Status:
COMPLETED
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Lead Sponsor:
Thymon, LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
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. Ac...
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 replicat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00848211
Start Date
February 1 2009
End Date
May 1 2010
Last Update
February 24 2011
Active Locations (1)
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1
Conant Medical Clinical Research
San Francisco, California, United States, 94114