A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
NCT ID: NCT07071623
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4580 participants
INTERVENTIONAL
2025-11-10
2027-10-18
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MK-8527 + Placebo to FTC/TDF
Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
MK-8527
Oral tablet
Placebo matched to FTC/TDF
Placebo oral tablet matched to FTC/TDF
FTC/TDF + Placebo to MK-8527
Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
Emtricitabine/tenofovir disoproxil (FTC/TDF)
Oral tablet
Placebo matched to MK-8527
Placebo oral tablet matched to MK-8527
Interventions
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MK-8527
Oral tablet
Emtricitabine/tenofovir disoproxil (FTC/TDF)
Oral tablet
Placebo matched to MK-8527
Placebo oral tablet matched to MK-8527
Placebo matched to FTC/TDF
Placebo oral tablet matched to FTC/TDF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
30 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Foundation For Professional Development ( Site 0031)
Ndevana, Eastern Cape, South Africa
Josha Research ( Site 0045)
Bloemfontein, Free State, South Africa
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8527-010
Identifier Type: OTHER
Identifier Source: secondary_id
8527-010
Identifier Type: -
Identifier Source: org_study_id