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

Not Applicable

Not yet recruiting

• Conditions: Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis
• Interventions: Drug: MK-8527; Drug: FTC/TDF; Drug: Placebo to MK-8527; Drug: Placebo to FTC/TDF

• Registration Number: NCT07044297
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Study First Posted: 2025-06-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Study Start: 2025-07-31
• Primary Completion: 2027-10-20
• Study Completion: 2027-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4390

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-8527	MK-8527	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.
MK-8527	FTC/TDF	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.
MK-8527	Placebo to FTC/TDF	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.
FTC/TDF	FTC/TDF	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.
FTC/TDF	Placebo to MK-8527	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection	Up to approximately 2 years	The number of participants with adjudicated HIV-1 infection will be determined.
Number of Participants Who Experience At Least One Adverse Event (AE)	Up to approximately 2 years	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be reported.
Number of Participants Who Discontinue Study Intervention Due to an AE	Up to approximately 2 years	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be reported.