HIV InfectionsPhase 1/2THYMON-08001NCT00848211

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

A Phase 1/2 study testing TUTI-16 (0.03mg), TUTI-16 (0.1mg) and TUTI-16 (0.6mg) in people with HIV Infections, run by Thymon, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: HIV Infections
What is being tested?: TUTI-16 (0.03mg), TUTI-16 (0.1mg) and TUTI-16 (0.6mg)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Feb 2009to May 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Conant Medical Clinical Research
San Francisco, California, 94114

Other trials in United States

About this study

Official title: Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

Read the detailed description

HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities can be blocked in vitro and in vivo by anti-Tat antibodies.

The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans.

Conditions: HIV Infections
Being tested: Placebo, TUTI-16 (0.03mg), TUTI-16 (0.1mg), TUTI-16 (0.6mg)
Keywords: HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON, Treatment Naive
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 (0.03mg)Biological
Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 (0.1mg)Biological
Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 (0.6mg)Biological
Subcutaneous injection on Day 0, Day 28, and Day 84

Study groups in NCT00848211
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Other: Placebo
TUTI-16 0.03 mg	Experimental	Subcutaneous injection on Day 0, Day 28, and Day 84 Receives: Biological: TUTI-16 (0.03mg)
TUTI-16 0.1 mg	Experimental	Subcutaneous injection on Day 0, Day 28, and Day 84 Receives: Biological: TUTI-16 (0.1mg)
TUTI-16 0.6 mg	Experimental	Subcutaneous injection on Day 0, Day 28, and Day 84 Receives: Biological: TUTI-16 (0.6mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

HIV Viral Load
Change in HIV viral load from baseline
Measured: baseline and 20 weeks
CD4+ T-cell Count
Change in CD4+ T-cell count from baseline
Measured: baseline and 20 weeks

Secondary outcomes (1)

Determination of Anti-Tat Antibodies
Determination of change in anti-Tat antibody level
Measured: baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009May 2010

First posted20 Feb 2009 (estimated)
Study startFeb 2009
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00848211
Sponsor's protocol ID: THYMON-08001
Acronym: THYMON-08001
Status last verified: Feb 2011
First submitted: 13 Feb 2009
Last updated: 24 Feb 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22336878

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/IIA Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
ClinicalTrials.gov ID: NCT00848211
Acronym / sponsor ID: THYMON-08001 / THYMON-08001
Conditions: HIV Infections
Keywords: HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON, Treatment Naive
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Thymon, LLCIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 20 Feb 2009 (estimated)
Results: Posted 21 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo
TUTI-16 0.03 mg	Experimental	Biological: TUTI-16 (0.03mg)Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 0.1 mg	Experimental	Biological: TUTI-16 (0.1mg)Subcutaneous injection on Day 0, Day 28, and Day 84
TUTI-16 0.6 mg	Experimental	Biological: TUTI-16 (0.6mg)Subcutaneous injection on Day 0, Day 28, and Day 84

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboSubcutaneous injection on Day 0, Day 28, and Day 84	Other	Placebo
TUTI-16 (0.03mg)Subcutaneous injection on Day 0, Day 28, and Day 84	Biological	TUTI-16 0.03 mg
TUTI-16 (0.1mg)Subcutaneous injection on Day 0, Day 28, and Day 84	Biological	TUTI-16 0.1 mg
TUTI-16 (0.6mg)Subcutaneous injection on Day 0, Day 28, and Day 84	Biological	TUTI-16 0.6 mg

Primary outcome

HIV Viral Load
Time frame: baseline and 20 weeks
Change in HIV viral load from baseline
CD4+ T-cell Count
Time frame: baseline and 20 weeks
Change in CD4+ T-cell count from baseline

1 secondary outcome

Determination of Anti-Tat Antibodies
Time frame: baseline and 16 weeks

Results and safety

Results posted to the registry on 21 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (0.03mg TUTI-16)	6	6
Group 2 (0.1mg TUTI-16)	7	6
Group 3 (0.6mg TUTI-16)	6	5
Placebo	5	5

Primary outcome: HIV Viral Load

Time frame: baseline and 20 weeks. Log mean (Standard Error). Unit: HIV RNA copies/mL

Measure	Group 1 (0.03mg TUTI-16) n = 6	Group 2 (0.1mg TUTI-16) n = 6	Group 3 (0.6mg TUTI-16) n = 5	Placebo n = 5
Value	-0.18 (0.12)	-0.05 (0.13)	0.002 (0.11)	0.26 (0.56)

Group 1 (0.03mg TUTI-16) vs Group 2 (0.1mg TUTI-16) vs Group 3 (0.6mg TUTI-16) vs Placebo: p = 0.008, ANOVA

Primary outcome: CD4+ T-cell Count

Time frame: baseline and 20 weeks. Log mean (Standard Error). Unit: cells/mm3

Measure	Group 1 (0.03mg TUTI-16) n = 6	Group 2 (0.1mg TUTI-16) n = 6	Group 3 (0.6mg TUTI-16) n = 5	Placebo n = 5
Value	-65 (48)	-116 (56)	14 (53)	-59 (22)

Group 1 (0.03mg TUTI-16) vs Group 2 (0.1mg TUTI-16) vs Group 3 (0.6mg TUTI-16) vs Placebo: p = 0.045, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (0.03mg TUTI-16)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Group 2 (0.1mg TUTI-16)	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
Group 3 (0.6mg TUTI-16)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Placebo	0 of 5 (0%)	4 of 5 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22336878Goldstein 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcus A Conant, MD principal investigator

Conant Medical Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TUTI-16 (0.03mg), TUTI-16 (0.1mg) and TUTI-16 (0.6mg) in people with HIV Infections, run by Thymon, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV Viral Load (time frame: baseline and 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00848211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.