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

NCT00848211 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-02-24

Study results available
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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.

Conditions

  • HIV Infections

Interventions

OTHER

Placebo

Subcutaneous injection on Day 0, Day 28, and Day 84

BIOLOGICAL

TUTI-16 (0.03mg)

Subcutaneous injection on Day 0, Day 28, and Day 84

BIOLOGICAL

TUTI-16 (0.1mg)

Subcutaneous injection on Day 0, Day 28, and Day 84

BIOLOGICAL

TUTI-16 (0.6mg)

Subcutaneous injection on Day 0, Day 28, and Day 84

Sponsors & Collaborators

  • Thymon, LLC

    lead INDUSTRY

Principal Investigators

  • Marcus A Conant, MD · Conant Medical Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00848211 on ClinicalTrials.gov