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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01335191
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Thymon, LLC

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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Anti-Tat Antibody Titer [ Time Frame: 54 weeks ]
    ELISA based chemiluminescent assay to determine the anti-Tat antibody response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01335191

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United States, New York
New York, New York, United States, 10019
Sponsors and Collaborators
Thymon, LLC
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Principal Investigator: Mardik Donikyan, MD Clinilabs, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thymon, LLC Identifier: NCT01335191    
Other Study ID Numbers: THYMON-11001
First Posted: April 14, 2011    Key Record Dates
Results First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: January 2013
Keywords provided by Thymon, LLC:
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases