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)

Conditions: HIV

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: Yes

Phase: PHASE2

Enrollment: 80

Sponsor: Merck Sharp & Dohme LLC

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07850609). StuddyBuddy aggregates publicly available trial information.