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

Last updated: March 11, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

2

Condition

Hiv

Treatment

MK-8527

Placebo to MK-8527

Clinical Study ID

NCT06045507
8527-007
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result beforerandomization

  • Has low-risk of HIV infection

  • Females: is not pregnant or breastfeeding and is either not a participant ofchildbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception oris abstinent from penile-vaginal intercourse

Exclusion

Exclusion Criteria:

  • Has hypersensitivity or other contraindication to any of the components of the studyinterventions 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 Design

Total Participants: 352
Treatment Group(s): 2
Primary Treatment: MK-8527
Phase: 2
Study Start date:
November 08, 2023
Estimated Completion Date:
February 12, 2025

Connect with a study center

  • Rambam Health Care Campus ( Site 0003)

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center ( Site 0002)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Sheba Medical Center ( Site 0001)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Josha Research ( Site 0023)

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Helen Joseph Hospital ( Site 0024)

    Johannesburg, Gauteng 2092
    South Africa

    Site Not Available

  • Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)

    Johannesburg, Gauteng 2000
    South Africa

    Site Not Available

  • Qhakaza Mbokodo Research Clinic ( Site 0026)

    Ladysmith, Kwazulu-Natal 3370
    South Africa

    Site Not Available

  • Desmond Tutu Health Foundation ( Site 0021)

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Velocity Clinical Research, North Hollywood ( Site 0054)

    North Hollywood, California 91606
    United States

    Site Not Available

  • Bridge HIV- San Francisco Department of Public Health ( Site 0042)

    San Francisco, California 94102
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach ( Site 0052)

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Community Medical Care Center ( Site 0056)

    Immokalee, Florida 34142
    United States

    Site Not Available

  • Velocity Clinical Research Rockville ( Site 0048)

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Velocity Clinical Research, Rockville ( Site 0048)

    Rockville, Maryland 20854
    United States

    Active - Recruiting

  • Fenway Health ( Site 0043)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc. ( Site 0044)

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Prism Health North Texas, Oak Cliff Health Center ( Site 0045)

    Dallas, Texas 75208
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)

    Seattle, Washington 98104
    United States

    Site Not Available

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