Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection (TEACH)
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|ClinicalTrials.gov Identifier: NCT02443935|
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : June 29, 2017
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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 or disease||Intervention/treatment||Phase|
|HIV||Drug: MGN1703||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Toll-like Receptor 9 Enhancement of Antiviral Immunity in Chronic HIV-1 Infection: a Phase 1b/2a Trial|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||June 1, 2017|
|Actual Study Completion Date :||June 25, 2017|
TLR-9 agonist MGN1703 administered to HIV-1 positive patients on cART
60 mg s.c. twice weekly for 4 weeks
60 mg s.c. twice weekly for 24 weeks
- 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
- 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
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443935
|Department for Infectious Diseases, Aarhus University Hospital|
|Aarhus N, Denmark, 8200|
|Department for Infectious Diseases, Amager and Hvidovre Hospitals|
|Hvidovre, Denmark, 2650|
|Study Chair:||Lars J Østergaard, MD,PhD,DMSc||Department for Infectious Diseases, Aarhus University Hospital, Denmark|
|Responsible Party:||University of Aarhus|
|Other Study ID Numbers:||
|First Posted:||May 14, 2015 Key Record Dates|
|Last Update Posted:||June 29, 2017|
|Last Verified:||April 2015|
Physiological Effects of Drugs