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Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)

NCT01335191 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-02-15

Study results available
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Summary

This protocol represents the third in human study of TUTI-16, and is being conducted to gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

TUTI-16 (1.0 mg)

Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.

OTHER

Placebo

Two subcutaneous injections of Placebo at Day 0 and Week 3.

Sponsors & Collaborators

  • Thymon, LLC

    lead INDUSTRY

Principal Investigators

  • Mardik Donikyan, MD · Clinilabs, Inc.

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
2011-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT01335191 on ClinicalTrials.gov