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

NCT ID: NCT05130086

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2024-03-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Islatravir

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

Group Type: EXPERIMENTAL

Islatravir

Intervention Type: DRUG

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

Interventions

Islatravir

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

Intervention Type: DRUG

Other Intervention Names

MK-8591

Eligibility Criteria

Inclusion Criteria

• Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before allocation to study intervention.
• Is on stable GAHT and does not intend to change therapy through Week 4 of the study.
• Has a low-risk of HIV infection.
• Identifies with a gender that is different from that assigned at birth.
• A participant assigned female at birth is eligible if not pregnant or chest-feeding and is not of childbearing potential (POCBP) or: Is a POCBP and using an acceptable contraceptive method, or be abstinent from penile-vaginal intercourse with an individual capable of producing sperm (abstinent on a long term and persistent basis); a POCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; If a urine test cannot be confirmed as negative (e.g, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive; the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant assigned female at birth with an early undetected pregnancy; contraceptive use by participant assigned female at birth should be consistent with local regulations.

Exclusion Criteria

• Has known current or chronic history of liver disease (e.g, non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction.
• Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ anal cancers.
• Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time (past or current use).
• Is currently participating in or has participated in a clinical study with an investigational compound or device, within 30 days before Day 1 through the duration of the study.
• Is expecting to conceive or donate eggs at any time during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-8591-035

Identifier Type: OTHER

Identifier Source: secondary_id

8591-035

Identifier Type: -

Identifier Source: org_study_id