Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00848211

Run by

Thymon, LLC

People needed

24

Starts

2009-02-01

Expected to finish

2010-05-01

Last updated by the study team

2011-02-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Conant Medical Clinical Research — San Francisco, California, United States

Full record on ClinicalTrials.gov

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