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Monthly HIV prevention pill trial halted Mid-Study

NCT ID NCT04652700

Prevention Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a once-monthly pill called islatravir to prevent HIV infection in cisgender men and transgender women who have sex with men and are at high risk. About 494 participants were enrolled, but the trial was terminated early. The main goal was to check safety and see if the pill could prevent HIV.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

494 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV preexposure prophylaxis

Contacts and locations

Locations

  • Bridge HIV - San Francisco Department of Public Health ( Site 0003)

    San Francisco, California, 94102, United States

  • Center Hospital of the National Center for Global Health and Medicine ( Site 0101)

    Shinjyuku-ku, Tokyo, 162-8655, Japan

  • Central Texas Clinical Research ( Site 0002)

    Austin, Texas, 78705, United States

  • Centro de Referência e Treinamento DST/AIDS ( Site 0351)

    São Paulo, 04121-000, Brazil

  • Chulalongkorn University-Pediatrics ( Site 0051)

    Bangkok, Bangkok, 10330, Thailand

  • Desmond Tutu HIV Foundation ( Site 0202)

    Cape Town, Western Cape, 7925, South Africa

  • Global Research Institute ( Site 0031)

    Los Angeles, California, 90036, United States

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 0056)

    Bangkok, Bangkok, 10330, Thailand

  • Howard Brown Health Center ( Site 0004)

    Chicago, Illinois, 60613, United States

  • Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151)

    Paris, Île-de-France Region, 75010, France

  • Midway Immunology and Research Center ( Site 0014)

    Ft. Pierce, Florida, 34982, United States

  • Orlando Immunology Center ( Site 0010)

    Orlando, Florida, 32803, United States

  • Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203)

    Johannesburg, Gauteng, 1864, South Africa

  • Ponce De Leon Center Grady Health ( Site 0032)

    Atlanta, Georgia, 30308, United States

  • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052

    Chiang Mai, 50200, Thailand

  • Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017)

    Newark, New Jersey, 07103, United States

  • The Crofoot Research Center ( Site 0025)

    Houston, Texas, 77098, United States

  • The GW Medical Faculty Associates-Medicine ( Site 0033)

    Washington D.C., District of Columbia, 20037, United States

  • The University of Mississippi Medical Center ( Site 0012)

    Jackson, Mississippi, 39216, United States

  • The University of North Carolina at Chapel Hill ( Site 0019)

    Chapel Hill, North Carolina, 27599, United States

  • UCLA Center for Clinical AIDS Research and Education ( Site 0011)

    Los Angeles, California, 90035, United States

  • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007)

    Birmingham, Alabama, 35222, United States

  • University of Miami Miller School of Medicine-Infectious Disease ( Site 0029)

    Miami, Florida, 33136, United States

  • Via Libre ( Site 0404)

    Lima, 15001, Peru

  • Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201)

    Johannesburg, Gauteng, 2000, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.