Two new Phase 3 studies began enrolling participants this month:
MK-8591A-051 A Phase 3, Randomized, Active-Controlled, Open-Label 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 Antiretroviral Therapy
MK-8591A-052 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 (BIC/FTC/TAF)
The following new Phase 3 studies are expected to begin enrollment in March:
MK-8591A-P053 A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
MK-8591A-P054 A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once-Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) Once-Daily in a Phase 3 Clinical Study
Certain study participants currently enrolled in prior DOR/ISL studies (Protocols 018, 020 and 033), which evaluated once-daily DOR/ISL 100/0.75 mg in treatment-naïve and virologically suppressed participants, will have the option of transitioning to study P054 evaluating once-daily DOR/ISL 100/0.25 mg as a potential fixed-dose combination, two-drug regimen.
Select Merck abstracts for islatravir at the Conference on Retroviruses and Opportunistic Infections 2023 include:
Switch to DOR/ISL (100/0.75MG) QD From B/F/TAF: Week 48 Results From a Phase 3 Trial. Late-breaker oral presentation: 197. Mills, A, et al.
Switch to DOR/ISL (100/0.75MG) QD: Week 48 Results From An Open-label Phase 3 Trial. Late-breaker oral presentation: 196. Molina, J-M, et al.
Effect of Islatravir on Total Lymphocyte and Lymphocyte Subset Counts. Oral presentation: 192. Squires, K, et al.
Modeling To Optimize Islatravir QW Dose in HIV Virologically Suppressed PWH. Late-breaker poster: 497. Vargo, R, et al.
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