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NCT07044297 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
A Phase 3 study of Human Immunodeficiency Virus (HIV) and HIV Pre-exposure Prophylaxis, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 4,390
- Enrollment target
- 20
- Study locations
NCT07044297: Recruiting Phase 3 study of Human Immunodeficiency Virus (HIV) and HIV Pre-exposure Prophylaxis, sponsored by Merck Sharp & Dohme.
NCT07044297 is a Phase 3 study of Human Immunodeficiency Virus (HIV) and HIV Pre-exposure Prophylaxis that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 4,390 participants, above the 265-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (1557% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07044297, a Phase 3 study of Human Immunodeficiency Virus (HIV) and HIV Pre-exposure Prophylaxis, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 4,390 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The number of participants with adjudicated HIV-1 infection will be determined.
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 |
What NCT07044297 shows while recruiting
NCT07044297 is an interventional study that assigns participants to a tested intervention. Its 4,390 participants enrollment target places it among the larger protocols in the corpus, above the 265-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (1557% higher).
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.
NCT07044297 names 20 study sites across 14 states, led by Alabama, California, Florida.
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.
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).
Who is sponsoring clinical trial NCT07044297?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07044297's enrollment target sits among peer trials
4,390 1st of 18 higher than 18 of 18 other Human Immunodeficiency Virus (HIV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus (HIV) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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