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

September 8, 2023 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

175

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Islatravir 47 mg
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
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Other Names:
  • MK-8591
Experimental: Islatravir 52 mg
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
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Other Names:
  • MK-8591
Experimental: Islatravir 57 mg
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
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Other Names:
  • MK-8591
Placebo Comparator: Placebo
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
Placebo implantable rod placed subdermally on the upper arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with ≥1 adverse events (AEs)
Time Frame: Up to 60 weeks
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)
Time Frame: Up to 52 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
Time Frame: Week 12
Plasma ISL C12weeks will be determined.
Week 12
Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
Time Frame: Week 52
Plasma ISL C52weeks will be determined.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 4, 2024

Primary Completion (Estimated)

October 2, 2025

Study Completion (Estimated)

October 2, 2025

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8591-043
  • 2021-003414-39 (EudraCT Number)
  • MK-8591-043 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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