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A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018)

Protocol Title: A Phase 2 Open-label Study to Evaluate the Safety and Pharmacokinetics of MK-8527 Oral Once-monthly in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of HIV-1 Exposure

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Is confirmed human immunodeficiency virus (HIV)-uninfected
* Is a transgender or gender diverse (TGD) person, ie, a person whose gender identity differs from the sex that was assigned at birth
* Is on stable gender-affirming hormone therapy (GAHT) and does not intend to change therapy through 2 months after the last dose of study intervention
* Has a low likelihood of HIV exposure

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* 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

About the study

The goal of this study is to learn about the safety of alimatravir (MK-8527) in transgender and gender-diverse people and if they tolerate it.

What is being tested

• Alimatravir (drug)

Sponsor: Merck Sharp & Dohme LLC · Participants: 80 · Started: Oct 27, 2026

Contact the study team

• Toll Free Number · Phone: 1-888-577-8839

Official record on ClinicalTrials.gov — NCT07850609

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.