Phase 2
N=24
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00848211 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: HIV Viral Load — -0.18; -0.05; 0.002; 0.26 HIV RNA copies/mL — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Other); TUTI-16 (0.03mg) (Biological); TUTI-16 (0.1mg) (Biological); TUTI-16 (0.6mg) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thymon, LLC
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Viral Load |
-0.18; -0.05; 0.002; 0.26 | 0.008 sig |
| PRIMARY CD4+ T-cell Count |
-65; -116; 14; -59 | 0.045 sig |
| SECONDARY Determination of Anti-Tat Antibodies |
20; 84; 84; 20 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00848211). 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.