tat Antibody Titer	5 weeks	ELISA based chemiluminescent assay to determine the anti-Tat antibody response

Trial Locations

Locations (1)

Clinilabs; 🇺🇸 New York, New York, United States