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DOR/ISL

DRUG10 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

HIV InfectionHIV-1 InfectionHealthy

Phase 1

A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061)
CompletedNCT07086079
Merck Sharp & Dohme LLCHealthy
Start: 2025-09-26End: 2026-02-04Updated: 2026-02-20

Phase 2

Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
CompletedNCT04295772
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2020-11-26End: 2023-01-25Updated: 2024-01-31

Phase 3

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
CompletedNCT04223791
Merck Sharp & Dohme LLCHIV Infection
Start: 2020-02-18End: 2025-02-27Updated: 2026-03-27
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
CompletedNCT04223778
Merck Sharp & Dohme LLCHIV Infection
Start: 2020-02-18End: 2024-08-26Updated: 2026-02-18
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
CompletedNCT04233216
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2020-03-18End: 2023-11-01Updated: 2024-12-27
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
CompletedNCT04233879
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2020-02-28End: 2025-01-29Updated: 2026-01-28
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
Active, not recruitingNCT05631093
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2023-02-20End: 2028-07-11Updated: 2025-11-21
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
Active, not recruitingNCT05630755
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2023-02-17End: 2028-08-04Updated: 2025-11-18
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Active, not recruitingNCT05705349
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2023-03-08End: 2029-08-05Updated: 2025-10-23
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
Active, not recruitingNCT05766501
Merck Sharp & Dohme LLCHIV Infection
Start: 2023-03-17End: 2028-09-06Updated: 2025-12-17

Related Papers

P-377. Efficacy and Safety by Age After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results from Two Phase 3 Randomized, Active-Controlled Studies in Adults Living with HIV-1
Open Forum Infectious Diseases2026-01-01
P-389. Switching to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily Maintains Viral Suppression Through Week 48 in the Presence of Archived NNRTI Resistance-Associated Mutations or M184I/V in Proviral DNA
Open Forum Infectious Diseases2026-01-01
P-369. Safety and Efficacy of Doravirine/Islatravir (DOR/ISL) 100/0.25 mg Once Daily (QD) after ISL Dose Reduction from 0.75 mg: Week 48 Results from an Open-Label Phase 3 Study
Open Forum Infectious Diseases2026-01-01
P-364. Efficacy and Safety by Sex Assigned at Birth After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results from Two Phase 3 Randomized, Active-Controlled Studies in Adults Living with HIV-1
Open Forum Infectious Diseases2026-01-01
Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1: results from a randomized trial.
2025-10-01
Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial HIV-1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial
Clinical Infectious Diseases2025-03-132 citations
Pharmacokinetics of islatravir in participants with moderate hepatic impairment
Antimicrobial Agents and Chemotherapy2025-03-05
Switch to fixed-dose doravirine (100 mg) with islatravir (0·75 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial.
2024-05-0812 citations
Switch to fixed-dose doravirine (100 mg) with islatravir (0·75 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial.
2024-05-0811 citations