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Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection (TEACH)

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.
 
ClinicalTrials.gov Identifier: NCT02443935
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE April 30, 2015
First Posted Date  ICMJE May 14, 2015
Last Update Posted Date June 29, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Part A: NK cell activation [ Time Frame: 12 weeks ]
    As measured by CD69 expression
  • Part B: Quantification of the size of the HIV reservoir [ Time Frame: 32 weeks ]
    As measured by quantitative viral outgrowth (qVOA) and total HIV DNA
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
NK cell activation [ Time Frame: 12 weeks ]
As measured by CD69 expression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Safety and tolerability, as measured by adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and suspected unexpected serious adverse reactions (SUSAR). [ Time Frame: 12 weeks ]
    Safety evaluation, as measured by adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and suspected unexpected serious adverse reactions (SUSAR).
  • The size of the HIV-1 reservoir [ Time Frame: 12 weeks ]
    HIV DNA and others measures
  • Viral transcription [ Time Frame: 12 weeks ]
    Plasma HIV RNA and cell-associated unspliced HIV RNA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2015)
Effects of MGN1703 on T and NK cell activation in the gut [ Time Frame: 12 weeks ]
Changes in the expression of activation markers such as CD69.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection
Official Title  ICMJE Toll-like Receptor 9 Enhancement of Antiviral Immunity in Chronic HIV-1 Infection: a Phase 1b/2a Trial
Brief Summary

Combination antiretroviral treatment (cART) effectively suppresses virus replication and partially restores immune functions. However, cART cannot cure HIV infection.

This study aim to investigate whether the antiviral immune response can be enhanced and/or viral transcription reactivated with MGN1703. MGN1703 is an agonist to toll-like receptor (TLR) 9. Activation of TLR9 has been shown to augment innate and adaptive immune effector functions, most notably enhanced NK cell and T cell functions.

Furthermore, TLR9 agonists have been shown in vitro to reactivate viral transcription in latently infected cells, potentially leading to enhanced recognition of infected cells by the immune effector cells.

Detailed Description

In Part A, participants will receive 4 weeks MGN1703 therapy (60 mg s.c. twice weekly). During the 4 weeks, participants will be closely monitored for safety and therapeutic effects of the drug. Targeted enrolment in Part A is 14-16 study subjects.

In Part B, participants will receive 24 weeks of MGN1703 therapy (60 mg s.c. twice weekly). During the 24 weeks, participants will be frequently monitored for safety and therapeutic effects of the drug. Targeted enrolment in Part B is 10-12 study subjects, preferentially recruited from part A.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: MGN1703
    60 mg s.c. twice weekly for 4 weeks
    Other Names:
    • TLR9 agonist
    • CpG oligodeoxynucleotides
  • Drug: MGN1703
    60 mg s.c. twice weekly for 24 weeks
    Other Names:
    • TLR9 agonist
    • CpG oligodeoxynucleotides
Study Arms  ICMJE Experimental: MGN1703
TLR-9 agonist MGN1703 administered to HIV-1 positive patients on cART
Interventions:
  • Drug: MGN1703
  • Drug: MGN1703
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
16
Actual Study Completion Date  ICMJE June 25, 2017
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented HIV-1 infection
  • Age >18 years
  • CD4+ T-cell count >350/µL at screening
  • On cART (for a minimum of 12 months)
  • Able to give informed consent.

Exclusion Criteria:

  • Pregnancy as determined by a positive urine beta-hCG (if female)
  • Males or females who are unwilling or unable to use barrier contraception during sexual intercourse for the entire study period.
  • Currently breast-feeding (if female)
  • Viral load (HIV RNA) > 50 copies/mL
  • Contraindication to receive MGN1703 as per current investigator brochure
  • Presence of acute bacterial infection or undiagnosed febrile condition
  • Concurrent chronic systemic immune therapy or immunosuppressant medication, including continuous systemic steroid treatment within the last 2 weeks prior to randomization
  • Use of antibiotic therapy within the last 2 weeks prior to randomization
  • Known HBV or HCV infection
  • Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia)
  • Unable to follow protocol regimen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02443935
Other Study ID Numbers  ICMJE TEA-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lars J Østergaard, MD,PhD,DMSc Department for Infectious Diseases, Aarhus University Hospital, Denmark
PRS Account University of Aarhus
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP