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NCT Number: NCT02443935

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department for Infectious Diseases, Aarhus University Hospital, Aarhus N, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGN1703

Drug

60 mg s.c. twice weekly for 4 weeks

Other names: TLR9 agonist, CpG oligodeoxynucleotides

Primary outcomes

  1. Part A: NK cell activation

    Time frame: 12 weeks

    As measured by CD69 expression

  2. 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 outcomes

  1. 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).

  2. The size of the HIV-1 reservoir

    Time frame: 12 weeks

    HIV DNA and others measures

  3. Viral transcription

    Time frame: 12 weeks

    Plasma HIV RNA and cell-associated unspliced HIV RNA

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Toll-like Receptor 9 Enhancement of Antiviral Immunity in Chronic HIV-1 Infection: a Phase 1b/2a Trial

Acronym: TEACH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 14, 2015
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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