Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT01144026

Run by

Thymon, LLC

People needed

15

Starts

2010-09-01

Expected to finish

2011-04-01

Last updated by the study team

2013-01-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinilabs — New York, New York, United States

Full record on ClinicalTrials.gov

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