Clinical trial NCT00848211: Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Official title: Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
vaccine
lipopeptide
Tat
TUTI-16
THYMON
Treatment Naive
Lead sponsor: Thymon, LLC
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: HIV Viral Load
timeFrame: baseline and 20 weeks
measure: CD4+ T-cell Count
timeFrame: baseline and 20 weeks
Secondary outcomes:
measure: Determination of Anti-Tat Antibodies
timeFrame: baseline and 16 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Conant Medical Clinical Research
state: California
Study officials:
affiliation: Conant Medical Clinical Research
name: Marcus A Conant, 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.