Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)
1 other identifier
interventional
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Jun 2011
1 active site
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
First Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 14, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
February 15, 2013
CompletedFebruary 15, 2013
January 1, 2013
1 year
April 12, 2011
December 7, 2012
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-Tat Antibody Titer
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
54 weeks
Study Arms (2)
TUTI-16 (1.0 mg)
EXPERIMENTALTwo subcutaneous injections of 1.0 mg at Day 0 and Week 3.
Placebo
PLACEBO COMPARATORTwo subcutaneous injections of placebo at Day 0 and Week 3.
Interventions
Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.
Eligibility Criteria
You may qualify if:
- Males and Females
- Age ≥ 18 and ≤ 50 years at Screening
- Body weight of 50-100 kg (inclusive) at Screening.
- HIV-1 seropositive subjects on effective ART for \> 12 months (undetectable HIV plasma viremia), viral set point before ART \> 10,000.
- CD4+ T-cell count ≥ 500/mm3.
- No antiviral drug within 8 weeks of screening. Patients stabilized on Aciclovir and Valciclovir for more than 6 months may be enrolled.
- Karnofsky performance status \> 90% at screening.
- In good health as determined by medical history, a baseline physical examination, vital signs, and clinical laboratory tests.
- Subject is willing and able to sign written informed consent prior to beginning study procedures.
- Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
You may not qualify if:
- Females planning to become pregnant during the course of the study.
- Females with a positive pregnancy test at Screening or study enrollment.
- Any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator.
- Systemic infection or other vaccination within 6 weeks prior to screening. Live vaccine within 1 year of screening.
- Autoimmune disease (e.g., psoriasis, rheumatoid arthritis, etc.) or inflammatory bowel disease confirmed by clinical history.
- Positive at screen for HBV (by HBsAg assay) or HCV (by antibody ELISA) unless there is no active infection as judged by an elevated alanine aminotransferase (ALT) at screening.
- Alanine aminotransferase (ALT) above the upper limit of normal at screening.
- Hemoglobin outside of laboratory normal range at screening.
- Absolute neutrophil counts outside of laboratory normal range at screening.
- Platelet count outside of laboratory normal range at screening.
- A history of significant drug allergy.
- A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent.
- Subjects experiencing an acute Herpetic event.
- Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator would make the subject unsuitable for the study or put them at additional risk.
- Routine or PRN consumption of immune suppressive medications that the subject is unable or unwilling to discontinue during the study.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thymon, LLClead
Study Sites (1)
Clinilabs
New York, New York, 10019, United States
Related Publications (1)
Goldstein G, Damiano E, Donikyan M, Pasha M, Beckwith E, Chicca J. HIV-1 Tat B-cell epitope vaccination was ineffectual in preventing viral rebound after ART cessation: HIV rebound with current ART appears to be due to infection with new endogenous founder virus and not to resurgence of pre-existing Tat-dependent viremia. Hum Vaccin Immunother. 2012 Oct;8(10):1425-30. doi: 10.4161/hv.21616. Epub 2012 Oct 1.
PMID: 23095869DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gideon Goldstein
- Organization
- Thymon LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Mardik Donikyan, MD
Clinilabs, Inc.
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 14, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 15, 2013
Results First Posted
February 15, 2013
Record last verified: 2013-01