Islatravir

DRUG13 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

HIVHIV-1 InfectionHIV-IHealthyHuman Immunodeficiency VirusHuman Immunodeficiency Virus (HIV) InfectionHuman Immunodeficiency Virus (HIV) InfectionsHuman Immunodeficiency Virus Type 1

Phase 1

Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

CompletedNCT04303156

Merck Sharp & Dohme LLCHuman Immunodeficiency Virus (HIV) Infection

Start: 2020-06-18End: 2020-10-19Updated: 2021-10-28

Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)

CompletedNCT04515641

Merck Sharp & Dohme LLCHuman Immunodeficiency Virus (HIV) Infection

Start: 2020-11-05End: 2021-09-13Updated: 2025-07-17

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

CompletedNCT04568603

Merck Sharp & Dohme LLCHIV-1 Infection

Start: 2020-10-16End: 2021-07-09Updated: 2025-01-28

A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)

CompletedNCT06619678

Merck Sharp & Dohme LLCHealthy

Start: 2024-01-17End: 2024-06-23Updated: 2024-10-01

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)

CompletedNCT06719570

Merck Sharp & Dohme LLCHealthy

Start: 2024-01-23End: 2024-03-15Updated: 2024-12-06

Phase 2

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

CompletedNCT03272347

Merck Sharp & Dohme LLCHIV-1 Infection

Start: 2017-11-27End: 2022-03-09Updated: 2023-03-29

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)

CompletedNCT04003103

Merck Sharp & Dohme LLCHIV-1 Infection

Start: 2019-09-19End: 2022-11-24Updated: 2025-07-18

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

Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)

WithdrawnNCT05115838

Merck Sharp & Dohme LLCHIV, Human Immunodeficiency Virus

Start: 2024-01-04End: 2025-10-02Updated: 2023-11-24

A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)

WithdrawnNCT05130086

Merck Sharp & Dohme LLCHuman Immunodeficiency Virus (HIV) Infections

Start: 2022-10-17End: 2024-03-25Updated: 2022-10-17

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

A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV 1

Not yet recruitingCTIS2025-522519-40-00

Merck Sharp & Dohme LLCHIV

Target: 35Updated: 2026-02-16

Phase 3

Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

TerminatedNCT04644029

Merck Sharp & Dohme LLCHIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis

Start: 2021-02-24End: 2024-06-11Updated: 2026-02-04

Related Papers

Islatravir distribution in plasma, peripheral blood mononuclear cells, and mucosal tissues after monthly oral dosing.

2026-03-06

Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1.

2025-11-011 citations

Brief Report: Exploratory Substudy of a Phase 2 Trial to Evaluate the Pharmacokinetic Effect of Once-Monthly Islatravir on Long-Acting Reversible Contraceptives

JAIDS Journal of Acquired Immune Deficiency Syndromes2025-04-22

Pharmacokinetics of islatravir in participants with moderate hepatic impairment

Antimicrobial Agents and Chemotherapy2025-03-05

A Phase 1 Study to Evaluate the Pharmacokinetic Drug‐Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy

Clinical Pharmacology in Drug Development2024-12-08

Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency.

2022-11-0812 citations

Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine

JAIDS Journal of Acquired Immune Deficiency Syndromes2021-12-0824 citations

Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial.

2021-05-1433 citations