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A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
NCT07044297 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG MK-8527
- DRUG FTC/TDF
- DRUG Placebo to MK-8527
- DRUG Placebo to FTC/TDF
Study Locations (20)
Alabama
- University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) — Birmingham
- USA Health University Hospitals ( Site 0020) — Mobile
California
- UCLA Center for Clinical AIDS Research and Education ( Site 0004) — Los Angeles
- Bridge HIV - San Francisco Department of Public Health ( Site 0001) — San Francisco
Florida
- University of Miami RAPID Research ( Site 0003) — Miami
- Orlando Immunology Center ( Site 0021) — Orlando
North Carolina
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008) — Chapel Hill
- Regional Center for Infectious Diseases ( Site 0018) — Greensboro
Pennsylvania
- Philadelphia Fight Community Health Centers ( Site 0011) — Philadelphia
- University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022) — Pittsburgh
Tennessee
- St. Jude Children's Research Hospital ( Site 0026) — Memphis
- Meharry Medical College ( Site 0013) — Nashville
District of Columbia
- Whitman-Walker Institute ( Site 0016) — Washington D.C.
Georgia
- Hope Clinic of the Emory Vaccine Center ( Site 0009) — Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,390 participants |
| Start Date | 2025-07-31 |
| Est. Completion | 2027-07-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07044297
The ClinicalTrials.gov registry entry for NCT07044297 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 4 interventions — of which MK-8527 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07044297 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07044297 about?
NCT07044297 is a clinical study titled "A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)". 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 onc...
What is the current status of trial NCT07044297?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,390 participants. The study started on 2025-07-31. Estimated completion is 2027-07-22.
What conditions does trial NCT07044297 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07044297?
The interventions under investigation include: MK-8527 (DRUG), FTC/TDF (DRUG), Placebo to MK-8527 (DRUG), Placebo to FTC/TDF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07044297?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07044297 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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