This protocol represents the third in human study of TUTI-16, and is being conducted to gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.
In this study, HIV-1 infected subjects on ART, with undetectable HIV-1 viral load, will be immunized with 1mg TUTI-16 or placebo in a randomized double blind fashion (prime and 3 week boost). Three weeks after the 3 week boost (week 6) ART will be stopped. HIV-1 viral load and CD4+ T-cell levels will be determined at defined intervals through 54 weeks (48 weeks Post ART discontinuation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.
Two subcutaneous injections of Placebo at Day 0 and Week 3.
Clinilabs
New York, New York, United States
Anti-Tat Antibody Titer
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Time frame: 54 weeks
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