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

February 13, 2009
February 17, 2011
February 2009
May 2010   (final data collection date for primary outcome measure)
  • 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
To determine vaccine activity and safety with respect to clinical, hematological, and biochemical parameters, including HIV viral loads and CD4+ T-cell counts. [ Time Frame: through 20 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00848211 on ClinicalTrials.gov Archive Site
Determination of Anti-Tat Antibodies [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Determination of change in anti-Tat antibody level
To determine the ability to mount an immune response specific to the HIV-1 Tat protein (all eight variants). [ Time Frame: through 20 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Other: Placebo
    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
  • Biological: TUTI-16 (0.1mg)
    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
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: TUTI-16 0.03 mg
    Subcutaneous injection on Day 0, Day 28, and Day 84
    Intervention: Biological: TUTI-16 (0.03mg)
  • Experimental: TUTI-16 0.1 mg
    Subcutaneous injection on Day 0, Day 28, and Day 84
    Intervention: Biological: TUTI-16 (0.1mg)
  • Experimental: TUTI-16 0.6 mg
    Subcutaneous injection on Day 0, Day 28, and Day 84
    Intervention: Biological: TUTI-16 (0.6mg)
Goldstein G, Chicca JJ. Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naïve and antiretroviral-controlled HIV-1 infected subjects plus healthy uninfected subjects. Hum Vaccin Immunother. 2012 Apr;8(4):479-85. doi: 10.4161/hv.19184. Epub 2012 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00848211
THYMON-08001
No
Gideon Goldstein, MD, PhD, THYMON, LLC
Thymon, LLC
Not Provided
Principal Investigator: Marcus A Conant, MD Conant Medical Clinical Research
Thymon, LLC
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP