A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: HIV Pre-Exposure Prophylaxis; Human Immunodeficiency Virus (HIV)

Treatments: Drug: Placebo to MK-8527; Drug: MK-8527; Drug: Placebo to FTC/TDF; Drug: FTC/TDF

Study type: Interventional

Funder types: Industry

Identifiers

NCT07044297

8527-011

2025-520610-58-00 (Registry Identifier)

U1111-1317-6239 (Registry Identifier)

MK-8527-011 (Other Identifier)

Details and patient eligibility

About

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 as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
• About the safety of MK-8527 and if people tolerate it

Enrollment: 4,390 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

• Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
• Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
• Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
• 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 anal or cervical cancers
• 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
• Is expecting to donate eggs at any time during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,390 participants in 2 patient groups

MK-8527

Experimental group

Description:

Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to 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.

Treatment:

Drug: FTC/TDF

Drug: Placebo to FTC/TDF

Drug: MK-8527

FTC/TDF

Active Comparator group

Description:

Participants will receive 200 mg FTC/245 mg TDF QD and placebo 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.

Treatment:

Drug: FTC/TDF

Drug: Placebo to MK-8527