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

Primary Purpose

Human Immunodeficiency Virus, HIV

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Islatravir
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Islatravir 47 mg

    Islatravir 52 mg

    Islatravir 57 mg

    Placebo

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
    Plasma ISL C12weeks will be determined.
    Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
    Plasma ISL C52weeks will be determined.

    Full Information

    First Posted
    November 2, 2021
    Last Updated
    September 8, 2023
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05115838
    Brief Title
    Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
    Official Title
    A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for HIV-1 Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 4, 2024 (Anticipated)
    Primary Completion Date
    October 2, 2025 (Anticipated)
    Study Completion Date
    October 2, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus, HIV

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    175 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Islatravir 47 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Islatravir 52 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Islatravir 57 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Islatravir
    Other Intervention Name(s)
    MK-8591
    Intervention Description
    ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo implantable rod placed subdermally on the upper arm.
    Primary Outcome Measure Information:
    Title
    Percentage of participants with ≥1 adverse events (AEs)
    Description
    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.
    Time Frame
    Up to 60 weeks
    Title
    Percentage of participants withdrawing from study treatment due to adverse event (AE)
    Description
    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.
    Time Frame
    Up to 52 weeks
    Secondary Outcome Measure Information:
    Title
    Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
    Description
    Plasma ISL C12weeks will be determined.
    Time Frame
    Week 12
    Title
    Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
    Description
    Plasma ISL C52weeks will be determined.
    Time Frame
    Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Links:
    URL
    http://www.merckclinicaltrials.com
    Description
    Merck Clinical Trials Information

    Learn more about this trial

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

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