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Monthly HIV prevention pill could replace daily dose

NCT ID NCT07071623

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 12 times

Summary

This phase 3 trial tests MK-8527, a once-monthly oral pill, to prevent HIV-1 infection in women. About 4580 HIV-negative women will take either MK-8527 monthly or a daily PrEP pill (Truvada) to see which works better and is safer. The goal is to offer a more convenient prevention option.

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 (oral tablet)
What this could lead to
If successful, this could offer a more convenient once-monthly pill for HIV prevention, potentially improving adherence and reducing infection rates.
What could go wrong
This is a phase 3 trial, but results may show MK-8527 is less effective or has more side effects than daily PrEP. Long-term safety and real-world effectiveness are still unknown.

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

About 4,580 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

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 30 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: The main inclusion criteria include but are not limited to the following: * Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results * Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months) * Was assigned female sex at birth and is cisgender. * Weighs ≥35 kg Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has hypersensitivity or other contraindication to any component of the study interventions * Has evidence of acute or chronic hepatitis B infection * Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time * Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration * Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1

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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 pre-exposure prophylaxis Human immunodeficiency virus (HIV)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)

    ACTIVE_NOT_RECRUITING

    Somkhele - Mtubatuba, KwaZulu-Natal, 3935, South Africa

  • CAPRISA Vulindlela Clinical Research Site ( Site 0029)

    RECRUITING

    Pietermaritzburg, KwaZulu-Natal, 3231, South Africa

  • CAPRISA eThekwini Clinical Research Site ( Site 0030)

    RECRUITING

    Durban, KwaZulu-Natal, 4001, South Africa

  • DTHF Masiphumelele Clinical Research Site ( Site 0023)

    RECRUITING

    Cape Town, Western Cape, 7975, South Africa

  • Desmond Tutu Health Foundation. Philippi Village ( Site 0024)

    RECRUITING

    Cape Town, Western Cape, 7781, South Africa

  • Foundation For Professional Development ( Site 0031)

    ACTIVE_NOT_RECRUITING

    Ndevana, Eastern Cape, 5660, South Africa

  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)

    ACTIVE_NOT_RECRUITING

    Johannesburg, Gauteng, 2092, South Africa

  • Infectious Diseases Institute Kalangala ( Site 0063)

    RECRUITING

    Kalangala District, Kalangala, 30060, Uganda

  • Josha Research ( Site 0045)

    ACTIVE_NOT_RECRUITING

    Bloemfontein, Free State, 9301, South Africa

  • KEMRI-CMR-RCTP ( Site 0003)

    RECRUITING

    Nairobi, Kisumu County, 00200, Kenya

  • Kargeno Research & Policy Hub ( Site 0007)

    RECRUITING

    Kisumu, 40123, Kenya

  • MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064)

    RECRUITING

    Entebbe, Central Region, 256, Uganda

  • MU-JHU Research Collaboration - Kampala ( Site 0062)

    RECRUITING

    Kampala, 10216/+256, Uganda

  • MU-JHU Research Collaboration - Mityana ( Site 0061)

    RECRUITING

    Mityana, District, Mityana, 30026/+256, Uganda

  • Partners in Health and Research Development (PHRD) ( Site 0002)

    ACTIVE_NOT_RECRUITING

    Thika, Kiambu County, 00202, Kenya

  • Perinatal HIV Research Unit (PHRU) ( Site 0033)

    RECRUITING

    Johnnesburg, Gauteng, 1864, South Africa

  • Qhakaza Mbokodo Research Clinic ( Site 0028)

    RECRUITING

    Ladysmith, KwaZulu-Natal, 3370, South Africa

  • SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)

    ACTIVE_NOT_RECRUITING

    Durban, KwaZulu-Natal, 3660, South Africa

  • SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)

    ACTIVE_NOT_RECRUITING

    Chatsworth, KwaZulu-Natal, 4092, South Africa

  • SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)

    RECRUITING

    Phoenix, KwaZulu-Natal, 4068, South Africa

  • SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)

    RECRUITING

    Verulam, KwaZulu-Natal, 4340, South Africa

  • SYNAPSE Research Clinic ( Site 0043)

    RECRUITING

    Edendale, KwaZulu-Natal, 3216, South Africa

  • Setshaba Research Centre ( Site 0032)

    RECRUITING

    Pretoria, Gauteng, 0152, South Africa

  • Synergy Biomed Research Institute ( Site 0040)

    RECRUITING

    East London, Eastern Cape, 5241, South Africa

  • UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)

    RECRUITING

    Entebbe, Wakiso, 30006, Uganda

  • UW - KNH; Rachuonyo County Hospital ( Site 0006)

    RECRUITING

    Homabay County, Homa Bay County, 40222, Kenya

  • Umlazi Clinical Research Site ( Site 0047)

    RECRUITING

    Durban, KwaZulu-Natal, 4089, South Africa

  • Vuka Research Clinic ( Site 0025)

    ACTIVE_NOT_RECRUITING

    Khayelitsha, Western Cape, 7784, South Africa

  • Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)

    RECRUITING

    Durban, KwaZulu-Natal, 4001, South Africa

  • Wits RHI Ward 21 Clinical Research site ( Site 0022)

    RECRUITING

    Johannesburg, Gauteng, 2001, South Africa

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