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A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4580

Last updated 2026-05-19

No results posted yet for this 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 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

  • Human Immunodeficiency Virus (HIV)
  • HIV Pre-Exposure Prophylaxis

Interventions

DRUG

MK-8527

Oral tablet

DRUG

Emtricitabine/tenofovir disoproxil (FTC/TDF)

Oral tablet

DRUG

Placebo matched to MK-8527

Placebo oral tablet matched to MK-8527

DRUG

Placebo matched to FTC/TDF

Placebo oral tablet matched to FTC/TDF

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2027-10-18
Completion
2027-10-18
FDA Drug
Yes

Countries

  • Kenya
  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071623 on ClinicalTrials.gov