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