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A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)

NCT05130086 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-10-17

No results posted yet for this study

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

  • Human Immunodeficiency Virus (HIV) Infections

Interventions

DRUG

Islatravir

60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2024-03-25
Completion
2024-03-25
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130086 on ClinicalTrials.gov