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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02443935
First received: April 30, 2015
Last updated: June 28, 2017
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
HIV Drug: MGN1703 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Toll-like Receptor 9 Enhancement of Antiviral Immunity in Chronic HIV-1 Infection: a Phase 1b/2a Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: April 2015
Study Completion Date: June 25, 2017
Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGN1703
TLR-9 agonist MGN1703 administered to HIV-1 positive patients on cART
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02443935

Locations
Denmark
Department for Infectious Diseases, Aarhus University Hospital
Aarhus N, Denmark, 8200
Department for Infectious Diseases, Amager and Hvidovre Hospitals
Hvidovre, Denmark, 2650
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Lars J Østergaard, MD,PhD,DMSc Department for Infectious Diseases, Aarhus University Hospital, Denmark
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02443935     History of Changes
Other Study ID Numbers: TEA-001
Study First Received: April 30, 2015
Last Updated: June 28, 2017

Additional relevant MeSH terms:
CPG-oligonucleotide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017