A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Public ClinicalTrials.gov record NCT07044297. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07044297
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,390 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2025 (Actual)
- Primary completion
- Jul 22, 2027 (Estimated)
- Completion
- Jul 22, 2027 (Estimated)
- Last update posted
- Sep 18, 2026
2025 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) | Birmingham | Alabama | 35222 | — |
| USA Health University Hospitals ( Site 0020) | Mobile | Alabama | 36617 | — |
| UCLA Center for Clinical AIDS Research and Education ( Site 0004) | Los Angeles | California | 90035 | — |
| Bridge HIV - San Francisco Department of Public Health ( Site 0001) | San Francisco | California | 94102 | — |
| Whitman-Walker Institute ( Site 0016) | Washington D.C. | District of Columbia | 20032 | — |
| University of Miami RAPID Research ( Site 0003) | Miami | Florida | 33136 | — |
| Orlando Immunology Center ( Site 0021) | Orlando | Florida | 32803 | — |
| Hope Clinic of the Emory Vaccine Center ( Site 0009) | Decatur | Georgia | 30030 | — |
| University of Illinois Chicago ( Site 0027) | Chicago | Illinois | 60612 | — |
| University Medical Center New Orleans ( Site 0024) | New Orleans | Louisiana | 70112 | — |
| Open Arms Healthcare Center ( Site 0025) | Jackson | Mississippi | 39202 | — |
| Rutgers New Jersey Medical School ( Site 0010) | Newark | New Jersey | 07103 | — |
| Montefiore Medical Center ( Site 0017) | The Bronx | New York | 10467 | — |
| NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008) | Chapel Hill | North Carolina | 27514-7064 | — |
| Regional Center for Infectious Diseases ( Site 0018) | Greensboro | North Carolina | 27401 | — |
| Philadelphia Fight Community Health Centers ( Site 0011) | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022) | Pittsburgh | Pennsylvania | 15213 | — |
| Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007) | Columbia | South Carolina | 29203 | — |
| St. Jude Children's Research Hospital ( Site 0026) | Memphis | Tennessee | 38105 | — |
| Meharry Medical College ( Site 0013) | Nashville | Tennessee | 37208 | — |
| Central Texas Clinical Research ( Site 0014) | Austin | Texas | 78705 | — |
| Saint Hope Foundation, Inc. ( Site 0015) | Bellaire | Texas | 77401 | — |
| Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002) | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07044297, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07044297 live on ClinicalTrials.gov.