Trial update: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed

Trial Update

Merck has initiated two new Ph3 switch trials of DOR/ISL (100 mg/0.25 mg) from SOC ART and BIC/F/TAF:

• • The first trial is investigating the efficacy, safety, and tolerability of switching to DOR/ISL from SOC ART in VS participants (NCT05631093). The study aims to start on February 20, 2023, with a PCD set for October 4, 2024 (11/30).

  • The second trial is investigating the efficacy, safety and tolerability of switching to DOR/ISL from BIC/F/TAF in VS participants (NCT05630755). The study aims to start on February 28, 2023, with a PCD set for September 16, 2024 (11/30).

  • Following DOR/ISL (100 mg/0.75 mg) trial discontinuation, both trials measure CD4+ T-cell count as a secondary outcome

Additional information to the following link: 

https://clinicaltrials.gov/ct2/show/NCT05631093?term=doravirine

https://clinicaltrials.gov/ct2/show/NCT05630755?term=doravirine