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Monthly HIV prevention pill tested in women – study halted early

NCT ID NCT04644029

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new monthly pill (islatravir) to see if it could prevent HIV infection better than a daily pill in 730 women at high risk. The trial was stopped early, so results are limited. The goal was to offer a more convenient prevention option.

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

730 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2024

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 to 45 years

Sex

Female 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: * Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization. * Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening. * High risk for HIV-1 infection. * Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose. * A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention. Exclusion Criteria: * Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. * Findings of chronic hepatitis B virus (HBV) infection or past HBV. * Current or chronic history of liver disease. * History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer. * Past or current use of cabotegravir, lenacapavir, or any other long-acting HIV prevention product. * Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1. * Expecting to conceive or donate eggs at any time during the study.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

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

HIV-I Human immunodeficiency virus type 1 Prophylaxis

Contacts and locations

Locations

  • Aurum Institute - Rustenburg ( Site 0022)

    Rustenburg, North West, 0299, South Africa

  • Aurum Institute Klerksdorp CRS ( Site 0029)

    Klerksdorp, North West, 2571, South Africa

  • Bronx Prevention Center ICAP ( Site 0062)

    The Bronx, New York, 10451, United States

  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0020)

    Johannesburg, Gauteng, 2092, South Africa

  • KC CARE Health Center-Clinical Trials ( Site 0059)

    Kansas City, Missouri, 64111, United States

  • MU-JHU Care Limited-Clinic ( Site 0041)

    Kampala, 10216, Uganda

  • Madibeng Centre for Research ( Site 0019)

    Brits, North West, 0250, South Africa

  • Maternal Adolescent and Child Health Research (MatCH) ( Site 0025)

    Durban, KwaZulu-Natal, 4001, South Africa

  • MedStar Health Research Institute (MedStar Physician Based R-MedStar Washington Hospital Center ( Si

    Washington D.C., District of Columbia, 20010, United States

  • Orlando Immunology Center ( Site 0068)

    Orlando, Florida, 32803, United States

  • Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0023)

    Johannesburg, Gauteng, 1864, South Africa

  • Ponce De Leon Center Grady Health ( Site 0066)

    Atlanta, Georgia, 30308, United States

  • Prism Health North Texas, Oak Cliff Health Center ( Site 0070)

    Dallas, Texas, 75208, United States

  • Prisma Health Richland Hospital-Clinical Research Unit ( Site 0069)

    Columbia, South Carolina, 29203, United States

  • Qhakaza Mbokodo Research Clinic ( Site 0017)

    Ladysmith, KwaZulu-Natal, 3370, South Africa

  • Rutgers New Jersey Medical School-Clinical Research Center ( Site 0071)

    Newark, New Jersey, 07103, United States

  • SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0030)

    Chatsworth, KwaZulu-Natal, 4092, South Africa

  • Setshaba Research Centre ( Site 0016)

    Pretoria, Gauteng, 0152, South Africa

  • The University of Mississippi Medical Center ( Site 0065)

    Jackson, Mississippi, 39216, United States

  • The University of North Carolina at Chapel Hill-Medicine ( Site 0056)

    Chapel Hill, North Carolina, 27599, United States

  • University of Alabama at Birmingham-UAB Sexual Health Research Clinic (SHRC) ( Site 0064)

    Birmingham, Alabama, 35205, United States

  • University of Miami Miller School of Medicine-Infectious Disease ( Site 0076)

    Miami, Florida, 33136, United States

  • West Virginia University-Department of Medicine ( Site 0061)

    Morgantown, West Virginia, 26506, United States

  • Wits Reproductive Health and HIV Institute (WRHI)-Wits RHI Ward 21 Clinical Research site ( Site 002

    Johannesburg, Gauteng, 2000, South Africa

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