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)

NCT07850609 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 8527-018
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV

Keywords

Prophylaxis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  Up to approximately 4 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

  Up to approximately 2 months

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) of Alimatravir in Plasma

  At designated time points (up to approximately 3 months)

• Time to Maximum Plasma Concentration (Tmax) of Alimatravir in Plasma

  At designated time points (up to approximately 3 months)

• Plasma Trough Concentration (Ctrough) of Alimatravir

  At designated time points (up to approximately 3 months)

• Plasma Estradiol Concentration

  Up to approximately 6.5 months

• Plasma Testosterone Concentration

  Up to approximately 6.5 months

Study Arms (1)

Alimatravir

EXPERIMENTAL

Alimatravir 11 mg will be taken once monthly (qm)

Drug: Alimatravir

Interventions

Alimatravir DRUG

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

Also known as: MK-8527

Alimatravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 29, 2026
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): December 2, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share