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

Purpose

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

Eligibility

Eligible Ages
Over 16 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: MK-8527
    Oral tablet
  • Drug: FTC/TDF
    Oral tablet
    Other names:
    • Truvada
    • Emtricitabine/Tenofovir Disoproxil Fumarate
  • Drug: Placebo to FTC/TDF
    Placebo tablet matched to FTC/TDF
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.
  • Drug: FTC/TDF
    Oral tablet
    Other names:
    • Truvada
    • Emtricitabine/Tenofovir Disoproxil Fumarate
  • Drug: Placebo to MK-8527
    Placebo tablet matched to MK-8527

Recruiting Locations

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham, Alabama 35222
Contact:
Study Coordinator
205-934-2490

USA Health University Hospitals ( Site 0020)
Mobile, Alabama 36617
Contact:
Study Coordinator
251-471-7000

UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles, California 90035
Contact:
Study Coordinator
310-843-2015

Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco, California 94102
Contact:
Study Coordinator
628-217-7400

Whitman-Walker Institute ( Site 0016)
Washington D.C., District of Columbia 20032
Contact:
Study Coordinator
202-207-2510

University of Miami RAPID Research ( Site 0003)
Miami, Florida 33136
Contact:
Study Coordinator
305-243-4378

Orlando Immunology Center ( Site 0021)
Orlando, Florida 32803
Contact:
Study Coordinator
407-374-0220

Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur, Georgia 30030
Contact:
Study Coordinator
404-712-1370

University of Illinois Chicago ( Site 0027)
Chicago, Illinois 60612
Contact:
Study Coordinator
312-864-4578

University Medical Center New Orleans ( Site 0024)
New Orleans, Louisiana 70112
Contact:
Study Coordinator
504-568-7740

Open Arms Healthcare Center ( Site 0025)
Jackson, Mississippi 39202
Contact:
Study Coordinator
601-500-7660

Rutgers New Jersey Medical School ( Site 0010)
Newark, New Jersey 07103
Contact:
Study Coordinator
848-445-4357

Montefiore Medical Center ( Site 0017)
The Bronx, New York 10467
Contact:
Study Coordinator
718-920-2229

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill, North Carolina 27514-7064
Contact:
Study Coordinator
919-843-0720

Regional Center for Infectious Diseases ( Site 0018)
Greensboro, North Carolina 27401
Contact:
Study Coordinator
336-832-3275

Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia, Pennsylvania 19107
Contact:
Study Coordinator
214-985-4448

University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh, Pennsylvania 15213
Contact:
Study Coordinator
412-648-9636

Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia, South Carolina 29203
Contact:
Study Coordinator
803-434-7703

St. Jude Children's Research Hospital ( Site 0026)
Memphis, Tennessee 38105
Contact:
Study Coordinator
901-595-3300

Meharry Medical College ( Site 0013)
Nashville, Tennessee 37208
Contact:
Study Coordinator
615-327-6353

Central Texas Clinical Research ( Site 0014)
Austin, Texas 78705
Contact:
Study Coordinator
512-496-9899

Saint Hope Foundation, Inc. ( Site 0015)
Bellaire, Texas 77401
Contact:
Study Coordinator
713-839-7111

Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle, Washington 98104
Contact:
Study Coordinator
206-667-2300

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com