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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
Birmingham, Alabama 35222
Study Coordinator
205-934-2490
Mobile, Alabama 36617
Study Coordinator
251-471-7000
Los Angeles, California 90035
Study Coordinator
310-843-2015
San Francisco, California 94102
Study Coordinator
628-217-7400
Washington D.C., District of Columbia 20032
Study Coordinator
202-207-2510
Miami, Florida 33136
Study Coordinator
305-243-4378
Orlando, Florida 32803
Study Coordinator
407-374-0220
Decatur, Georgia 30030
Study Coordinator
404-712-1370
Chicago, Illinois 60612
Study Coordinator
312-864-4578
New Orleans, Louisiana 70112
Study Coordinator
504-568-7740
Jackson, Mississippi 39202
Study Coordinator
601-500-7660
Newark, New Jersey 07103
Study Coordinator
848-445-4357
The Bronx, New York 10467
Study Coordinator
718-920-2229
Chapel Hill, North Carolina 27514-7064
Study Coordinator
919-843-0720
Greensboro, North Carolina 27401
Study Coordinator
336-832-3275
Philadelphia, Pennsylvania 19107
Study Coordinator
214-985-4448
Pittsburgh, Pennsylvania 15213
Study Coordinator
412-648-9636
Columbia, South Carolina 29203
Study Coordinator
803-434-7703
Memphis, Tennessee 38105
Study Coordinator
901-595-3300
Nashville, Tennessee 37208
Study Coordinator
615-327-6353
Austin, Texas 78705
Study Coordinator
512-496-9899
Bellaire, Texas 77401
Study Coordinator
713-839-7111
Seattle, Washington 98104
Study Coordinator
206-667-2300
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC