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

HIV Infections Clinical Trial

— THYMON-10001  

Official title:

Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144026
• Other study ID #: THYMON-10001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 12, 2010
• Last updated: January 14, 2013
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2013
• Source: Thymon, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• TUTI-16 (0.2mg)
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
• TUTI-16 (1.0 mg)
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.

Locations

Country	Name	City	State
United States	Clinilabs	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Thymon, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Tat Antibody Titer	ELISA based chemiluminescent assay to determine the anti-Tat antibody response	5 weeks	No