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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520610-58-00

Acronym

MK-8527-011

Enrollment

100

Registered

2025-10-03

Start date

2025-11-19

Completion date

Unknown

Last updated

2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 prevention

Brief summary

Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection, Number of Participants Who Experience At Least One Adverse Event (AE), Number of Participants Who Discontinue Study Intervention Due to an AE

Interventions

DRUGPlacebo for MK-8527

DRUGTENOFOVIR DISOPROXIL AND EMTRICITABINE

DRUGPlacebo for Emtricitabine/Tenofovir Disoproxil

DRUGMK-8527 F1

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection, Number of Participants Who Experience At Least One Adverse Event (AE), Number of Participants Who Discontinue Study Intervention Due to an AE	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026