Merck Sharp & Dohme LLC
The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for human immunodeficiency virus 1 (HIV-1) infection.
Human Immunodeficiency Virus (HIV) Infections
Islatravir
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 0 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | A Phase 2 Open-Label Study to Evaluate the Safety and Pharmacokinetics of Oral Islatravir Once-Monthly in Trans and Gender Diverse Individuals on Gender-Affirming Hormone Therapy and at Low-Risk for HIV-1 Infection |
Actual Study Start Date : | October 17, 2022 |
Estimated Primary Completion Date : | March 25, 2024 |
Estimated Study Completion Date : | March 25, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Islatravir 60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks |
Drug: Islatravir |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.