Phase 2 Completed N=24 Randomized Quadruple-blind Treatment

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

HIV

Source: ClinicalTrials.gov NCT00848211 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2011

Primary outcomePrimary: HIV Viral Load — -0.18; -0.05; 0.002; 0.26 HIV RNA copies/mL — p=0.008

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.