NCT00848211

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 21, 2011

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

1.2 years

First QC Date

February 13, 2009

Results QC Date

June 12, 2010

Last Update Submit

February 17, 2011

Conditions

HIV Infections

Keywords

HIVvaccinelipopeptideTatTUTI-16THYMONTreatment Naive

Outcome Measures

Primary Outcomes (2)

  • HIV Viral Load

    Change in HIV viral load from baseline

    baseline and 20 weeks

  • CD4+ T-cell Count

    Change in CD4+ T-cell count from baseline

    baseline and 20 weeks

Secondary Outcomes (1)

  • Determination of Anti-Tat Antibodies

    baseline and 16 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Other: Placebo

TUTI-16 0.03 mg

EXPERIMENTAL

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

Biological: TUTI-16 (0.03mg)

TUTI-16 0.1 mg

EXPERIMENTAL

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

Biological: TUTI-16 (0.1mg)

TUTI-16 0.6 mg

EXPERIMENTAL

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

Biological: TUTI-16 (0.6mg)

Interventions

PlaceboOTHER

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

Placebo
TUTI-16 (0.03mg)BIOLOGICAL

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

TUTI-16 0.03 mg
TUTI-16 (0.1mg)BIOLOGICAL

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

TUTI-16 0.1 mg
TUTI-16 (0.6mg)BIOLOGICAL

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

TUTI-16 0.6 mg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females
  • Age ≥18 and ≤50 years at Screening
  • HIV-1 seropositive
  • asymptomatic and in generally good health
  • no prior anti-retroviral therapy within 6 months of screening
  • viral load ≥ 3,000 ≤ 100,000 HIV-1 RNA copies/mL
  • CD4+ T-cell count ≥ 400/mm3.

You may not qualify if:

  • Pregnant/nursing females
  • positive for HBV or HCV
  • acute Herpetic event
  • any clinically significant out-of range laboratory value
  • subject is unable or unwilling to discontinue during the study
  • participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Conant Medical Clinical Research

San Francisco, California, 94114, United States

Location

Related Publications (1)

  • Goldstein G, Chicca JJ. Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naive and antiretroviral-controlled HIV-1 infected subjects plus healthy uninfected subjects. Hum Vaccin Immunother. 2012 Apr;8(4):479-85. doi: 10.4161/hv.19184. Epub 2012 Feb 16.

    PMID: 22336878DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Gideon Goldstein, MD, PhD
Organization
Thymon LLC
gidgold@gmail.com
(973) 467-9558

Study Officials

  • Marcus A Conant, MD

    Conant Medical Clinical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 20, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 24, 2011

Results First Posted

February 21, 2011

Record last verified: 2011-02

Locations

US(1)