13 completed, 3 active not recruiting, 2 terminated, 2 withdrawn. 8 Phase 2, 7 Phase 1, 7 Phase 3.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) ISL, ULO, BIC/FTC/TAF - Human Immunodeficiency Virus Type 1 (HIV-1) Infection Phase 2 / Phase 3 Recruiting 570 2025-12-18 2026-11-04 A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060) ISL, ULO, BIC/FTC/TAF - Human Immunodeficiency Virus Type 1 (HIV-1) Infection Phase 2 Active not recruiting 150 2025-04-14 2025-10-16 A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058) Islatravir (ISL), Lamivudine (3TC) - Healthy Phase 1 Completed 20 2024-02-07 2025-02-06 A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055) MK-8591A, Islatravir, Doravine - Healthy Phase 1 Completed 24 2024-01-23 2024-12-06 A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016) MK-8507, Islatravir - Healthy Phase 1 Completed 36 2024-01-17 2026-11-10 Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043) Islatravir, Placebo - Human Immunodeficiency Virus, HIV Phase 2 Withdrawn 2024-01-04 2023-11-24 A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in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) DOR/ISL - HIV Infection Phase 3 Active not recruiting 641 2023-03-17 2025-12-17 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) DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF - HIV-1 Infection Phase 3 Active not recruiting 514 2023-02-17 2025-11-18 A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035) Islatravir - Human Immunodeficiency Virus (HIV) Infections Phase 2 Withdrawn 2022-10-17 2022-10-17 Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024) ISL, FTC/TDF, FTC/TAF - HIV Preexposure Prophylaxis Phase 3 Terminated 494 2021-03-15 2026-05-05 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] Islatravir, Ulonivirine, BIC/FTC/TAF - HIV-1 Infection Phase 2 Completed 161 2021-03-09 2026-01-26 Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022) Islatravir, Placebo to FTC/TDF, FTC/TDF - HIV-I, Human Immunodeficiency Virus Type 1 Phase 3 Terminated 730 2021-02-24 2026-02-04 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) DOR/ISL - HIV-1 Infection Phase 2 Completed 42 2020-11-26 2024-01-31 Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030) Islatravir - Human Immunodeficiency Virus (HIV) Infection Phase 1 Completed 12 2020-11-05 2025-07-17 Islatravir and Methadone Pharmacokinetics (MK-8591-029) Islatravir - HIV-1 Infection Phase 1 Completed 14 2020-10-16 2025-01-28 Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026) Islatravir - Human Immunodeficiency Virus (HIV) Infection Phase 1 Completed 12 2020-06-18 2021-10-28 Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) ISL, DOR, DOR/ISL - HIV-1 Infection Phase 3 Completed 35 2020-03-18 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) DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF - HIV-1 Infection Phase 3 Completed 599 2020-02-28 2026-06-03 Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016) Islatravir, Placebo - HIV-1 Infection Phase 2 Completed 242 2019-09-19 2025-07-18 Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) Islatravir, Placebo to Islatravir, Doravirine - HIV-1 Infection Phase 2 Completed 123 2017-11-27 2023-03-29
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Conditions studied Acquired Immunodeficiency Syndrome (7) · Infections (3) · HIV Infections (1)
Sponsors Merck Sharp & Dohme LLC (21)
Countries United States (18) · South Africa (8) · Chile (6) · France (6) · Japan (5) · Australia (4) · Canada (4) · Israel (4) · United Kingdom (4) · Argentina (3) · Colombia (3) · Germany (3) · Italy (3) · Puerto Rico (3) · Russia (3)
Results publications PMID 42213454 , PMID 31911147 , PMID 33540481 , PMID 34000227 , PMID 35972855 , PMID 36346229 , PMID 39648614 , PMID 40042304 , PMID 40079835 , PMID 40260892 , PMID 40327547 , PMID 41037024 , PMID 41654375 , PMID 41789892 , PMID 41830344 , PMID 42847999
NIH funding 2019 (4) , 2014 (1) , 2017 (1) , 2025 (1)