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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335191
• Other study ID #: THYMON-11001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 12, 2011
• Last updated: January 14, 2013
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Thymon, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• TUTI-16 (1.0 mg)
Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.

Other:
• Placebo
Two subcutaneous injections of Placebo at Day 0 and Week 3.

Locations

Country	Name	City	State
United States	Clinilabs	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Thymon, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Tat Antibody Titer	ELISA based chemiluminescent assay to determine the anti-Tat antibody response	54 weeks	No