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

HIV Infections Clinical Trial

— THYMON-08001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848211
• Other study ID #: THYMON-08001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 13, 2009
• Last updated: February 17, 2011
• Start date: February 2009
• Est. completion date: May 2010

Study information

• Verified date: February 2011
• 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 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.

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: 24
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Placebo
Subcutaneous injection on Day 0, Day 28, and Day 84

Biological:
• TUTI-16 (0.03mg)
Subcutaneous injection on Day 0, Day 28, and Day 84
• TUTI-16 (0.1mg)
Subcutaneous injection on Day 0, Day 28, and Day 84
• TUTI-16 (0.6mg)
Subcutaneous injection on Day 0, Day 28, and Day 84

Locations

Country	Name	City	State
United States	Conant Medical Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Thymon, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Viral Load	Change in HIV viral load from baseline	baseline and 20 weeks	Yes
Primary	CD4+ T-cell Count	Change in CD4+ T-cell count from baseline	baseline and 20 weeks	Yes
Secondary	Determination of Anti-Tat Antibodies	Determination of change in anti-Tat antibody level	baseline and 16 weeks	No