Status:
COMPLETED
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Lead Sponsor:
Thymon, LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
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 ...
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 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01144026
Start Date
September 1 2010
End Date
April 1 2011
Last Update
January 18 2013
Active Locations (1)
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1
Clinilabs
New York, New York, United States, 10019