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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
TUTI-16 (0.03mg)
TUTI-16 (0.1mg)
TUTI-16 (0.6mg)
Sponsored by
Thymon, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON, Treatment Naive

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Conant Medical Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

TUTI-16 0.03 mg

TUTI-16 0.1 mg

TUTI-16 0.6 mg

Arm Description

Subcutaneous injection on Day 0, Day 28, and Day 84

Subcutaneous injection on Day 0, Day 28, and Day 84

Subcutaneous injection on Day 0, Day 28, and Day 84

Outcomes

Primary Outcome Measures

HIV Viral Load
Change in HIV viral load from baseline
CD4+ T-cell Count
Change in CD4+ T-cell count from baseline

Secondary Outcome Measures

Determination of Anti-Tat Antibodies
Determination of change in anti-Tat antibody level

Full Information

First Posted
February 13, 2009
Last Updated
February 17, 2011
Sponsor
Thymon, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00848211
Brief Title
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Acronym
THYMON-08001
Official Title
Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Thymon, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
TUTI-16 0.03 mg
Arm Type
Experimental
Arm Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Arm Title
TUTI-16 0.1 mg
Arm Type
Experimental
Arm Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Arm Title
TUTI-16 0.6 mg
Arm Type
Experimental
Arm Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention Type
Biological
Intervention Name(s)
TUTI-16 (0.03mg)
Intervention Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention Type
Biological
Intervention Name(s)
TUTI-16 (0.1mg)
Intervention Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Intervention Type
Biological
Intervention Name(s)
TUTI-16 (0.6mg)
Intervention Description
Subcutaneous injection on Day 0, Day 28, and Day 84
Primary Outcome Measure Information:
Title
HIV Viral Load
Description
Change in HIV viral load from baseline
Time Frame
baseline and 20 weeks
Title
CD4+ T-cell Count
Description
Change in CD4+ T-cell count from baseline
Time Frame
baseline and 20 weeks
Secondary Outcome Measure Information:
Title
Determination of Anti-Tat Antibodies
Description
Determination of change in anti-Tat antibody level
Time Frame
baseline and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus A Conant, MD
Organizational Affiliation
Conant Medical Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Conant Medical Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22336878
Citation
Goldstein G, Chicca JJ. Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naive 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.
Results Reference
derived

Learn more about this trial

Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

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