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NCT07850609Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
23 Sept 2026
Start date
29 Oct 2026
Primary completion date
2 Dec 2027
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
HIV
NCT number
NCT07850609

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • From 29 Oct 2026 to the primary completion date, 2 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.