Trial update: Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Trial Update

The Gilead-sponsored, Merck-partnered Ph2 study investigating the efficacy of QW oral ISL+LEN has revised its study protocol to use a lower 2 mg dose of ISL (NCT05052996). Previously, a 40 mg loading dose of ISL was delivered on days 1 and 2 followed by a weekly 20 mg maintenance dose, whereas the amended protocol will only use 2 mg ISL on day 1 and a weekly 2 mg maintenance dose thereafter (12/21).

This protocol update follows discussions with the FDA, disclosed in a Merck PR and in its Q3 2022 EC, suggesting that the study may resume in the near future.

Additional information to the following link: https://clinicaltrials.gov/ct2/show/NCT05052996?term=islatravir