Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thymon, LLC
ClinicalTrials.gov Identifier:
NCT01335191
First received: April 12, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: TUTI-16 (1.0 mg)
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of TUTI-16 in Asymptomatic, HIV-1 Infected Subjects Effectively Controlled by Antiretroviral Therapy and the Effects on Viral Load During a Structured Treatment Interruption

Resource links provided by NLM:


Further study details as provided by Thymon, LLC:

Primary Outcome Measures:
  • Anti-Tat Antibody Titer [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    ELISA based chemiluminescent assay to determine the anti-Tat antibody response


Enrollment: 27
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TUTI-16 (1.0 mg)
Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
Biological: TUTI-16 (1.0 mg)
Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.
Placebo Comparator: Placebo
Two subcutaneous injections of placebo at Day 0 and Week 3.
Other: Placebo
Two subcutaneous injections of Placebo at Day 0 and Week 3.

Detailed Description:

In this study, HIV-1 infected subjects on ART, with undetectable HIV-1 viral load, will be immunized with 1mg TUTI-16 or placebo in a randomized double blind fashion (prime and 3 week boost). Three weeks after the 3 week boost (week 6) ART will be stopped. HIV-1 viral load and CD4+ T-cell levels will be determined at defined intervals through 54 weeks (48 weeks Post ART discontinuation).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Inability to understand or follow study instructions.
  • Participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335191

Locations
United States, New York
Clinilabs
New York, New York, United States, 10019
Sponsors and Collaborators
Thymon, LLC
Investigators
Principal Investigator: Mardik Donikyan, MD Clinilabs
  More Information

No publications provided by Thymon, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thymon, LLC
ClinicalTrials.gov Identifier: NCT01335191     History of Changes
Other Study ID Numbers: THYMON-11001
Study First Received: April 12, 2011
Results First Received: December 7, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Thymon, LLC:
HIV
vaccine
lipopeptide
Tat
TUTI-16
THYMON

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014