Recruiting

Phase 2

AlimatravirA 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

Code:

NCT07850609

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Alimatravir

Study Details

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

Study ID

NCT07850609

Start date

Oct 27, 2026

Status verified date

Nov, 2026

Completion date

Dec 2, 2027

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Alimatravir

Alimatravir 11 mg will be taken once monthly (qm)

Interventions

Alimatravir

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

Primary outcome measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 4 months ]
Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 2 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@MSD.com

Locations

Bridge HIV - San Francisco Department of Public Health ( Site 0002)

Recruiting

San Francisco, California, United States, 94102

Contacts

Study Coordinator

628-217-7400

Whitman-Walker Institute ( Site 0008)

Recruiting

Washington D.C., District of Columbia, United States, 20032

Contacts

Study Coordinator

202-207-2510

Fenway Health ( Site 0004)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-927-6400

Mazzoni Center ( Site 0010)

Recruiting

Philadelphia, Pennsylvania, United States, 19147

Contacts

Study Coordinator

215-563-0652

Maple Leaf Research ( Site 0102)

Recruiting

Toronto, Ontario, Canada, M5G 1K2

Contacts

Study Coordinator

4164657936

Clinique de médecine Urbaine du Quartier Latin ( Site 0101)

Recruiting

Montreal, Quebec, Canada, H2L 4E9

Contacts

Study Coordinator

5142855500

Gestion clinique médicale l'Actuel ( Site 0100)

Recruiting

Montreal, Quebec, Canada, H2L 4P9

Contacts

Study Coordinator

5145241001

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

Prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.