Clinical trial NCT01144026: Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Official title: Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
vaccine
lipopeptide
Tat
TUTI-16
THYMON
Lead sponsor: Thymon, LLC
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol represents the second in human study of TUTI-16, and is being conducted to continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.

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 criteria: Inclusion Criteria:

* Males and Females
* Age ≥18 and ≤50 years at Screening
* HIV negative healthy subjects or HIV-1 seropositive subjects on effective ART for \>2 months (undetectable HIV plasma viremia), viral set point before ART \>3,000
* CD4+ T-cell count ≥ 500/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.

Primary outcomes:
measure: Anti-Tat Antibody Titer
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinilabs
state: New York
Study officials:
affiliation: Clinilabs, Inc.
name: Mardik Donikyan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.