Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects (THYMON-10001)

January 14, 2013 updated by: Thymon, LLC

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

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.

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)

15

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
    • New York
      • New York, New York, United States, 10019
        • Clinilabs

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 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 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TUTI-16 (0.2mg)
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
Biological: TUTI-16 (0.2mg)
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
Experimental: TUTI-16 (1.0 mg)
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
Biological: TUTI-16 (1.0 mg)
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Tat Antibody Titer
Time Frame: 5 weeks
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
5 weeks

Collaborators and Investigators

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

Sponsor

Thymon, LLC

Investigators

  • Principal Investigator: Mardik Donikyan, MD, Clinilabs, Inc.

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

September 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 12, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THYMON-10001

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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