A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy)
The objective of this study is to evaluate the antiviral effectiveness and safety of Doravirine/Islatravir compared to Biktarvy.
You may be eligible to take part in this study if you are at least 18 years of age with HIV-1 infection, are taking Biktarvy, and have had an undetectable HIV viral load for at least three months.
The study team will discuss other criteria with you.
People in this study will be placed into 1 of 2 groups:
- Group 1 will get a combination pill of islatravir and doravirine plus a placebo pill which looks like Biktarvy.
- Group 2 will get Biktarvy plus a placebo pill which looks like islatravir/doravirine.
The placebo pills do not have active ingredients.
You have a 2 in 3 chance of being put in Group 1 and a 1 in 3 chance of being put in Group 2. You and the study team will not know which group you are in.
Participants will remain on their assigned treatment for 96 weeks.
Study Sponsor: Merck Sharp & Dohme LLC
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