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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thymon, LLC
ClinicalTrials.gov Identifier:
NCT01144026
First received: June 12, 2010
Last updated: January 11, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Biological: TUTI-16 (0.2mg)
Biological: TUTI-16 (1.0 mg)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Thymon, LLC:

Primary Outcome Measures:
  • anti-Tat antibody titer [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    determine the anti-Tat antibody response


Secondary Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Physical exam, vital signs, local injection site reactions, laboratory parameters, unsolicited and solicited AE reports.


Enrollment: 15
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144026

Locations
United States, New York
Clinilabs
New York, New York, United States, 10019
Sponsors and Collaborators
Thymon, LLC
Investigators
Principal Investigator: Mardik Donikyan, MD Clinilabs
  More Information

No publications provided

Responsible Party: Thymon, LLC
ClinicalTrials.gov Identifier: NCT01144026     History of Changes
Other Study ID Numbers: THYMON-10001
Study First Received: June 12, 2010
Last Updated: January 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Thymon, LLC:
HIV
vaccine
lipopeptide
 Tat
TUTI-16
THYMON

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 17, 2012