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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 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.

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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

Conditions Studied

Human Immunodeficiency Virus (HIV) HIV Pre-exposure Prophylaxis

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

FieldValue
Enrollment Target 4,390 participants
Start Date 2025-07-31
Est. Completion 2027-07-22
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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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, categorized as Phase 3. The registered enrollment target is 4,390 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 265-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (1557% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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