Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)

NCT05115838 | Withdrawn Phase 2 FDA Drug

• 3 other identifiers: 8591-043MK-8591-0432021-003414-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.

Conditions

Human Immunodeficiency Virus; HIV

Outcome Measures

Primary Outcomes (2)

• Percentage of participants with ≥1 adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to 60 weeks

• Percentage of participants withdrawing from study treatment due to adverse event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to 52 weeks

Secondary Outcomes (2)

• Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)

  Week 12

• Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)

  Week 52

Study Arms (4)

Islatravir 47 mg

EXPERIMENTAL

Participants receive an ISL 47 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Drug: Islatravir

Islatravir 52 mg

EXPERIMENTAL

Participants receive an ISL 52 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Drug: Islatravir

Islatravir 57 mg

EXPERIMENTAL

Participants receive an ISL 57 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Drug: Islatravir

Placebo

PLACEBO COMPARATOR

Participants receive a placebo implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Drug: Placebo

Interventions

Islatravir DRUG

ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.

Also known as: MK-8591

Islatravir 47 mg; Islatravir 52 mg; Islatravir 57 mg

Placebo DRUG

Placebo implantable rod placed subdermally on the upper arm.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health
• Is confirmed human immunodeficiency virus (HIV)-uninfected
• Is at low risk of HIV infection
• For males, uses contraception in accordance with local regulations regarding contraception use for those participating in clinical trials
• For females, is not pregnant or breastfeeding and one of the following applies:
• Is not a participant of childbearing potential (POCBP)
• Is a POCBP and uses an acceptable contraception method or is abstinent

You may not qualify if:

• Has an active diagnosis of hepatitis (B or C) due to any cause
• Has a history of malignancy ≤5 years before signing informed consent
• Has a history or current evidence of any condition that might confound study results or interfere with study participation
• Has a history of keloid in upper arm or presence of tattoo, scar, or other physical finding that could interfere with implant placement (the contralateral arm may be used if the findings are limited to 1 arm)
• Is taking or is expected to take immunosuppressants during the study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

islatravir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 10, 2021
• Study Start: January 4, 2024
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share