ISL

DRUG5 trials

Sponsors

Merck Sharp & Dohme LLC, Gilead Sciences

Conditions

HIV Preexposure ProphylaxisHIV-1 InfectionHuman Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase 2

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Active, not recruitingNCT05052996

Gilead SciencesHIV-1 Infection

Start: 2021-10-05End: 2028-03-01Updated: 2026-02-04

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)

Active, not recruitingNCT06891066

Merck Sharp & Dohme LLCHuman Immunodeficiency Virus Type 1 (HIV-1) Infection

Start: 2025-04-14End: 2031-09-30Target: 150Updated: 2025-10-16

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

RecruitingNCT07266831

Merck Sharp & Dohme LLCHuman Immunodeficiency Virus Type 1 (HIV-1) Infection

Start: 2025-12-18End: 2030-04-03Target: 570Updated: 2026-03-27

Phase 3

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

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)

TerminatedNCT04652700

Merck Sharp & Dohme LLCHIV Preexposure Prophylaxis

Start: 2021-03-15End: 2023-08-04Updated: 2025-01-13

Related Papers

Safety and Tolerability of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Men and Transgender Women Who Have an Elevated Likelihood of HIV-1 Exposure: Results From the IMPOWER-24 Randomized Phase 3 Study

UNC Libraries2026-03-26

Safety and Tolerability of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Men and Transgender Women Who Have an Elevated Likelihood of HIV-1 Exposure: Results From the IMPOWER-24 Randomized Phase 3 Study.

2026-03-14

Once-Weekly Oral Islatravir Plus Lenacapavir Versus Daily Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Persons With HIV-1 : A Phase 2 Randomized Study.

2025-12-23

Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1: results from a randomized trial.

2025-10-01

Pharmacokinetics of islatravir in participants with moderate hepatic impairment

Antimicrobial Agents and Chemotherapy2025-03-05

577. Week 48 Results of a Phase 2 Study Evaluating Once-weekly Oral Islatravir Plus Lenacapavir

Open Forum Infectious Diseases2025-01-293 citations

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