#Mk dpi shift exchange trial

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” said Dr. Investigators have been informed of these actions.

No new participants will be screened or randomized in DOR/ISL studies for treatment during the partial clinical hold. Additionally, participants in studies of DOR/ISL who were started on treatment will continue to receive study medication (partial clinical hold). Participants in the PrEP studies will be offered approved, once-daily, oral PrEP.

Participants who are currently receiving islatravir as part of the studies for PrEP, including oral and implant formulations, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug CD4+ T-cell and total lymphocyte counts will be monitored for recovery (full clinical hold). With the FDA’s clinical hold, no new studies may be initiated.

#Mk dpi shift exchange trial

As previously announced, Merck has stopped dosing in the Phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507 (MK-8591-013) and paused enrollment in the once-monthly Phase 3 PrEP studies, (MK-8591-022 and MK-8591-024) (see announcements here and here). The FDA’s clinical hold is based on previously announced observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving islatravir in clinical studies. Food and Drug Administration (FDA) has placed clinical holds on the investigational new drug applications (INDs) for the oral and implant formulations of islatravir (MK-8591) for HIV-1 pre-exposure prophylaxis (PrEP) the injectable formulation of islatravir for HIV-1 treatment and prophylaxis and the oral doravirine/islatravir (DOR/ISL) HIV-1 once-daily treatment. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S.