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Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

NCT01144026 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-01-18

Study results available
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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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

TUTI-16 (0.2mg)

Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.

BIOLOGICAL

TUTI-16 (1.0 mg)

Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.

Sponsors & Collaborators

  • Thymon, LLC

    lead INDUSTRY

Principal Investigators

  • Mardik Donikyan, MD · Clinilabs, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-04-30
Completion
2011-04-30

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 NCT01144026 on ClinicalTrials.gov