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

Sponsored by:	Thymon, LLC
Information provided by:	Thymon, LLC
ClinicalTrials.gov Identifier:	NCT00848211

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	Biological: TUTI-16	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Thymon, LLC:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Three subcutaneous injections of 0.03 mg (cohort 1), 0.1 mg (cohort 2) or 0.3 mg (cohort 3) TUTI-16 vaccine or placebo at Day 0, Week 4 and Week 12.

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; 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: NCT00848211

Locations

United States, California
Conant Medical Clinical Research	Recruiting
San Francisco, California, United States, 94114
Contact: Marcus A Conant, MD 415-575-7500 marcconant@hotmail.com
Contact: Christopher L Eden, MD (415) 575 7500 ceden@conantmedical.org
Principal Investigator: Marcus A Conant, MD
Sub-Investigator: Christopher L Eden, MD

Sponsors and Collaborators

Thymon, LLC

Investigators

Principal Investigator:

Marcus A Conant, MD

Conant Medical Clinical Research

More Information

No publications provided

Responsible Party:	THYMON, LLC ( Gideon Goldstein, MD, PhD )
Study ID Numbers:	THYMON-08001
Study First Received:	February 13, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00848211 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thymon, LLC:

HIV
vaccine
lipopeptide
Tat

TUTI-16
THYMON
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on August 30, 2009