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

NCT05130086 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 8591-035MK-8591-035
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Participants with one or more adverse events (AEs)

  Number of participants with one or more AEs will be reported.

  Up to 26 weeks

• Participants with an AE leading to discontinuation of study intervention

  Number of participants with an AE leading to discontinuation of study intervention will be reported.

  Up to 20 weeks

Secondary Outcomes (4)

• Area Under the Curve (AUC) of plasma islatravir (ISL)

  Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24

• Maximum concentration (Cmax) of plasma ISL

  Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24

• Trough concentration (Ctrough) of plasma ISL

  Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24

• Apparent terminal half-life (t1/2) of plasma ISL

  Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24

Study Arms (1)

Islatravir

EXPERIMENTAL

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

Drug: Islatravir

Interventions

Islatravir DRUG

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

Also known as: MK-8591

Islatravir

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants will include anyone who identifies with a gender that is different from the sex assigned at birth (e.g., transgender woman, transgender man, gender nonbinary, etc.), including those with differences in sex development (sometimes called intersex).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Interventions

islatravir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: October 17, 2022
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share