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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Biological: TUTI-16 (1.0 mg); Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Clinilabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-Tat Antibody Titer	ELISA based chemiluminescent assay to determine the anti-Tat antibody response	54 weeks

Collaborators and Investigators

• Sponsor: Thymon, LLC
• Investigators: Principal Investigator: Mardik Donikyan, MD, Clinilabs, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: HIV; vaccine; lipopeptide; Tat; TUTI-16; THYMON
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: THYMON-11001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No