Phase 2
Completed N=15
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Source: ClinicalTrials.gov NCT01144026 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Anti-Tat Antibody Titer — 401; 887 ng/mL
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 TUTI-16.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-Tat Antibody Titer |
401; 887 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01144026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.