Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-08001)

February 17, 2011 updated by: Thymon, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94114
        • Conant Medical Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Subcutaneous injection on Day 0, Day 28, and Day 84
Experimental: TUTI-16 0.03 mg
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
Experimental: TUTI-16 0.1 mg
Subcutaneous injection on Day 0, Day 28, and Day 84
Biological: TUTI-16 (0.1mg)
Subcutaneous injection on Day 0, Day 28, and Day 84
Experimental: TUTI-16 0.6 mg
Subcutaneous injection on Day 0, Day 28, and Day 84
Biological: TUTI-16 (0.6mg)
Subcutaneous injection on Day 0, Day 28, and Day 84

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV Viral Load
Time Frame: baseline and 20 weeks
Change in HIV viral load from baseline
baseline and 20 weeks
CD4+ T-cell Count
Time Frame: baseline and 20 weeks
Change in CD4+ T-cell count from baseline
baseline and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Anti-Tat Antibodies
Time Frame: baseline and 16 weeks
Determination of change in anti-Tat antibody level
baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thymon, LLC

Investigators

  • Principal Investigator: Marcus A Conant, MD, Conant Medical Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THYMON-08001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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