At a glance
ClinicalIndex Comparison Record- ✓Age 18–50 years at screening
- ✓HIV-1 seropositive
- ✓Asymptomatic and in generally good health
- ✓No prior antiretroviral therapy within 6 months of screening
- ✕Pregnant or nursing females
- ✕Hepatitis B or C coinfection
- ✕Acute herpes simplex event
- ✕Any clinically significant out-of-range laboratory value
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
In Brief
A Phase 2 clinical trial evaluating Placebo, TUTI-16 (0.03mg), and 2 other interventions for HIV Infections. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84
Subcutaneous injection on Day 0, Day 28, and Day 84