HIV InfectionsPhase 1/2THYMON-10001NCT01144026
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
A Phase 1/2 study testing TUTI-16 (0.2mg) and TUTI-16 (1.0 mg) in people with HIV Infections, run by Thymon, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TUTI-16 (0.2mg) and TUTI-16 (1.0 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2011
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and Females
- Age ≥18 and ≤50 years at Screening
- HIV negative healthy subjects or HIV-1 seropositive subjects on effective ART for >2 months (undetectable HIV plasma viremia), viral set point before ART >3,000
- CD4+ T-cell count ≥ 500/mm3.
Who cannot join
- Pregnant/nursing females
- Positive for HBV or HCV
- Acute Herpetic event
- Any clinically significant out-of range laboratory value
- Routine or PRN consumption of immune suppressive medications that the 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.
About this study
Official title: Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
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.
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
- TUTI-16 (0.2mg), TUTI-16 (1.0 mg)
- Keywords
- HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUTI-16 (0.2mg)Biological
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
TUTI-16 (1.0 mg)Biological
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
| Study group | Role | What they receive |
|---|---|---|
| TUTI-16 (0.2mg) | Experimental | Two subcutaneous injections of 0.2 mg at Day 0, and Week 5. Receives: Biological: TUTI-16 (0.2mg) |
| TUTI-16 (1.0 mg) | Experimental | Two subcutaneous injections of 1.0 mg at Day 0, and Week 5. Receives: Biological: TUTI-16 (1.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Tat Antibody Titer
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thymon, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mardik Donikyan, MD, Principal investigator, Clinilabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144026
- Sponsor's protocol ID
- THYMON-10001
- Acronym
- THYMON-10001
- Status last verified
- Jan 2013
- First submitted
- 12 Jun 2010
- Last updated
- 18 Jan 2013
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
- ClinicalTrials.gov ID
- NCT01144026
- Acronym / sponsor ID
- THYMON-10001 / THYMON-10001
- Conditions
- HIV Infections
- Keywords
- HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Thymon, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Posted 15 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUTI-16 (0.2mg) | Experimental | Biological: TUTI-16 (0.2mg)Two subcutaneous injections of 0.2 mg at Day 0, and Week 5. |
| TUTI-16 (1.0 mg) | Experimental | Biological: TUTI-16 (1.0 mg)Two subcutaneous injections of 1.0 mg at Day 0, and Week 5. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and Females
- Age ≥18 and ≤50 years at Screening
- HIV negative healthy subjects or HIV-1 seropositive subjects on effective ART for >2 months (undetectable HIV plasma viremia), viral set point before ART >3,000
- CD4+ T-cell count ≥ 500/mm3.
Key exclusion criteria (6 listed)
- Pregnant/nursing females
- Positive for HBV or HCV
- Acute Herpetic event
- Any clinically significant out-of range laboratory value
- Routine or PRN consumption of immune suppressive medications that the 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 |
|---|---|---|
| TUTI-16 (0.2mg)Two subcutaneous injections of 0.2 mg at Day 0, and Week 5. | Biological | TUTI-16 (0.2mg) |
| TUTI-16 (1.0 mg)Two subcutaneous injections of 1.0 mg at Day 0, and Week 5. | Biological | TUTI-16 (1.0 mg) |
Primary outcome
Anti-Tat Antibody Titer
Time frame: 5 weeks
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- 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.
Mardik Donikyan, MD principal investigator
Clinilabs, Inc.
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 (0.2mg) and TUTI-16 (1.0 mg) 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 4 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 18 Jan 2013. 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. 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 15 Jan 2013). 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?
Anti-Tat Antibody Titer (time frame: 5 weeks). 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 NCT01144026, 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 18 Jan 2013.