A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Last updated: June 26, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Aids And Aids Related Infections

Hiv (Pediatric)

Hiv Infections

Treatment

Placebo matched to FTC/TDF

Emtricitabine/tenofovir disoproxil (FTC/TDF)

Placebo matched to MK-8527

Clinical Study ID

NCT07071623
8527-010
MK-8527-010
  • Ages 16-30
  • Female
  • Accepts Healthy Volunteers

Study Summary

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.

The goals of this study are to learn:

  • If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day

  • About the safety of MK-8527 and if people tolerate it

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negativeHIV-1/HIV-2 test results

  • Has been sexually active (2 vaginal intercourse encounters with cisgender maleindividual(s) within the last 3 months)

  • Was assigned female sex at birth and is cisgender.

  • Weighs ≥35 kg

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has hypersensitivity or other contraindication to any component of the studyinterventions

  • Has evidence of acute or chronic hepatitis B infection

  • Has a history of malignancy within 5 years of screening except for adequatelytreated basal cell or squamous cell skin cancer, or in situ cervical cancer

  • Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention productat any time

  • Is receiving or is anticipated to require any prohibited therapies from 30 daysprior to Day 1 through the study duration

  • Has received an HIV vaccine at any time (ie, through past participation in aninvestigational clinical study) or monoclonal antibodies to HIV within 12 monthsbefore Day 1

Study Design

Total Participants: 4580
Treatment Group(s): 4
Primary Treatment: Placebo matched to FTC/TDF
Phase: 3
Study Start date:
November 10, 2025
Estimated Completion Date:
October 18, 2027

Connect with a study center

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

    Homabay County, Homa Bay County 40222
    Kenya

    Active - Recruiting

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

    Thika, Kiambu County 00202
    Kenya

    Active - Recruiting

  • KEMRI-CMR-RCTP ( Site 0003)

    Nairobi, Kisumu County 00200
    Kenya

    Active - Recruiting

  • Kargeno Research & Policy Hub ( Site 0007)

    Kisumu, 40123
    Kenya

    Active - Recruiting

  • Synergy Biomed Research Institute ( Site 0040)

    East London, Eastern Cape 5241
    South Africa

    Active - Recruiting

  • Foundation For Professional Development ( Site 0031)

    Ndevana, Eastern Cape 5660
    South Africa

    Active - Recruiting

  • Josha Research ( Site 0045)

    Bloemfontein, Free State 9301
    South Africa

    Active - Recruiting

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

    Johannesburg, Gauteng 2092
    South Africa

    Active - Recruiting

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

    Johannesburg, Gauteng 2001
    South Africa

    Active - Recruiting

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

    Johnnesburg, Gauteng 1864
    South Africa

    Active - Recruiting

  • Setshaba Research Centre ( Site 0032)

    Pretoria, Gauteng 0152
    South Africa

    Active - Recruiting

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

    Johannesburg 993800, Gauteng 1085594 2092
    South Africa

    Active - Recruiting

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

    Chatsworth, KwaZulu-Natal 4092
    South Africa

    Active - Recruiting

  • CAPRISA eThekwini Clinical Research Site ( Site 0030)

    Durban, KwaZulu-Natal 4001
    South Africa

    Active - Recruiting

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

    Durban, KwaZulu-Natal 3660
    South Africa

    Active - Recruiting

  • Umlazi Clinical Research Site ( Site 0047)

    Durban, KwaZulu-Natal 4089
    South Africa

    Active - Recruiting

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

    Durban, KwaZulu-Natal 4001
    South Africa

    Active - Recruiting

  • SYNAPSE Research Clinic ( Site 0043)

    Edendale, KwaZulu-Natal 3216
    South Africa

    Active - Recruiting

  • Qhakaza Mbokodo Research Clinic ( Site 0028)

    Ladysmith, KwaZulu-Natal 3370
    South Africa

    Active - Recruiting

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

    Phoenix, KwaZulu-Natal 4068
    South Africa

    Active - Recruiting

  • CAPRISA Vulindlela Clinical Research Site ( Site 0029)

    Pietermaritzburg, KwaZulu-Natal 3231
    South Africa

    Active - Recruiting

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

    Somkhele - Mtubatuba, KwaZulu-Natal 3935
    South Africa

    Active - Recruiting

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

    Verulam, KwaZulu-Natal 4340
    South Africa

    Active - Recruiting

  • CAPRISA eThekwini Clinical Research Site ( Site 0030)

    Durban 1007311, KwaZulu-Natal 972062 4001
    South Africa

    Active - Recruiting

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

    Durban 1007311, KwaZulu-Natal 972062 3660
    South Africa

    Active - Recruiting

  • Umlazi Clinical Research Site ( Site 0047)

    Durban 1007311, KwaZulu-Natal 972062 4089
    South Africa

    Active - Recruiting

  • DTHF Masiphumelele Clinical Research Site ( Site 0023)

    Cape Town, Western Cape 7795
    South Africa

    Active - Recruiting

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

    Cape Town, Western Cape 7781
    South Africa

    Active - Recruiting

  • Vuka Research Clinic ( Site 0025)

    Khayelitsha, Western Cape 7784
    South Africa

    Active - Recruiting

  • DTHF Masiphumelele Clinical Research Site ( Site 0023)

    Cape Town 3369157, Western Cape 1085599 7795
    South Africa

    Active - Recruiting

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

    Entebbe, Central Region 256
    Uganda

    Active - Recruiting

  • Infectious Diseases Institute Kalangala ( Site 0063)

    Kalangala District, Kalangala 30060/+256
    Uganda

    Active - Recruiting

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

    Mityana, District, Mityana 30026/+256
    Uganda

    Active - Recruiting

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

    Entebbe, Wakiso 30006
    Uganda

    Active - Recruiting

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

    Kampala, 10216/+256
    Uganda

    Active - Recruiting

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