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Monthly pill could revolutionize HIV prevention

NCT ID NCT06045507

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental oral drug called MK-8527, taken once a month, to see if it is safe and how it works in the body for HIV prevention. 352 HIV-negative adults at low risk for infection participated. The main goals were to check for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-8527 (an experimental oral drug taken once a month)
What this could lead to
If successful, this could lead to a convenient once-monthly pill to prevent HIV infection, offering an alternative to daily PrEP.
What could go wrong
This is an early-phase trial focused on safety and drug levels, not yet on effectiveness. The drug may not work as hoped or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

352 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

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

18 to 65 years

Sex

Anyone

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: * Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization * Has low-risk of HIV infection * Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse Exclusion Criteria: * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid \[RNA\]) * Prior use of MK-8527 or islatravir (MK-8591)

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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 HIV pre-exposure prophylaxis

Contacts and locations

Locations

  • Albuquerque Clinical Trials, Inc. ( Site 0044)

    Albuquerque, New Mexico, 87102, United States

  • Bridge HIV- San Francisco Department of Public Health ( Site 0042)

    San Francisco, California, 94102, United States

  • Community Medical Care Center ( Site 0056)

    Immokalee, Florida, 34142, United States

  • Desmond Tutu Health Foundation ( Site 0021)

    Cape Town, Western Cape, 7925, South Africa

  • Fenway Health ( Site 0043)

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)

    Seattle, Washington, 98104, United States

  • Hadassah Medical Center ( Site 0002)

    Jerusalem, 9112001, Israel

  • Helen Joseph Hospital ( Site 0024)

    Johannesburg, Gauteng, 2092, South Africa

  • Josha Research ( Site 0023)

    Bloemfontein, Free State, 9301, South Africa

  • Prism Health North Texas, Oak Cliff Health Center ( Site 0045)

    Dallas, Texas, 75208, United States

  • Qhakaza Mbokodo Research Clinic ( Site 0026)

    Ladysmith, KwaZulu-Natal, 3370, South Africa

  • Rambam Health Care Campus ( Site 0003)

    Haifa, 3109601, Israel

  • Sheba Medical Center ( Site 0001)

    Ramat Gan, 5265601, Israel

  • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)

    Pittsburgh, Pennsylvania, 15213, United States

  • Velocity Clinical Research Rockville ( Site 0048)

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research, Hallandale Beach ( Site 0052)

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research, North Hollywood ( Site 0054)

    North Hollywood, California, 91606, United States

  • Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)

    Johannesburg, Gauteng, 2000, South Africa

More trials for these conditions

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