At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
TUTI-16 (0.2mg) +1 morebiological
Likely dose
TUTI-16 (0.2mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
In Brief
A Phase 2 clinical trial evaluating TUTI-16 (0.2mg) and TUTI-16 (1.0 mg) for HIV Infections. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartSep 2010
Primary CompletionApr 2011
TodayJul 2026
First PostedJun 15, 2010
Enrollment StartSep 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.0 years ago
Interventions
TUTI-16 (0.2mg)biological
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
TUTI-16 (1.0 mg)biological
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.