RECRUITING

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

Description

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

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis
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Related Conditions:

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

Study Overview

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Study Details

Study overview

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

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

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

Condition
Human Immunodeficiency Virus (HIV)
Intervention / Treatment

-

Contacts and Locations

San Francisco

Bridge HIV - San Francisco Department of Public Health, San Francisco, California, United States, 94102

Greensboro

Regional Center for Infectious Diseases, Greensboro, North Carolina, United States, 27401

Bellaire

Saint Hope Foundation, Inc, Bellaire, Texas, United States, 77401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
  • * Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
  • * 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
  • * Weighs ≥35 kg
  • * Has hypersensitivity or other contraindication to any component of the study interventions
  • * Has evidence of acute or chronic hepatitis B infection
  • * 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
  • * Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
  • * Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
  • * 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
  • * Is expecting to donate eggs at any time during the study

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2027-10-20