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

April 19, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Rambam Health Care Campus ( Site 0003)
      • Jerusalem, Israel, 9112001
        • Active, not recruiting
        • Hadassah Medical Center ( Site 0002)
      • Ramat Gan, Israel, 5265601
        • Active, not recruiting
        • Sheba Medical Center ( Site 0001)
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Recruiting
        • Josha Research ( Site 0023)
        • Contact:
          • Study Coordinator
          • Phone Number: +27825724468
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2092
        • Recruiting
        • Helen Joseph Hospital ( Site 0024)
        • Contact:
          • Study Coordinator
          • Phone Number: +27834158967
      • Johannesburg, Gauteng, South Africa, 2001
        • Recruiting
        • Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)
        • Contact:
          • Study Coordinator
          • Phone Number: +27728086113
    • Kwazulu-Natal
      • Ladysmith, Kwazulu-Natal, South Africa, 3370
        • Recruiting
        • Qhakaza Mbokodo Research Clinic ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: +27824588969
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Desmond Tutu Health Foundation ( Site 0021)
        • Contact:
          • Study Coordinator
          • Phone Number: 27214066964
  • United States
    • California
      • North Hollywood, California, United States, 91606
        • Active, not recruiting
        • Velocity Clinical Research, North Hollywood ( Site 0054)
      • San Francisco, California, United States, 94102
        • Recruiting
        • Bridge HIV- San Francisco Department of Public Health ( Site 0042)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-793-8877
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • Recruiting
        • Velocity Clinical Research, Hallandale Beach ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-243-0088
      • Immokalee, Florida, United States, 34142
        • Recruiting
        • Community Medical Care Center ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 239-657-5800
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • Velocity Clinical Research, Rockville ( Site 0048)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-762-5020
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Fenway Health ( Site 0043)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-927-6087
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Albuquerque Clinical Trials, Inc. ( Site 0044)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-224-7407
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-320-1904
    • Texas
      • Dallas, Texas, United States, 75208
        • Recruiting
        • Prism Health North Texas, Oak Cliff Health Center ( Site 0045)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-673-9463
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-520-4268

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

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: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to ~28 weeks
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.
Up to ~20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
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.
Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose

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 (Actual)

November 8, 2023

Primary Completion (Estimated)

February 18, 2025

Study Completion (Estimated)

February 18, 2025

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8527-007

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.

Clinical Trials on HIV

Clinical Trials on MK-8527

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe