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Alimatravir in Transgender and Gender Diverse Individuals on Gender-Affirming Hormone Therapy
NCT07850609Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2026
- Primary completion
- Dec 2027
- Sponsor
- Merck & Co.
- Drugs
- alimatravir
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 2, open-label, single-arm trial of alimatravir in human immunodeficiency virus infection (HIV), sponsored by Merck & Co. Primary endpoints: Number of Participants Who Experience an Adverse Event (AE) at 4 months and Number of Participants Who Discontinue Study Treatment Due to an AE at 2 months. Planned start Oct 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Alimatravir
Alimatravir 11 mg orally once monthly for 3 doses
03
Who it enrols
HIV-uninfected transgender or gender diverse individuals on stable gender-affirming hormone therapy with low likelihood of HIV exposure, without hepatitis B or recent malignancy.
04
Endpoints
Primary
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Discontinue Study Treatment Due to an AE
Secondary
Maximum Plasma Concentration (Cmax) of Alimatravir in Plasma
Time to Maximum Plasma Concentration (Tmax) of Alimatravir in Plasma
Plasma Trough Concentration (Ctrough) of Alimatravir
Plasma Estradiol Concentration
Plasma Testosterone Concentration
Plasma Dihydrotestosterone Concentration
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