Recruiting

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07044297

Conditions

Human Immunodeficiency Virus (HIV)

HIV Pre-Exposure Prophylaxis

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

MK-8527

FTC/TDF

Placebo to MK-8527

Placebo to FTC/TDF

Study Details

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

Conditions

Human Immunodeficiency Virus (HIV)

HIV Pre-Exposure Prophylaxis

Study ID

NCT07044297

Start date

Jul 31, 2025

Status verified date

Aug, 2026

Completion date

Jul 22, 2027

Anticipated

Primary completion date

Jul 22, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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

Enrollment

4390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

MK-8527

Oral tablet

FTC/TDF

Oral tablet

Placebo to MK-8527

Placebo tablet matched to MK-8527

Placebo to FTC/TDF

Placebo tablet matched to FTC/TDF

Primary outcome measure

Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection [ Time Frame: Up to approximately 2 years ]
Number of Participants Who Experience At Least One Adverse Event (AE) [ Time Frame: Up to approximately 2 years ]
Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)

Recruiting

Birmingham, Alabama, United States, 35222

Contacts

Study Coordinator

205-934-2490

USA Health University Hospitals ( Site 0020)

Recruiting

Mobile, Alabama, United States, 36617

Contacts

Study Coordinator

251-471-7000

UCLA Center for Clinical AIDS Research and Education ( Site 0004)

Recruiting

Los Angeles, California, United States, 90035

Contacts

Study Coordinator

310-843-2015

Bridge HIV - San Francisco Department of Public Health ( Site 0001)

Recruiting

San Francisco, California, United States, 94102

Contacts

Study Coordinator

628-217-7400

Whitman-Walker Institute ( Site 0016)

Recruiting

Washington D.C., District of Columbia, United States, 20032

Contacts

Study Coordinator

202-207-2510

University of Miami RAPID Research ( Site 0003)

Recruiting

Miami, Florida, United States, 33136

Contacts

Study Coordinator

305-243-4378

Orlando Immunology Center ( Site 0021)

Recruiting

Orlando, Florida, United States, 32803

Contacts

Study Coordinator

407-374-0220

Hope Clinic of the Emory Vaccine Center ( Site 0009)

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Study Coordinator

404-712-1370

University of Illinois Chicago ( Site 0027)

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Study Coordinator

312-864-4578

University Medical Center New Orleans ( Site 0024)

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Study Coordinator

504-568-7740

Open Arms Healthcare Center ( Site 0025)

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Study Coordinator

601-500-7660

Rutgers New Jersey Medical School ( Site 0010)

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Study Coordinator

848-445-4357

Montefiore Medical Center ( Site 0017)

Recruiting

The Bronx, New York, United States, 10467

Contacts

Study Coordinator

718-920-2229

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)

Recruiting

Chapel Hill, North Carolina, United States, 27514-7064

Contacts

Study Coordinator

919-843-0720

Regional Center for Infectious Diseases ( Site 0018)

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Study Coordinator

336-832-3275

Philadelphia Fight Community Health Centers ( Site 0011)

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Coordinator

214-985-4448

University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Study Coordinator

412-648-9636

Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Study Coordinator

803-434-7703

St. Jude Children's Research Hospital ( Site 0026)

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Study Coordinator

901-595-3300

Meharry Medical College ( Site 0013)

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Study Coordinator

615-327-6353

Central Texas Clinical Research ( Site 0014)

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

512-496-9899

Saint Hope Foundation, Inc. ( Site 0015)

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Study Coordinator

713-839-7111

Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)

Recruiting

Seattle, Washington, United States, 98104

Contacts

Study Coordinator

206-667-2300

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-14.