Placebo to BIC/FTC/TAF

DRUG6 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

HIV InfectionHIV-1 Infection

Phase 2

Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

CompletedNCT04564547

Merck Sharp & Dohme LLCHIV-1 Infection

Start: 2021-03-09End: 2025-01-30Updated: 2026-01-26

A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults with HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily

CompletedCTIS2024-511041-19-00

Merck Sharp & Dohme LLCHIV-1 Infection

Start: 2021-04-06End: 2025-01-28Target: 48Updated: 2025-01-29

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

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 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

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-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

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