A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT07044297
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- HIV Pre-Exposure Prophylaxis
- Human Immunodeficiency Virus (HIV)
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- MK-8527 — DRUGOral tablet
- FTC/TDF — DRUGOral tablet
- Placebo to MK-8527 — DRUGPlacebo tablet matched to MK-8527
- Placebo to FTC/TDF — DRUGPlacebo tablet matched to FTC/TDF
Study Details
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
Key Dates
- Start date
- Jul 31, 2025
- Status verified
- Jun 2026
- Primary completion
- Jul 22, 2027
- Completion
- Jul 22, 2027
Study Design
- Enrollment
- 4,390 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: MK-8527Participants 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/TDFParticipants 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 Measure
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection [ Time Frame: Up to approximately 2 years ]
Central Contacts
- Toll Free Number1-888-577-8839
Locations (23)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) | Birmingham | Alabama | 35222 | Study Coordinator 205-934-2490 |
| USA Health University Hospitals ( Site 0020) | Mobile | Alabama | 36617 | Study Coordinator 251-471-7000 |
| UCLA Center for Clinical AIDS Research and Education ( Site 0004) | Los Angeles | California | 90035 | Study Coordinator 310-843-2015 |
| Bridge HIV - San Francisco Department of Public Health ( Site 0001) | San Francisco | California | 94102 | Study Coordinator 628-217-7400 |
| Whitman-Walker Institute ( Site 0016) | Washington D.C. | District of Columbia | 20032 | Study Coordinator 202-207-2510 |
| University of Miami RAPID Research ( Site 0003) | Miami | Florida | 33136 | Study Coordinator 305-243-4378 |
| Orlando Immunology Center ( Site 0021) | Orlando | Florida | 32803 | Study Coordinator 407-374-0220 |
| Hope Clinic of the Emory Vaccine Center ( Site 0009) | Decatur | Georgia | 30030 | Study Coordinator 404-712-1370 |
| University of Illinois Chicago ( Site 0027) | Chicago | Illinois | 60612 | Study Coordinator 312-864-4578 |
| University Medical Center New Orleans ( Site 0024) | New Orleans | Louisiana | 70112 | Study Coordinator 504-568-7740 |
| Open Arms Healthcare Center ( Site 0025) | Jackson | Mississippi | 39202 | Study Coordinator 601-500-7660 |
| Rutgers New Jersey Medical School ( Site 0010) | Newark | New Jersey | 07103 | Study Coordinator 848-445-4357 |
| Montefiore Medical Center ( Site 0017) | The Bronx | New York | 10467 | Study Coordinator 718-920-2229 |
| NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008) | Chapel Hill | North Carolina | 27514-7064 | Study Coordinator 919-843-0720 |
| Regional Center for Infectious Diseases ( Site 0018) | Greensboro | North Carolina | 27401 | Study Coordinator 336-832-3275 |
| Philadelphia Fight Community Health Centers ( Site 0011) | Philadelphia | Pennsylvania | 19107 | Study Coordinator 214-985-4448 |
| University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022) | Pittsburgh | Pennsylvania | 15213 | Study Coordinator 412-648-9636 |
| Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007) | Columbia | South Carolina | 29203 | Study Coordinator 803-434-7703 |
| St. Jude Children's Research Hospital ( Site 0026) | Memphis | Tennessee | 38105 | Study Coordinator 901-595-3300 |
| Meharry Medical College ( Site 0013) | Nashville | Tennessee | 37208 | Study Coordinator 615-327-6353 |
| Central Texas Clinical Research ( Site 0014) | Austin | Texas | 78705 | Study Coordinator 512-496-9899 |
| Saint Hope Foundation, Inc. ( Site 0015) | Bellaire | Texas | 77401 | Study Coordinator 713-839-7111 |
| Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002) | Seattle | Washington | 98104 | Study Coordinator 206-667-2300 |
Find similar trials in Birmingham, AL
By research site
University of Alabama at Birmingham-UAB 1917 Research Clinic· Birmingham, ALUSA Health University Hospitals· Mobile, ALUCLA Center for Clinical AIDS Research and Education· Los Angeles, CABridge HIV - San Francisco Department of Public Health· San Francisco, CAWhitman-Walker Institute· Washington D.C., DCUniversity of Miami RAPID Research· Miami, FL
Related Studies
- Persuasive Health Communication Intervention for HIV/HCVRecruiting · University of South Florida · New York, New York
- Client-Centered Care Coordination for Black Men Who Have Sex With MenEnrolling By Invitation · University of Maryland, Baltimore · Washington D.C., District of Columbia
- Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical CarePHASE4 · Recruiting · New York University · New York, New York
- Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)Not Yet Recruiting · University of Georgia · Colbert, Georgia