Trials / Withdrawn
WithdrawnNCT05130086
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Islatravir | 60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2024-03-25
- Completion
- 2024-03-25
- First posted
- 2021-11-22
- Last updated
- 2022-10-17
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05130086. Inclusion in this directory is not an endorsement.