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Doravirine-Islatravir (Idvynso)
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Common TitleMK-8591A-051 Industry
Official Title 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
Phase Phase III
ClinicalTrials.gov NCT05631093
Treatments
Doravirine-Islatravir
Doravirine-Islatravir
Tradename:IdvynsoClass:Single-Tablet RegimensFunding
IndustryMerck Sharp & Dohme
References
- Orkin C, Mngqibisa R, Velez JD, et al. Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial. Lancet. 2026;407:599-610.
Common TitleMK-8591A-052 Industry
Official Title 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)
Phase Phase III
ClinicalTrials.gov NCT05630755
Treatments
Doravirine-Islatravir
Doravirine-Islatravir
Tradename:IdvynsoClass:Single-Tablet RegimensFunding
IndustryMerck Sharp & Dohme
References
- Colson AE, Mills AM, Ramgopal MN, et al. Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial. Lancet. 2026;407:611-21.
Common TitleMK-8591A-053 Industry
Official Title 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
Phase Phase III
ClinicalTrials.gov NCT05705349
Treatments
Doravirine-Islatravir
Doravirine-Islatravir
Tradename:IdvynsoClass:Single-Tablet RegimensFunding
IndustryMerck Sharp & Dohme
References
- Rockstroh JK, Kassim S, Paredes R, et al. Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial. Lancet HIV. 2026;13:e440-e451.