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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: HIV Preexposure Prophylaxis

In brief

The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.

Key facts

Study ID: NCT04652700
Run by: Merck Sharp & Dohme LLC
People needed: 494
Starts: 2021-03-15
Expected to finish: 2023-08-04
Last updated by the study team: 2026-05-05

Who can join

Age: 16 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Has confirmed Human Immunodeficiency Virus (HIV) uninfected based on negative HIV-1/HIV-2 test result before randomization
Is sexually active with male or transgender women (TGW) partners defined as having anal sexual intercourse with a man or TGW at least once in the past month
Is at high risk for sexually acquiring HIV-1 infection based on self-report of at least 1 of the following: a) Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship b) More than 5 partners (anal intercourse) in the 6 months prior to screening c) Any unprescribed stimulant drug use in the 6 months prior to screening d) Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening
Participants 16 or 17 years of age must weigh ≥35 kg. Enrollment for 16- to 17-year-old participants will begin only after completion of the Sentinel Cohort IA and review of IA results by the external data monitoring committee (eDMC)
Has no plans to relocate or travel away from the site for ≥4 consecutive weeks during study participation

You may not qualify if…

Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator
Has chronic HBV infection or past HBV infection which could indicate risk for Hepatitis B reactivation
Has known current or chronic history of liver disease or known hepatic or biliary abnormalities, unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction
Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer or in situ anal cancers
Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to enroll
Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
Is currently receiving or is anticipated to require any prohibited therapies outlined in the study from 30 days prior to Day 1 through the duration of the study
Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device, within 30 days prior to Day 1 through the duration of the study
Has exclusionary laboratory values within 45 days prior to Day 1

Where it is running

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007) — Birmingham, Alabama, United States
UCLA Center for Clinical AIDS Research and Education ( Site 0011) — Los Angeles, California, United States
Global Research Institute ( Site 0031) — Los Angeles, California, United States
Bridge HIV - San Francisco Department of Public Health ( Site 0003) — San Francisco, California, United States
The GW Medical Faculty Associates-Medicine ( Site 0033) — Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 0014) — Ft. Pierce, Florida, United States
University of Miami Miller School of Medicine-Infectious Disease ( Site 0029) — Miami, Florida, United States
Orlando Immunology Center ( Site 0010) — Orlando, Florida, United States
Ponce De Leon Center Grady Health ( Site 0032) — Atlanta, Georgia, United States
Howard Brown Health Center ( Site 0004) — Chicago, Illinois, United States
The University of Mississippi Medical Center ( Site 0012) — Jackson, Mississippi, United States
Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017) — Newark, New Jersey, United States
The University of North Carolina at Chapel Hill ( Site 0019) — Chapel Hill, North Carolina, United States
Central Texas Clinical Research ( Site 0002) — Austin, Texas, United States
The Crofoot Research Center ( Site 0025) — Houston, Texas, United States
Centro de Referência e Treinamento DST/AIDS ( Site 0351) — São Paulo, Brazil
Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151) — Paris, Île-de-France Region, France
Center Hospital of the National Center for Global Health and Medicine ( Site 0101) — Shinjyuku-ku, Tokyo, Japan
Via Libre ( Site 0404) — Lima, Peru
Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203) — Johannesburg, Gauteng, South Africa
Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201) — Johannesburg, Gauteng, South Africa
Desmond Tutu HIV Foundation ( Site 0202) — Cape Town, Western Cape, South Africa
Chulalongkorn University-Pediatrics ( Site 0051) — Bangkok, Bangkok, Thailand
HIV Netherlands Australia Thailand Research Collaboration ( Site 0056) — Bangkok, Bangkok, Thailand
Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052 — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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