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NOT YET RECRUITING
NCT07850609
PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-10-29

Completion Date

2027-12-02

Last Updated

2026-09-30

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Alimatravir

11 mg tablets taken orally once monthly (qm) for a total of 3 doses