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Monthly HIV prevention pill could replace daily dose

NCT ID NCT07071623

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

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 8 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.

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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)

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    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)

    ACTIVE_NOT_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)

    RECRUITING

    Johannesburg, Gauteng, 2092, South Africa

  • Infectious Diseases Institute Kalangala ( Site 0063)

    RECRUITING

    Kalangala District, Kalangala, 30060/+256, Uganda

  • Josha Research ( Site 0045)

    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)

    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)

    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)

    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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