TEACH study (indication HIV)

TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase I/IIa trial to evaluate lefitolimod (MGN1703) in HIV positive patients. In the first phase of the study, 15 participants received four weeks of lefitolimod therapy (60 mg s.c. twice weekly). The extension phase includes 15 patients, too, who are treated for six months with lefitolimod. During the treatment period, each participant is closely monitored for safety and therapeutic effects of the drug. Aarhus University Hospital, Denmark is conducting the trial in two hospital centers in Denmark, for which it received funding from the American Foundation for AIDS research (amfAR). MOLOGEN is providing the Immune Surveillance Reactivator (ISR) lefitolimod. In June 2016, patient recruitment started for the extension phase. Results are expected to be delivered in the mid-2017.

The primary endpoint of the first study treatment phase is the change in proportions of activated natural killer cells in patients. Secondary study endpoints include, among others, a collection of safety, virological, immunological and pharmacodynamic data. In the extension phase the change in HIV-DNA in circulating T cells will be assessed as primary endpoint. Main secondary endpoints are – besides safety evaluation – changes of functional immune parameters.