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Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045507
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.

Condition or disease Intervention/treatment Phase
HIV HIV Pre-exposure Prophylaxis Drug: MK-8527 Drug: Placebo to MK-8527 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
Actual Study Start Date : November 8, 2023
Estimated Primary Completion Date : February 18, 2025
Estimated Study Completion Date : February 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: MK-8527 Low Dose QM
Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
 Drug: MK-8527
MK-8527 capsule
Experimental: MK-8527 Medium Dose QM
Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
 Drug: MK-8527
MK-8527 capsule
Experimental: MK-8527 High Dose QM
Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
 Drug: MK-8527
MK-8527 capsule
Placebo Comparator: Placebo to MK-8527
Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
 Drug: Placebo to MK-8527
Placebo capsule matched to MK-8527


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With ≥1 Adverse Event (AE) [ Time Frame: Up to ~28 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.

  2. Number of Participants Discontinuing From Study Therapy Due to AE [ Time Frame: Up to ~20 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.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 [ Time Frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose ]
    The AUC0-last of MK-8527 will be determined.

  2. Maximum Plasma Concentration (Cmax) of MK-8527 [ Time Frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose ]
    The Cmax of MK-8527 will be determined.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
  • Has low-risk of HIV infection
  • Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse

Exclusion Criteria:

  • Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])
  • Prior use of MK-8527 or islatravir (MK-8591)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045507


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06045507    
Other Study ID Numbers: 8527-007
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections