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

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ClinicalTrials.gov Identifier: NCT00848211
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : February 21, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Thymon, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Placebo Biological: TUTI-16 (0.03mg) Biological: TUTI-16 (0.1mg) Biological: TUTI-16 (0.6mg) 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Study Start Date : February 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. HIV Viral Load [ Time Frame: baseline and 20 weeks ]
    Change in HIV viral load from baseline

  2. CD4+ T-cell Count [ Time Frame: baseline and 20 weeks ]
    Change in CD4+ T-cell count from baseline


Secondary Outcome Measures :
  1. Determination of Anti-Tat Antibodies [ Time Frame: baseline and 16 weeks ]
    Determination of change in anti-Tat antibody level



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00848211


Locations
United States, California
Conant Medical Clinical Research
San Francisco, California, United States, 94114
Sponsors and Collaborators
Thymon, LLC
Investigators
Principal Investigator: Marcus A Conant, MD Conant Medical Clinical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gideon Goldstein, MD, PhD, THYMON, LLC
ClinicalTrials.gov Identifier: NCT00848211     History of Changes
Other Study ID Numbers: THYMON-08001
First Posted: February 20, 2009    Key Record Dates
Results First Posted: February 21, 2011
Last Update Posted: February 24, 2011
Last Verified: February 2011

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

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