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

This study has been completed.
Sponsor:
Information provided by:
Thymon, LLC
ClinicalTrials.gov Identifier:
NCT00848211
First received: February 13, 2009
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
HIV Infections
Other: Placebo
Biological: TUTI-16 (0.03mg)
Biological: TUTI-16 (0.1mg)
Biological: TUTI-16 (0.6mg)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

Resource links provided by NLM:


Further study details as provided by Thymon, LLC:

Primary Outcome Measures:
  • HIV Viral Load [ Time Frame: baseline and 20 weeks ] [ Designated as safety issue: Yes ]
    Change in HIV viral load from baseline

  • CD4+ T-cell Count [ Time Frame: baseline and 20 weeks ] [ Designated as safety issue: Yes ]
    Change in CD4+ T-cell count from baseline


Secondary Outcome Measures:
  • Determination of Anti-Tat Antibodies [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
    Determination of change in anti-Tat antibody level


Enrollment: 24
Study Start Date: February 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Thymon, LLC

Additional 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
Study First Received: February 13, 2009
Results First Received: June 12, 2010
Last Updated: February 17, 2011
Health Authority: United States: Food and Drug Administration

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

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 July 26, 2014