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

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ClinicalTrials.gov Identifier: NCT01144026
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : January 15, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Thymon, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: TUTI-16 (0.2mg) Biological: TUTI-16 (1.0 mg) Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Study Start Date : September 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Anti-Tat Antibody Titer [ Time Frame: 5 weeks ]
    ELISA based chemiluminescent assay to determine the anti-Tat antibody response


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144026


Locations
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United States, New York
Clinilabs
New York, New York, United States, 10019
Sponsors and Collaborators
Thymon, LLC
Investigators
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Principal Investigator: Mardik Donikyan, MD Clinilabs, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thymon, LLC
ClinicalTrials.gov Identifier: NCT01144026    
Other Study ID Numbers: THYMON-10001
First Posted: June 15, 2010    Key Record Dates
Results First Posted: January 15, 2013
Last Update Posted: January 18, 2013
Last Verified: January 2013
Keywords provided by Thymon, LLC:
HIV
vaccine
lipopeptide
 Tat
TUTI-16
THYMON
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases