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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Other: Placebo; Biological: TUTI-16 (0.03mg); Biological: TUTI-16 (0.1mg); Biological: TUTI-16 (0.6mg)

• Registration Number: NCT00848211
• Lead Sponsor: Thymon, LLC

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2010-06-12
• Results First Submitted QC: 2011-01-23
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Results First Posted: 2011-02-21
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TUTI-16 0.03 mg	TUTI-16 (0.03mg)	Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 0.1 mg	TUTI-16 (0.1mg)	Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 0.6 mg	TUTI-16 (0.6mg)	Subcutaneous injection on Day 0, Day 28, and Day 84

Primary Outcome Measures

Name	Time	Method
HIV Viral Load	baseline and 20 weeks	Change in HIV viral load from baseline
CD4+ T-cell Count	baseline and 20 weeks	Change in CD4+ T-cell count from baseline

Secondary Outcome Measures

Name	Time	Method
Determination of Anti-Tat Antibodies	baseline and 16 weeks	Determination of change in anti-Tat antibody level

Trial Locations

Locations (1)

Conant Medical Clinical Research; 🇺🇸 San Francisco, California, United States