MK-8527 for HIV-1 infection

Inclusion criteria

• {"criterion_text":"-Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results"}
• {"criterion_text":"-Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person"}
• {"criterion_text":"-Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening"}
• {"criterion_text":"-Is ≥16 years of age"}
• {"criterion_text":"-Weighs ≥35 kg"}

Exclusion criteria

• {"criterion_text":"-Has hypersensitivity or other contraindication to any component of the study interventions"}
• {"criterion_text":"-Has evidence of acute or chronic hepatitis B infection"}
• {"criterion_text":"-Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers"}
• {"criterion_text":"-Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time"}
• {"criterion_text":"-Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration"}
• {"criterion_text":"-Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1"}
• {"criterion_text":"-Is expecting to donate eggs at any time during the study"}

Primary endpoints

• {"endpoint_text":"-Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection","definition_or_measurement_approach":"As described in objectives: assessed by the incidence rate per year of adjudicated HIV-1 infections."}
• {"endpoint_text":"-Number of Participants Who Experience At Least One Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing at least one adverse event during the study."}
• {"endpoint_text":"-Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue the study intervention because of an adverse event."}

Methods

• K2 recruitment documents indicate planned use of recruitment brochure (K2_Recruitment Doc Brochure_FRA_FR), social media (K2_Recruitment Doc Social Media_FRA_FR), flyer (K2_Recruitment Doc Flyer_FRA_FR), and poster (K2_Recruitment Doc Poster_FRA_FR) — documents are associated with the France Part II submission.
• Recruitment arrangements document K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM02 is included for France.

France

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

160

Number Of Sites

3

Number Of Participants

100

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

PPD Global Central Labs

Responsibilities

code:4

Name

Signant Health Global LLC

Responsibilities

code:3

Name

Pharma Medica Research Inc.

Responsibilities

code:4

Third parties

• {"country":"Canada","full_name":"Pharma Medica Research Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement and Travel Support","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"University Of Colorado Foundation","duties_or_roles":"code:4","organisation_type":"Educational Institution"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Monogram Biosciences Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"AG Mednet Inc.","duties_or_roles":"Adjudication data entry tool","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}